EUROPEAN COMMISSION

Strasbourg, 16.12.2025

SWD(2025) 1051 final

COMMISSION STAFF WORKING DOCUMENT

EVALUATION

on the Targeted evaluation of Regulation (EU)2017/745 on Medical Devices and Regulation (EU)2017/746 on In vitro Diagnostic Medical Devices

Accompanying the document

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

{COM(2025) 1023 final} - {SWD(2025) 1050 final} - {SWD(2025) 1052 final}

Table of contents

1.Introduction

2.What was the expected outcome of the intervention?

2.1.    Description of the intervention and its objectives    

2.1.1.    Background to intervention (i.e. move from Directives to Regulations)    

2.1.2.    Problems identified under the previous regulatory framework    

2.1.3.    Objectives and expected impacts of the new regulatory framework (i.e. Regulations)    

2.2.    Point(s) of comparison    

3.How has the situation evolved over the evaluation period?

3.1.    Current state of play    

3.2.    Implementation progress    

4.Evaluation findings (analytical part)

4.1.    To what extent was the intervention successful and why?    

4.1.1.    Effectiveness    

4.1.2.    Efficiency    

4.1.3.    Coherence    

4.2.    How did the EU intervention make a difference and to whom?    

4.3.    Is the intervention still relevant?    

5.What are the conclusions and lessons learned?

5.1.    Conclusions    

5.2.    Lessons learned    

Annex I: Procedural Information

Annex II. Methodology and Analytical models used

Annex III. Evaluation matrix and, where relevant, Details on answers to the evaluation questions (by criterion)

Annex IV. Overview of benefits and costs, Table on simplification and burden reduction

Annex V. Stakeholders consultation - Synopsis report

Annex VI. Effectiveness Tables: Evidence and Scoring

Annex VII. Explanatory diagrams

Annex VIII. Stakeholder Mapping

List of acronyms and abbreviations

Medical devices and in vitro diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. There are over 2 000 000 medical technologies in Europe 1 . Examples of medical devices are sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. IVDs are used to perform tests on samples, and examples include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics. Moreover, around two thirds of all clinical decisions are based on information provided by IVDs 2 . In 2025, the European medical device market is estimated at approximately 170 bn EUR, making it the second largest in the world following the US 3 . Europe has a positive medical devices trade balance of 5 bn EUR (2024) with more than 930 000 people employed in this industry in Europe (2025).

In the EU, medical devices and IVDs are regulated by Regulation (EU) 2017/745 on medical devices (MDR) 4 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) 5 . Hereafter, these two Regulations are referred to jointly as ‘the Regulations’. They were adopted in 2017 and aim to ensure that only safe and performant devices are on the EU market, to protect patient safety and public health while supporting innovation. They aim to create a robust, transparent and sustainable legal framework, aligned with international practices, improving clinical safety and fair market access.

Considering the extent of the changes introduced by the Regulations, transition periods were envisaged to ensure a smooth transition to the new rules for legacy devices 6 . The transition periods continue to apply and have been extended several times due to challenges in the implementation of the Regulations. These include mitigating the risk of shortages, and delays in the deployment and mandatory use of the European database on medical devices (EUDAMED). These challenges were further exacerbated by the impact of the COVID-19 pandemic, which particularly affected clinical investigations, onsite audits and global supply chains. In view of the significant challenges encountered during this transition, while an evaluation is legally required by May 2027, the Commission launched a targeted evaluation of the Regulations in 2024.

Purpose of the evaluation

The targeted evaluation assesses the performance of the Regulations with a view to providing a basis for reflections on future actions. Focus is placed on their impact on the availability of devices, including devices for small populations (e.g. ‘orphan devices’) and innovative devices. An important focus is also given to costs and administrative burdens, especially for SMEs, as well as the benefits arising from the legislation.

Covering all evaluation criteria (effectiveness, efficiency, coherence, relevance, EU added value), the evaluation considers whether the objectives of the Regulations have been achieved or can be achieved by the end of the extended transition periods, taking into account the current regulatory framework and the ways of implementing it. It also assesses the efficiency of the Regulations and the cost benefit balance, and their coherence including with other EU legislation. It analyses the relevance of the Regulations and whether they are “fit for purpose” to meet the current and future needs of both patients and stakeholders. It will also assess the added value of acting at EU level.

While the Regulations have not been fully implemented yet, several signals have pointed to some potential systemic challenges affecting market availability, legal certainty, and competitiveness, among others. This evaluation therefore intends to assess whether the regulatory framework is on track to achieve its objectives within the extended transitional period, to identify any systemic inefficiencies or inconsistencies that may require further monitoring and to inform future policy decisions and potential for simplification.

Scope of the evaluation

This evaluation covers the period between the adoption of the legislation (5 April 2017) and 31 December 2024 7 . It covers both the basic acts as well as implementing and delegated acts 8 adopted during this timeframe. It performs an assessment of the provisions of the Regulations that were implemented or for which the implementation process had been initiated during this timeframe. The geographical scope of the evaluation covers the implementation of the Regulations on the ‘Union market’, namely in the 27 EU Member States, the three European Economic Area (EEA) countries and Türkiye 9 . It also examines activities carried out based on bilateral agreements and multi-lateral cooperation (primarily the International Medical Device Regulators Forum (IMDRF)), and their impacts on safety, availability and trade.

Methodology and data

The evaluation has been designed on the basis of an evaluation matrix (Annex III) which operationalises the five evaluation criteria into a series of evaluation questions. It draws on a broad evidence base but given that no single source is complete or fully representative, the evaluation applies triangulation, including a scoring system to synthesise findings. The ex-post analysis is subject to several limitations that need to be considered when interpreting the results. Annex II presents the methodology applied, its robustness and limitations.

2.1.Description of the intervention and its objectives

2.1.1.Background to intervention (i.e. move from Directives to Regulations)

The Regulations were introduced to replace the previous regulatory framework consisting of three Directives 10  in place since the 1990s, as they were found to have multiple problems that undermined the main objectives of the Directives, i.e. the safety of medical devices, their free circulation within the internal market and issues arising from insufficient data and information on medical devices. The intervention logic (Figure 1) is a reconstruction of the logic at the time of the adoption of the Regulations in 2017. It consists of the problems identified under the Directives, the drivers that led to these problems and their consequences. It outlines the objectives of the introduced Regulations, as well as the expected inputs and outputs to achieve the expected results and impacts.

Several policy options addressing problems identified in the 2012 Impact Assessment 11   that accompanied the legislative proposals were reflected in the Regulations. Problems included ‘challenge to the uniform interpretation and implementation of the legal requirements as well as to the coordination of the activities of the national competent authorities’ and differences in the designation and monitoring of notified bodies, leading to ‘an uneven level of protection of the patients, users and public health’ (see further section 2.1.2). The introduction of the Regulations was closely linked to the objectives of the Third EU Health Programme (2014-2020) 12 , namely objective III (contribute to innovative, efficient and sustainable health systems) and objective IV (facilitate access to better and safer healthcare for EU citizens). The Regulations introduced key health policy goals outlined in the wider health programme (see section 2.1.3).

2.1.2.Problems identified under the previous regulatory framework 

For the purpose of this evaluation, the 7 problems identified in the Impact Assessment 13  have been re-defined into three major problems (see Figure 2 Revised intervention logic – Drivers & Problems):

Problem 1 – Insufficient safety of some medical devices

By late 2011, the medical device EU regulatory framework faced intense scrutiny from both the media 14 and the political spheres 15 , in particular after findings that Poly Implant Prothèse (PIP) used for breast implants had, over several years, been manufactured with industrial silicone instead of medical grade silicone contrary to the notified body’s approval, resulting in harm to thousands of women around the world. Safety issues were also identified with other medical devices, such as certain metal-on-metal hip joint replacements 16 , 17 or urogynaecological surgical meshes 18 , 19 . These safety issues pointed to insufficient clinical data having been collected for some devices, a lack of involvement of scientific expertise in regulatory processes, an insufficient level of oversight of notified bodies, insufficient reporting of manufacturers in the post market phase using a harmonised set of criteria, and a lack of coordination between Member States on safety issues.

Problem 2 – Obstacles to the functioning of the internal market

In addition to the 27 EU Member States, the four European Free trade Agreement (EFTA) countries and Türkiye also adopted the Directives, creating a single market of 32 countries. This posed challenges for implementation, enforcement of legal requirements and coordination among national authorities. The internal market was fragmented for several reasons, including imprecise legal requirements on the designation and monitoring 20 of notified bodies by competent authorities and a lack of requirements for medical devices without an intended medical purpose, to determine borderline 21 cases, and medical device classification issues. There was also a misalignment between the medical device regulatory framework and the new horizontal framework for product legislation. These were in part attempted to be remedied by exchange of views and coordination of activities of national competent authorities in informal and non-statutory working groups and the production of guidance documents. As the participation in the groups was voluntary and the guidance documents not legally binding, it was found that they are not suitable to enforce a high level of patient safety and the functioning of the internal market.

Problem 3 – Insufficient and incoherent data and information on medical devices

Due to the limited scope of the European databank on medical devices 22 (Eudamed 2) which was not publicly accessible 23  and the absence therefore of a comprehensive central database regarding medical devices available on the EU market, stakeholders, in particular users, claimed a lack in transparency. This prompted several Member States to impose registration systems both in terms of databases and introduce traceability requirements on economic operators, including the regional use of Unique Device Identification systems in some cases, in order to have more information on devices put into service within their territory. These national measures hampered the establishment a European level overview of CE (European Conformity) marked devices placed on the internal market and were in part incompatible with one another, not allowing traceability across borders and creating burdens for economic operators that had to comply with multiple sets of requirements when placing products on the markets of different Member States.

As a consequence of the three problems described above, the regulatory framework provided an uneven level of protection of the patients, users and public health. Moreover, it lowered the confidence in the CE marking which should guarantee the free movement of devices within the EU, and which is also recognised by several non-EU countries as proof of compliance with their own national safety requirements (Figure 2 – Consequences). Moreover, an underlying regulatory fragmentation in the system was also identified as a problem at the time. This could be understood as both a problem in itself, and as further compounding the above-described problems by hampering coordination and harmonisation of competent authorities for medical devices, which in turn disrupted the smooth functioning of the internal market and impacts the safety of devices in the market.

2.1.3.Objectives and expected impacts of the new regulatory framework (i.e. Regulations) 

Although significant issues were found with the Directives, the findings did not imply that the European medical device regulatory system was fundamentally flawed. As such, the Regulations adopted by the European co-legislators maintained the overall objectives of ensuring a high level of protection of health for patients and users and a smooth internal market, as well as providing a regulatory framework that supports innovation and competitiveness and fosters transparency on medical devices for citizens and actors (Figure 2 – General objectives) and built on the existing systems in place (Figure 2 – Specific objectives).

To achieve these objectives, the Regulations foresaw that financial, human and institutional resources would be inputted at Member State and European level (Figure 2 - Expected input) and that a number of actions would be put into place (Figure 2 - Expected output) across the lifecycle of a medical device/IVD to create a robust, transparent, predictable, and sustainable regulatory framework at European level. The regulatory framework to be established under the Regulations is described represented in Figure - Expected outputs and changes introduced across the device lifecycle in Figure 1. These changes range from strengthening already existing requirements (e.g. on clinical evidence) and incorporating existing elements that were previously not legally binding into the legal act (e.g. post-market surveillance), to introducing new elements into the regulatory infrastructure at European level (e.g. expert panels, EU reference laboratories, UDI, EUDAMED with six interconnected modules and some available to citizens/patients).

Nevertheless, some of the above changes to the regulatory framework come with inherent trade-offs. These trade-offs include the strengthening of requirements (e.g., clinical evidence or post-market surveillance requirements and notified body oversight), with expected increase in regulatory burden for most actors in the system; and increased harmonisation and reinforced governance systems, implying enhanced coordination and more resources. In this context, the Regulations contribute to the implementation of United Nations Sustainable Development Goals (UN SDGs) adopted in 2015 24 . In particular, it is expected that safe and performant devices contribute to SDG 3 and SDG 9. In materialising the expected inputs and outputs, the Regulations aim to achieve long-term impacts that are expected to be reached once the Regulations are fully implemented (Figure 2 - Expected impacts) and results that are expected to be reached in the medium-term, during the implementation of the Regulations (Figure 2 - Expected results).

Figure 1 - Lifecycle of a medical device/IVD (source: Technopolis 25 )

Figure 2 – Revised intervention logic

2.2.Point(s) of comparison 

Before the adoption of the Regulations in 2017, data on the EU regulatory system for medical devices and IVDs was limited and fragmented. Most available figures originate from the 2012 Impact Assessment with evidence gathered between 2006 and 2012. Due to the lengthy period between the intervention’s development and its gradual implementation, these data are indicative. They provide an approximate picture of the situation under the Directives and the conditions that motivated regulatory reform. This serves as a contextual baseline for assessing subsequent developments under the Regulations.

The point of comparison for this evaluation covers the period between the drafting of the 2012 Impact Assessment, when the Regulations were designed, and the start of their gradual implementation from 2017 onwards. It therefore spans a broader timeframe than a single reference year, reflecting both the situation under the Directives and the transition to the new framework. Taking into account the expected evolution in the absence of the intervention is not feasible due to the lack of consistent data and the long delay between policy design and implementation. In addition, the adopted Regulations differ significantly from the proposed acts, necessitating a cautious interpretation of the 2012 supporting impact assessment. Furthermore, the medical devices sector has been influenced by external factors including the COVID-19 pandemic and related global supply chain disruptions and changing patterns of medical consumption and innovation. Consequently, observed changes in key indicators (see Annex III) cannot be interpreted solely in quantitative terms. They require careful qualitative assessment of which developments can reasonably be attributed to the Regulations themselves.

Many stakeholders (e.g., healthcare professionals, patients, Health Technology Assessment (HTA) bodies, among others) indicated that the regulatory framework under the Directives lacked transparency 26 . It was particularly underlined that there was no access to data on several aspects, including medical devices’ characteristics, clinical data, and their conformity assessment pathways. In addition, Eudamed 2, at the time, was limited to some information on class I devices and neither the public nor healthcare professionals, had access. Furthermore, these safety crises occurring at that time had largely hampered the level of trust in the regulatory systems and devices in the political scene 27 .

Under the Directives, the designation, oversight and performance of notified bodies varied significantly across Member States. National authorities and manufacturers pointed to major differences in how notified bodies conduct conformity assessments – particularly in the depth and quality of their evaluation of manufacturers’ clinical evidence and in the use of tools such as unannounced inspections or product checks. Notified bodies themselves acknowledged such inconsistencies, which led to uneven levels of patient safety and distorted competition between manufacturers 28 . Furthermore, some evidence (e.g. surveys in the clinical technical working group) indicated an increase in pre-market clinical investigations following the 2007/47/EC amendments, which was potentially linked to reinforced requirements. However, comparable EU-wide data were not available, as some national competent authorities did not provide figures while others aggregated data for clinical investigations and IVD performance evaluations.

The EU market for medical devices under the Directives was characterised by a broader device availability and generally faster access to new technologies compared to other major markets. Studies at the time indicated that while EU patients could access innovative and complex devices several years earlier than U.S. patients, this advantage sometimes came at the cost of insufficient pre-market evidence and subsequent product withdrawals 29 . Despite these trends, comparable data on market entry timelines, device withdrawals, or competitive dynamics across Member States were limited, constraining the assessment of how far the Directives ensured a truly level playing field or balanced innovation with patient safety.

Before the Regulations, vigilance and post-market surveillance were fragmented and inconsistently applied across Member States, leading to significant variation in the detection and management of risks. Moreover, there were no consolidated statistics allowing for an overall assessment of device safety across the EU, and most incidents did not lead to regulatory measures, often due to insufficient investigation capacity 30 . As a result, the framework under the Directives provided only a partial picture of device performance and safety, limiting early detection of emerging risks and delaying coordinated responses at EU level.

3.1.Current state of play 

The MDR and IVDR entered into force in May 2017 and have been in application since May 2021 and May 2022, respectively. However, so far, implementing the Regulations has been challenging, resulting in the need to amend the transitional period for existing devices (see sections 1 and 3.2). Despite implementation delays, unexpected factors and some unintended effects of the Regulations, progress has been made in several areas.

3.2.Implementation progress

Unexpected factors: the COVID-19 pandemic prompted a one-year delay (with the exception of some provisions) in the MDR’s application 31 to allow authorities, health institutions and manufacturers focus on the unprecedented crisis to health systems and ensure supply of critical devices. These resource-intensive activities significantly impacted MDR implementation in the subsequent years, thereby indirectly affecting IVDR implementation from 26 May 2022 (see section 4.1.1.6). 

Unintended effects: as stakeholders have reported challenges in meeting strengthened requirements and capacity constraints, leading to the risk of shortages and disappearance of critical devices from the market (particularly niche and orphan devices for small populations), several transitional measures have been introduced (see also section 4.1.1).

Legislative (amendments): implementation challenges, exacerbated by the COVID-19 pandemic, led to unforeseen amendments to the Regulation's transitional provisions. The MDR transitional period was extended across all device classes (see Annex VII, Figure 7 and 8 32 ): to December 2027 for high-risk devices, December 2028 for medium risk devices. These extended transition periods were however subject to several conditions 33 . The legislative amendments also removed the sell-off period 34 for legacy devices. Similarly, the IVDR transitional periods were extended twice 35 , 36 , to December 2027 for high-risk IVDs, December 2028 for medium-risk IVDs, and December 2029 for lower-risk IVDs, under conditions akin to the MDR. Overall, this staggered approach by risk class aims to manage the workload on notified bodies, ensuring patient access to safe devices while mitigating the risk of shortages and minimising negative business impacts including on innovation. EUDAMED’s modules for mandatory use have also been gradually rolled out to mitigate the consequences of development delays 37 36. In addition, an advance warning mechanism for supply interruptions and discontinuations was introduced 38 (see section 4.1.1.3).

Legislative (implementing and delegated acts): under the Regulations, the Commission holds a significant number of empowerments for implementing and delegated acts 39 . Whilst not all have been exercised, they have so far proved an essential simplification tool to respond to progress in the fast-evolving medical devices sector and overall facilitate an efficient implementation of the Regulations. These include novelties of the MDR applying to products without a medical intended purpose (such as dermal fillers), and simplification measures, such as the possibility for healthcare professionals to also receive the manufacturer’s instructions for use in electronic format 40 , establishing expert panels on orphan devices 41 , as well as common specifications 42 . Planned measures include the expansion of the list of well-established technologies (WET) 43 and on the uniform application of requirements for notified bodies 44 . In addition, in October 2025, 38 harmonised standards (which provide manufacturers with a presumption of conformity to the requirements of the Regulations) are available (36 under the MDR and 17 under the IVDR). 45  

Governance and coordination: a number of coordination structures have been formalised or newly established 46 . At the European level (See Annex VII, Figure 1), the European Commission has regulatory, policy and audit responsibilities in coordinating the implementation of the Regulations. The European Commission’s Joint Research Centre 47 provides scientific support and coordinates the selection procedure for the EU reference laboratories (EURLs). The European Medicines Agency (EMA) 48 is involved in providing scientific and clinical support through expert panels 49 . At the national level, Member States have duly designated competent authorities 50 responsible for implementing the Regulations, who are also appointed to the Medical Device Coordination Group (MDCG) and its 13 technical sub-groups, chaired by the European Commission 51 . Finally, notified bodies 52 are third-party entities, either public or private, designated to carry out conformity assessment activities for medium and high-risk devices and issue relevant certificates. The Regulations have also established the Notified Body Coordination Group (NBCG-Med 53 ) to enhance notified body coordination in the de-centralised certification system.  

In addition, a pilot for the coordinated assessment of clinical investigations and performance studies across multiple Member States, supported by the European Commission was launched in February 2025 54 . Building on this, the COMBINE programme 55 looks at coordinated assessment of clinical investigations and performance studies, combined with clinical trials of medicinal products.

Scientific structures: expert panels 56  serve to provide scientific, technical and clinical advice relating to medical devices and IVDs, as well as provide opinions on clinical evaluation by notified bodies for certain high-risk medical devices and IVDs. In 2025, there are a total of 12 thematic panels for MDs and 1 for IVDs. For EURL designations, the first set of EURLs was designated in 2023 covering four categories of high-risk IVDs. In 2025 another call for EURLs has been launched in two waves 57 to cover additional categories.

Notified bodies & Conformity assessment: as of October 2025, the NANDO system lists 51 MDR-designated notified bodies and 19 IVDR-designated bodies, with 12 MDR and 6 IVDR designation applications pending (See further section 4.1.1.2).

Transparency and traceability: the Unique Device Identification (UDI) system 58  requires all Regulation-compliant devices to be assigned, labelled and registered in EUDAMED, with a unique alphanumeric code. Applicable to all device risk classes, this system ensures that devices are uniquely identifiable and traceable in the EU, enhancing safety monitoring and healthcare digitalisation 59 . In addition, the European Medical Device Nomenclature (EMDN) 60 , has been set up and provides a freely accessible nomenclature for use by manufacturers across compliance documentation and for EUDAMED device registration. It also serves various stakeholders like patients, researchers and practitioners, support transparency by providing key descriptions of devices available on the market and their categorisation. There have been delays in the development and mandatory use of the six EUDAMED modules 61 . EUDAMED aims to prevent multiple national registrations and to facilitate market monitoring. It is currently being developed in collaboration with the MDCG. Three modules have been available for voluntary use Actors (2020), UDI/Devices and notified bodies/Certificates (2021) which are being used by more than 85 000 users (manufacturers, notified bodies, public authorities, healthcare professionals, other actors 62 ). Along with the Market Surveillance module, they will be mandatory to use from 28 May 2026, with the vigilance module to be made available after and the Clinical investigations/Performances studies module still under development. 63

Non-legislative: Over 100 MDCG guidance documents have been published, and the Commission has funded numerous activities under the EU4Health Programme, to support the implementation of the Regulations. 64  These range from market monitoring activities, to enhancing certification efficiencies and supporting innovation, such as the ‘NoBoCap – (Notified Body Increased Capacity) and the horizon scanning projects 65 . Recently to address shortcomings in the system, the MDCG is also working on non-legislative short-term actions, such as guidance on breakthrough technologies, certificates under conditions and on orphan IVDs to facilitate more efficient implementation 66 .

The evaluation questions covering all evaluation criteria are presented in Annex III.

4.1.To what extent was the intervention successful and why? 

4.1.1.Effectiveness

A broad set of indicators were identified in relation to the general objectives of the Regulations. For the purpose of the analysis, they were grouped into five sections containing responses to several sub-evaluation questions (1) Legal certainty, transparency and trust; (2) Notified bodies, conformity assessments and clinical evidence; (3) Market functioning and level playing field; (4) Post-market surveillance and vigilance, and (5) Simplification and streamlined procedures. This grouping ensures thematic coherence and reflects functional linkages (e.g. notified body designation being linked to implementation of conformity assessment and clinical evidence requirements). Details on the grouping and scoring system used for each section are presented in Annex II, sections 2.2 and 3.2 and more detailed evidence for each section is presented in Annex VI scoring Tables 1 – 5 along with a final score per evaluation criterion in Annex VI scoring Table 6.

Legal certainty, transparency and trust

Legal certainty, trust, and transparency are closely interlinked – clear definitions and consistent application build predictability, while transparency tools provide the information base that supports both. At the time of the adoption, the Regulations were expected to deliver a high and uniform level of legal certainty, ensure transparency on medical devices for all actors and citizens, and strengthen trust among stakeholders. As of 2025, these objectives have been only partially achieved: while the legislative framework has enhanced clarity and consistency compared to the Directives, persistent gaps in implementation have limited predictability, transparency, and trust in the system (see negative score in Annex VI, Table 1). Perceptions of unclear requirements and divergent interpretations across Member States and notified bodies limit predictability and hinder the smooth functioning of the internal market. While the Regulations have laid important foundations for transparency and trust through public and stakeholder access to information, their full potential remains unrealised, and implementation poses challenges.

To what extent has the MDR/IVDR increased legal certainty for stakeholders (definitions, procedures, consistency of application)?

Evidence shows that so far fewer national legal disputes in which a court decision was taken have been reported under the Regulations (2018 – 2024) compared to the Directives (2014 – 2021). One Member State reported a particularly notable decrease in national legal disputes, from 77 under the MDD/AIMDD to just 2 under the MDR/IVDR. As for disputes between manufacturers and notified bodies on device classification, few national decisions have been reported respectively under MDR (23) and IVDR (3) across 9 countries, with outcomes being split between manufacturers and notified bodies opinions 67 . For medical devices, this can be compared to 167 decisions reported across 11 countries under the MDD/AIMDD from 2014 – 2021. However, no causal link can be inferred between the number of legal disputes and legal certainty; fewer disputes may result from other factors, such as greater awareness of reporting mechanisms or external factors, such as cost of legal disputes and timelines for decisions in particular legal systems.

The guidance volume under the Regulations is high, with over 100 MDCG guidance documents & FAQs 68 issued since 2017 which were expected to facilitate implementation. Stakeholders have however reported on-going challenges with clarity and consistency in the Regulation’s implementation, including unclear definitions, inconsistent interpretations by notified bodies and national authorities and vague or impractical guidance 69 . Only 40% of public consultation respondents believe MDCG guidance brings legal clarity 70 and 112 out of 324 stakeholders responding to the Call for Evidence called for clearer, binding guidance and stronger alignment across Member States to reduce ambiguity and ensure predictability 71 . Evidence therefore suggests that operational legal certainty remains limited.

The Regulations introduced various EU level procedures including on classification disputes and product qualification, aiming to enhance legal certainty 72 . So far, these procedures have not been used. Furthermore, implementation experience of non-binding procedures has shown ineffectiveness. For instance, the ‘Helsinki procedure’ to determine borderline and qualification issues 73  is too lengthy (average duration 347 days) 74 , due to insufficient human resources and the lack of mandatory outcomes leading to low Member State participation in coordination. The qualitative evidence suggests that, while the Regulations have improved the legislative framework, operational clarity and harmonisation remain insufficient. Overall, increased consistency in interpretations and application of the Regulations by actors across Member States, as well as targeted improvements 75  are needed for the Regulations to realise their full potential for legal certainty and support a smooth functioning of the internal market.

To what extent have the Regulations improved transparency for stakeholders?

The Regulations have introduced several public information requirements and tools to improve transparency on medical devices. Information at EU level has increased through EUDAMED, providing for the first time a centralised EU data repository on economic operators, devices, and UDI registrations, as well as public access to reports. Although it was projected in 2017 that EUDAMED would be fully operational and mandatory between 2022 and 2024, implementation remains incomplete, its data accessibility and usability—and thereby transparency—are still limited for economic operators, healthcare professionals, patients, and users. This stems primarily from the gradual implementation process rather than the design of the regulatory framework.

EUDAMED public information and traceability mechanisms have been introduced to improve device safety monitoring and align with technical progress. These include requirements for manufacturers to publish Summaries of Safety and Clinical Performance (SSCPs) for high-risk and implantable devices, and for national designating authorities of notified bodies to publish summaries of monitoring reports. Publication should occur in EUDAMED once relevant modules are available for mandatory use. So far, compared to expectations in 2017, SSCP publication rates (by other means) appear low 76 , whilst most countries with MDR/IVDR notified bodies have published summary monitoring reports 77 .

On traceability, the UDI system will allow devices to be uniquely identifiable, traceable and monitored throughout the life cycle. It will provide a complete overview of devices on the Union market and safety information for users. Until UDI is fully applied to all devices on the market 78 , the benefits of the system cannot yet fully be realised. Stakeholders welcome the UDI system, as an important step towards traceability, though 22 out of 121 of respondents noted challenges in its governance, rigidity, and delayed implementation 79 . In this regard, experience with UDI implementation experience has shown a need for adaptations in the system, particularly to accommodate identifications solutions for highly individualised devices 80 . Flexibility for future such accommodations could be considered.

The gradual rollout 81 of EUDAMED the key tool to facilitate enhanced transparency and traceability requirements is progressing (see section 3.2. Implementation progress). Although data remains incomplete until EUDAMED’s mandatory use, centralised public information on devices, i.e. the number of devices, certificates and actors registered has increased. Stakeholders identify the lack of a fully operational EUDAMED as a central obstacle to transparency, with its completion and improved functionality being a top priority 82 . They also pointed to the resulting limited access to public information and incomplete share of data, thus highlighting the gaps in transparency 83 .

Overall, in terms of the Regulations achieving transparency and traceability objectives stakeholder perceptions remain mixed. Whilst these objectives are widely supported, frustrations persist about the lack of usable outputs in the regulatory system so far. More than 75% of public consultation respondents disagreed and strongly disagreed that a “robust, transparent, predictable and sustainable” regulatory framework exists 84 , citing limited SSCP availability and non-transparent notified body processes. On the same note, healthcare professionals highlighted insufficient transparency in clinical data 85 , and on notified body processes, including unclear timelines and fees 86 83. Stakeholders show broad support for enhancing transparency and traceability through EUDAMED, UDI, and public access to clinical data, recognising the importance of these tools even though evidence on their impact remains limited 87 . Patients’ perspectives in addition, were positive with over 65% of respondents to the Public Consultation agreeing they have access to information on devices and their use 88 .

To what extent have the Regulations increased trust of patients, professionals, and industry in the EU regulatory system?

In 2017, the Regulations introduced strengthened safety requirements to the EU medical device regulatory framework with expectations to rebuild confidence and address concerns that emerged from safety crises under the Directives 89 . However, today the level of trust in the system remains low. Qualitative evidence shows that despite progress, implementation inconsistencies, limited transparency, and procedural inefficiencies continue to undermine confidence in the system. While there is no pre-Regulation baseline data available to assess how trust has evolved, stakeholder feedback reveals persistent uncertainty and scepticism.  

Although no major safety crises have occurred since the introduction of the Regulations, confidence in the system varies widely. Public consultation responses show that less than 20% of participants believe that the Regulations significantly contribute to trust in the regulatory system (economic operators being the most sceptical group, followed by national competent authorities and healthcare professionals 90 ). Other findings from the governance study survey echo those differences: 71% of consultants and notified bodies perceive an increase in trust, while only 46% of economic operators and trade associations share this view 91 . Qualitative evidence reinforces these trends, describing a lack of trust linked to regulatory complexity, inefficiencies in the way the system operates, uneven application across Member States, and divergences in interpretation 92 .

18 out of 87 respondents to the Call for Evidence link trust to greater transparency, safety, and accountability, suggesting that while trust is low, it can be rebuilt through clearer, harmonised, and evidence-based regulation 93 . One healthcare provider explained that a transparent regulatory system is central to building trust in the use of devices, giving the example of the need for publicly shared and easily accessible clinical evidence 94 . Whilst not yet achieved, the level of trust in the system could increase once the Regulations are fully implemented and are interpreted and applied in a consistent manner, with improved device transparency and more operational efficiency.

Notified bodies, conformity assessment procedures and clinical evidence

The Regulations are based on the New Legislative Framework 95 , which relies on the conformity assessment of products. For medium and high-risk devices, the involvement of a notified body in the conformity assessment is mandatory before CE-marking and thus allowing the placing on the market. Given the fundamental healthcare role of medical devices and IVDs, the Regulations sought not only to ensure the smooth functioning of the internal market, but also to increase patient safety by enhancing the pre-market requirements for devices, including the generation of clinical evidence. Thus, in 2017 the Regulations were expected to ensure a consistent and effective designation and oversight of notified bodies across the EU, streamline conformity assessment procedures, and strengthen clinical evidence requirements. Overall, the notified body designation and oversight remain uneven, conformity assessment processes are perceived as unpredictable and inefficient (see negative score in Annex VI, Table 2). Whilst notified body capacity was initially insufficient under the Regulations, MDR-designated notified bodies have now reached a comparable capacity to under the Directives, whilst for IVDR, it remains to be determined. Although a level fragmentation can be expected in a decentralised certification system, the increased harmonisation in conformity assessment activities by notified bodies sought under the Regulations has not yet been achieved, partially due to divergent interpretation of requirements and oversight capacity of notified bodies by authorities. Finally, clinical evidence requirements have been enhanced 96 (though stakeholders question their proportionality for low and medium risk devices, see section 4.1.2). However, judging the quality and availability of clinical evidence and the correlation to improving device safety remains challenging due to the on-going implementation of the Regulations.

To what extent are notified bodies designated and overseen effectively and consistently across the EU?

In the first years of application of the Regulations, the number of designated notified bodies was insufficient to respond to certification demand for both legacy devices (transitioning from the Directives to the Regulations) and new technologies. This bottleneck can be partially explained by the initial long designation timelines, which have however experienced a positive evolution over time. Indeed, whilst designation now averages at 1041 days (median: 1022 days) for MDR and 1166 days (median: 1296 days) for IVDR, this has been decreasing overtime (the latest notified bodies to apply and achieve designation took 745 days for MDR-designation and 686 days for IVDR-designation) 97 (see Annex VII, Figures 3 & 4). In addition, the large variation in the number of days spent across designation milestones shows poor harmonisation of the process. The two longest steps of the designation process are the on-site checks of corrective plans by the notified body, which are approved by the authority 98 , with a median of 245 days for MDR, 194 days for IVDR, and the Joint Assessment Team’s 99  (JAT) delivery of its opinion on the corrective plan to national authority’s decision, with a median of 197 days for MDR and 134 days for IVDR (see Annex VII, Figure 5). These two longest steps are entrusted to the designating authority and the notified body, and do not involve the JAT which includes both Commission and national experts.

Moreover, most non-compliances raised during the designation of notified bodies relate to process and resource requirements, affecting designation length, and the number raised varies significantly among Member States. This indicates additional variation in national processes and the difficulty for notified bodies to meet such requirements. In addition, even though the joint assessment process is intended to bring consistency and a harmonised approach to designation, the number of national experts participating in it does not necessarily correlate to the number of notified bodies in a country.

The number of notified bodies under the Regulations has increased significantly over time after, an initial delay 100 (see Annex VII, Figure 6). Consequently, stakeholders no longer view notified body capacity as a main problem for medical devices. However, for IVDs, despite the positive evolution in the number of IVDR-designated notified bodies, a greater proportion now require notified body involvement in conformity assessment than under the Directives. Numbers are expected to further increase with 12 MDR and 6 IVDR designation applications on-going 101 . In terms of the designation scope for notified bodies (i.e., device types they are authorised to certify 102 ), notified bodies have obtained 92% of medical device codes and 97% of IVD codes that they applied for 103 . However, medical device codes are not always evenly spread among notified bodies, with low coverage codes generally concerning highly complex devices requiring specialised expertise (e.g., active implantable medical devices). Capacity to certify different device types therefore may vary. Difficulties for notified bodies in obtaining all desired codes, may be linked to stricter resource requirements under the Regulations, where non-compliances are often raised. Whilst scope extension requests are possible after initial designation, (with 3 of 9 requests under the Regulations to date completed), the process is burdensome requiring a repeat of the whole designation process to achieve the extension.

National designating authorities independently perform notified body oversight, through on-site audits, review of personnel files and technical file assessment without any direct central oversight. Coordination takes place at EU level through the MDCG, the subgroup for notified body oversight (NBO 104 , with 21 meetings, 29 MDCG-endorsed documents 105 ), the Notified Body Coordination Group (NBCG-Med, with 12 meetings, 3 documents) and via information sharing (national designating authority annual reports). Despite growing national monitoring activities and EU coordination efforts, the level of coordination of notified body oversight remains insufficient. Stakeholders often cite differences in interpretation and application of notified body requirements as a source of fragmentation and unpredictability in the system 106 .This is due to varying procedures by different designating authorities, leading to diverse monitoring outcomes and ultimately, a lack of harmony in the activities of notified bodies across the Union.

To what extent are conformity assessments carried out effectively, predictably and consistently?

Whilst the number of designated notified bodies and full-time equivalent (FTE) staff have increased, insufficient data on certification demand makes it difficult to determine whether resources are sufficient and used efficiently. Over 1 500 FTEs (>30%) are dedicated to administrative and supporting tasks, which are not related to core conformity assessment activities 107 . The issuance of a new certificate takes 6-18 months (Quality management system (QMS) only) and 13-24 months (QMS and product) in most cases, and certification time is almost evenly attributable between the manufacturer and the notified body. 108  In terms of application processing, notified bodies often cite poor application quality and manufacturer preparedness as reasons for refusals.  The vast majority of refusal of applications was due to ‘outside scope of notified body’s designation’ (631/1,149 or 54.9%), followed by ‘application not complete’ (179/1,149 or 15.6%) and ‘wrong qualification of product/classification of device’ (148/1,149 or 12.9%) 109 . Finally, of notified bodies using structured dialogue 110 (i.e., exchanges of technical and regulatory information between the notified body and manufacturer to facilitate the application process), 75.7% estimated less than a 25% reduction or no reduction in the length of the conformity assessment. Conversely, early dialogue is often cited by stakeholders as a key tool for planning and developing clinical investigations 111 .

There has been a negative evolution in the perceptions among economic operators on the level of harmonisation of notified bodies’ conformity assessment activities 112 , with respondents more likely to disagree that they are more harmonised under the Regulations than the Directives. One example of this issue is the inconsistency in how notified body fees are presented. Although all notified bodies make their fees publicly available 113 , most do not adhere to the template list of standard fees established by the MDCG, which hampers the formation of a level playing field across Member States.

To what extent have requirements for clinical evidence improved device safety and performance?

The number of clinical investigation applications has remained steady throughout the years, with the proportion of granted (~85%) versus denied (~15%) also remaining stable 114 , with however, significant variation in the number received per country. Stakeholders have raised this and called for a central structure for coordination of multi-national clinical investigations, and enhanced transparency and accountability 115 . In addition, the number of clinical investigations for research purposes, post-market clinical follow-ups (PMCFs) and performance studies have all increased 116 . This demonstrates that pre-market research & development continues to take place, and an increasing level and quality of clinical data may support the making available of new devices.

Moreover, to support the generation of quality clinical data, new structures for scientific oversight have been established and their use is steadily increasing every year, with 77 Clinical 117 and Performance procedure 118 submissions to expert panels in 2024 alone and 31 opinions issued since their inception. However, stakeholders have highlighted that these consultation procedures alone are not sufficient for developers. Indeed, early dialogue with regulators and notified bodies, and the possibility to get clear guidance at an early stage (i.e., regulatory advice) are often cited as potential approaches that would allow developers to shape their clinical investigations and evidence generation strategies more effectively to meet regulatory requirements 119 , 120 , particularly for highly innovative medical devices and IVDs. The notion that developers struggle with preparing regulatory documentation, is supported by the notified body survey, where 71.2% of respondents reported over 50% of clinical evaluation reports (CERs)/ performance evaluation reports (PERs) they receive are incomplete or inaccurate, and 52.5% indicated over 75% are incomplete or inaccurate.

Furthermore, in terms of access to clinical evidence, most clinical investigation and performance study reports and their summaries (SS(C)Ps) are not made public (see section 4.1.1.1). Consequently, healthcare professionals, patients and users’ perceptions are that clinical evidence may be increasing, but its availability and their access to it remains low, thus hampering patients and users’ ability to make informed decisions on devices.

Market functioning and level playing field

The availability of devices, fair competition, and global competitiveness of the EU industry are essential for market functioning and ensuring patients’ access to devices that meet their needs. In 2017 when the Regulations were adopted, they were expected to enhance competitiveness, foster innovation, and as a result, maintain broad device availability across the EU. To date, these objectives have been only partially achieved: while the regulatory framework has increased oversight and safety of devices, its complexity and uncertainty have constrained innovation and competitiveness, particularly for SMEs (see negative score in Annex VI, Table 3). This has resulted in longer timelines and limited device availability, notably affecting niche and orphan devices where limited profitability and high compliance burdens have led to portfolio reductions and market withdrawals.

To what extent have the Regulations affected competitiveness and innovation of EU industry?

The European market of medical devices is estimated at 170 bn EUR in 2024, making it the second largest after the United States (US) 121 . The European medical device sector has demonstrated steady growth since 2017, with an average of 6% per year for medical devices and 4.3% for IVDs over the past decade, measured in terms of manufacturer prices 122 . This expansion, however, does not necessarily mean a proportional increase in innovation and competitiveness. Instead, it likely reflects broader market expansion and rising demand.

The EU remains the second leading originator of patents worldwide in the medical devices sector, following the US 123 . Patents granted increased by 29.5% between 2017 and 2024 and the number of patent applications increased by 19% over the same period, showing a slight increase in the overall patents approved 124 . The steady patenting performance, together with the EU’s strong export position 125 , indicate a continued capacity for innovation, commercial attractiveness and research and development investment 126 . However, evidence of this on the market is not yet apparent.

In the international setting, the EU’s bilateral and multilateral activities have continued under the Regulations. The EU has strengthened its role in the International Medical Device Regulators Forum (IMDRF) 127 , with the European Commission and 8 Member States being involved in all working groups 128 and continued implementation of IMDRF guidance 129 . While the number of bilateral operational agreements has declined since 2017, progress includes updates to the EU – Turkey Custom Union for medical devices 130 . Despite continued reliance on EU MDR/IVDR certificates by other jurisdictions (125 for medical devices, 45 for IVDs 131 ), implementation challenges have reduced their exclusive use, with new reliance frameworks emerging. The EU’s observer role in the Medical Device Single Audit Program (MDSAP) 132  – where 13 EU designated notified bodies also act as Auditing Organisations and over 1 600 MDR and IVDR certificates have been issued through combined audits 133  – illustrates its ongoing engagement. Should the EU decide to take a more prominent role in MDSAP, this would allow further convergence, process simplification and international competitiveness. 

Stakeholders express caution about the Regulation’s impact on innovation. In the public consultation a large majority of stakeholders strongly disagreed that the Regulations contributed to innovation 134 . In the governance study survey, 60% of stakeholders indicated that MDR does not stimulate the introduction of highly innovative devices on the EU market, while 48% share this view for IVDR 135 . Such perceptions are particularly critical for SMEs and start-ups, which often face higher relative compliance costs and limited resources to navigate lengthy conformity assessment processes. Innovation and first market entry are increasingly shifting to other regions, particularly the US where regulatory pathways are seen as more predictable, faster, and less costly for SMEs 136 . While the EU market remains large and resilient, the regulatory framework is perceived as a significant barrier to enhanced innovation and competitiveness. Stakeholders point to the need for specialised regulatory pathways for innovative devices to ensure their availability 137 and highlight the need to develop structured, harmonised early scientific and regulatory dialogue frameworks. 138

To what extent have the Regulations ensured a level playing field for economic operators across the EU?

The Regulations have introduced a strengthened and single EU regulatory framework for ensuring device safety and performance, yet discrepancies in the application of requirements across notified bodies and Member States have led to uneven compliance practices, affecting costs and timelines and disproportionately impacting SMEs. A majority of consulted stakeholders 139 stated that inconsistencies in the interpretation, implementation, and costs of the Regulations across Member States and notified bodies create an uneven playing field. In the conformity assessment process, fragmented practices notably by notified bodies and designating authorities (see section 4.1.1.2) have led to a lack of predictability of the processes and have hampered the Regulations’ objective to ensure an even playing field. To address these challenges and restore confidence in the regulatory framework, stakeholders call for greater EU-level harmonisation of application of requirements, reduction of costs, and cost-efficiency of procedures 140 . Healthcare professionals, insurers, and EU bodies advocate for more centralised processes and fees 141 .

To what extent have the Regulations affected the availability of devices on the EU market (shortages, withdrawals, delays)?

Although it would have been expected in 2017, similar to under the Directives, comprehensively determining the number of medical devices available on the EU market is not yet possible. For this, full implementation of UDI and complete registration requirements in EUDAMED are needed. For the number of devices, the lack of reliable baseline data makes it challenging to estimate the portion of devices that may not transition to the Regulations, or that if discontinued, would be deemed unacceptable. Moreover, device availability is also influenced by broader economic factors, such as supply chain disruptions and demand fluctuations. It is therefore not possible at this stage to credibly estimate the extent to which the Regulations alone have affected device availability.

The number of applications lodged by manufacturers and certificates issued under the Regulations is however monitored. Data collected between February 2021 and October 2024 shows that the number of applications and certificates has steadily increased 142  (applications filed under MDR: 28 069 and IVDR: 2 201; certificates issued under MDR: 10 554 and IVDR: 1 273), with the number of certificates issued begin comparable to that under the Directives 143 . Transition progress remains uneven as 14/50 notified bodies stated that fewer than a quarter of their clients have completed the MDR-certification for all intended devices and an equal share indicated completion rates above 75% 144 .

Recent evidence shows that so far, few notifications on interruptions or discontinuations in device supply with a patient or public health risk 145 have been made under the prior notification obligation for manufacturers (Article 10a) applicable since January 2025 146 . Whilst Article10a is facilitating oversight for authorities on the root causes of supply issues, improving information to the downward supply chain and shortage management in non‑crisis situations, predicting potential shortages and their impact on healthcare systems remains difficult. Enhancing synergies with existing monitoring systems, such as the EMA’s reinforced role in crises preparedness and management of medical devices 147 , could further improve governance in the emerging area of medical device shortage management.

As for stakeholder perceptions on availability and potential shortages, they vary considerably. Manufacturers are most likely to raise concerns on reduced availability 148 , with recurring reasons 149 for discontinuing certain devices including “revenue not justifying approval”, “products with low sales volumes”, “low profitability”, or “products at end-of-life cycle” 150 . At the same time, healthcare professionals broadly confirm difficulties in maintaining supply: almost 60% have faced shortages in the past 3 years, and 61% of European hospital pharmacists report shortages in their hospitals 151 . Although citizens are least likely to indicate problems 152 , it was underlined that shortages have adverse consequences for patient care, with disproportionate effects on vulnerable groups such as children, patients with rare diseases, and those requiring non-standard sized implants 153 . Overall, despite recognising the Regulations’ stricter requirements, stakeholders critique inefficiencies, delays, and lengthy procedures resulting in disproportionately high costs particularly for SMEs, orphan devices, and low-risk products 154 , thus impacting market availability.

In this context, and especially for orphan devices which are critical for patients with limited treatment alternatives, stakeholders consistently highlight the risk of discontinuations (see Annex V), with over half of manufacturers having planned portfolio reductions 155 . In 2024 only 52% of manufacturers intended to transfer their orphan devices to the MDR, while 29% planned none, and 26% would transfer less than 5% of IVDs 156 . These findings align with broader stakeholder perceptions. A majority indicated in the governance study survey that the Regulations contribute little or not at all to the availability of niche or orphan devices, with national competent authorities, health institutions, and patient organisations being especially critical 157 . Overall, 132 out of 393 stakeholders reported disproportionate impacts on SMEs and niche products 158 , confirming market pressures and compliance costs continue to threaten the availability of orphan devices 159 . To address this challenge, in addition to clarifications in an MDCG guidance 160 and an orphan device support grant 161 , the EMA has launched a pilot programme to support the development and assessment of orphan medical devices 162 . Stakeholders underline however the gap in dedicated regulatory pathways 163  in order to secure a sustainable supply of orphan devices, which could be further explored.

To what extent do the Regulations address specific needs of patients and users (e.g. rare diseases, paediatrics, accessibility)?

Though not expected in 2017, the implementation of the Regulations has created challenges regarding the availability of devices for patients with specific needs that prevent the objective of ensuring a high-level of protection of patient health and safety from being fully achieved in practice. For example, the Regulations introduced minimum conditions to regulate in-house devices manufactured and used within health institutions (as compared to the Directives), however their implementation has proven challenging. A majority of consulted stakeholders explicitly highlight documentation, validation, and equivalence requirements as overly burdensome 164 and 22 out of 124 stakeholders further flag difficulties in transferring in-house devices. A smaller share call for national-level regulation instead of EU oversight 165 . Due to the high regulatory burden, 75% of such tests were estimated in one evidence source by stakeholders to be discontinued 166 . In-house devices are an important category in the field of IVDs and public health laboratories also stress their importance for crisis preparedness, given in-house devices assay rapid diagnostics respond to novel pathogens or variants. Although data on the number of in-house-devices and health institutions is scarce (due to fragmented national records and no EU-level registration), one large university hospital reported that about half of its IVDs are in-house devices, with 70% having no market alternatives 167  .

To address specific needs, the Regulations also provide for the possibility to grant a derogation from conformity assessment for a device under specific circumstances, based on a patient or public health need 168 . Since the application of these provisions in 2020 (MDR) and 2022 (IVDR), the national derogation procedure has been frequently used (750 MDR and 49 IVDR derogations granted) but the EU-wide mechanism has only been used once. Whilst this mechanism helps meet patient needs, inefficiencies arise from multiple derogations being granted across Member States for the same device and manufacturer, 169  indicating the number of devices benefitting from derogations is lower than reported. This may indicate the need for an adapted streamlined process, based on scientific evidence (for example, using expert panels), to improve device availability and meet patient needs in situations of urgent health and safety.

In the public consultation, 46% of respondents agreed that the MDR contributed to protecting the health of patients in relation to medical devices (44% for IVDR), while 40% agreed that it contributed to protecting the health of users (35% for IVD) 170 (see Annex V). These gains must be weighed against implementation challenges, particularly for SMEs and manufacturers of niche and orphan devices.

Post-market surveillance, vigilance and market surveillance

The post-market surveillance, vigilance and market surveillance systems under the Regulations were expected to provide stronger and more coordinated mechanisms for detecting and addressing risks across the EU. To date, these objectives have been largely achieved, with clear progress in coordination among national authorities and improved reporting and oversight, resulting in increased device safety monitoring capacity (see positive score in Annex VI, Table 4). However, remaining inefficiencies and resource limitations at both EU and national levels, combined with the on-going implementation of the Regulations, mean that the full potential of the system is not yet realised.

To what extent has post-market surveillance and vigilance improved the detection and management of risks?

The Regulation’s strengthened provisions aim to protect health, patient safety and public health by facilitating the availability of comprehensive safety information and enhancing post-market safety coordination. Three interlinked and reinforced systems were established: (a) post-market surveillance, where manufacturers continuously monitor devices after market placement (b) vigilance, where manufacturers report incidents (which national competent authorities evaluate) and conduct field safety corrective actions; and (c) market surveillance, where national competent authorities oversee and control devices on the market. These systems involve all supply chain actors, including manufacturers, importers and distributors, national competent authorities, notified bodies, healthcare professionals, patients and other users of devices. Overall, citizens agree that devices are sufficiently monitored (76.5%, 0 disagree), and stakeholders agree that safety issues are adequately identified and addressed (74.1%) 171 . Nevertheless, there is mixed awareness on how to report incidents by healthcare professionals, with only 46.9% agreeing that they are informed on where to report an issue with medical devices, and none agreeing when it comes to IVDs.

With regards to post-market surveillance and vigilance, a general increase can be observed in reporting activity by manufacturers. Between 2022 and 2024, medical device serious incident reports (MIR) have increased over 20%, periodic safety reports (PSR) over 30%, and field safety corrective action (FSCA) reports about 1% 172 . Nevertheless, evaluating the effectiveness of the Regulations in ensuring a high level of health protection in the post-market context is complicated by the predominance of devices that were already placed on the market under the previous regulatory framework (legacy devices). Therefore, whilst the increase in reporting reflects an increased capacity to detect and potentially manage emerging safety risks, it remains challenging to assess whether any evolution observed reflects changes in device safety or only on reportability. Conversely, most economic operators indicated that the number of MIRs they submit to national competent authorities has not increased under the Regulations compared to the Directives and that no MIRs have led to a FSCA 173 . This discrepancy with the figures provided by national competent authorities may be explained by either a low number of manufacturers providing a significant proportion of the increased numbers of reports, or by potential differences in how reporting numbers are interpreted by manufacturers and authorities.

With regards to market surveillance activities by national competent authorities, the number of product samples controlled has seen an over eight-fold increase since the application of the Regulations 174 . In addition, the overall number of exchanges on device compliance between authorities (compliance exchange forms (CEFs) sent), have increased over 25% since the application of the Regulations, which is a positive indication for increased coordination on safety issues on the market. Moreover, for areas where market surveillance activities have not increased, evidence shows that activity has remained steady. For example, the number of proactive and reactive on-site inspections has not changed since the application of the Regulations, with less than a quarter of national inspection reports having a corresponding final inspection report 175 . Experience with market surveillance enforcement measures is beginning, though data so far is limited.  

Therefore, whilst under the Directives the obligations and empowerments for national competent authorities on market surveillance were significantly less developed, the above shows a positive increase in device safety monitoring capacity in the system. Owing to the short implementation timeline of the Regulations, it is difficult to judge the effectiveness of the market surveillance system at this stage. Nevertheless, this enhanced device safety monitoring capacity is anticipated to improve the ability to detect and address potential safety issues as they emerge.

Finally, whilst informal cooperation mechanisms existed under the Directives, the Regulations introduced coordination and cooperation obligations of vigilance and market surveillance activities by national competent authorities, to ensure a harmonised and high level of safety enforcement for devices. These have started to increase. For vigilance, there have been 149 coordination exchanges between national competent authorities. For market surveillance, competent authorities have formed three task forces to address device-specific safety issues and are participating in two joint actions 176 , 177 . Whilst joint actions are proving a useful tool to improve harmonisation of market surveillance, the evaluation has identified a lack of stable mechanisms to sustain this high level of harmonised surveillance. Notwithstanding this, coordination is expected to improve once the necessary tools are available, with EUDAMED’s Market Surveillance module scheduled for mandatory use from 28 May 2026 and the Vigilance and Post-Market Surveillance module to follow.

Simplification and streamlined procedures

Whilst the Regulations were expected to result in simplified administrative processes and a more efficient use of resources through higher levels of harmonisation and coordination at European level, the evaluation reveals shortcomings, particularly with regards to simplification and streamlined procedures (see negative score in Annex VI, Table 5). In general, two types of complexity have been observed: (a) complexity that undermines effectiveness e.g., unclear responsibilities, complex coordination mechanisms, unpredictability in decisions; and (b) complexity that undermines efficiency e.g., redundant reporting, duplicated oversight, administrative burden (see section 4.1.2). Both types of complexity result in a reduction of effectiveness and efficiency, respectively.

Regulatory structure and coordination: The regulatory governance framework of the Regulations (see section 3.2) is defined by two primary characteristics: a multi-tiered system and decentralisation 178 . Intensive coordination has been needed between EU level actors to operationalise the regulatory infrastructure and play their role effectively. As for coordination between the EU level actors and Member States, ineffectiveness has been observed in the MDCG framework, where the high number of technical sub-groups can lead to duplicative discussions or work, resulting in varied outcomes. In addition, sub-group output is agreed by consensus, which has caused delays in delivering requested clarifications on the Regulations for stakeholders. Furthermore, national designating authorities 179 are tasked with notification and oversight of notified bodies.

This complex governance system has resulted in increased staff time, frequent coordination meetings, and duplicated monitoring or reporting at different levels. Only 28% of surveyed healthcare institutions, professionals or patient organisations, and 35% of economic operators or trade associations, agreed that the regulatory governance structure and the way of working are clear 180 . Moreover, only 32% of healthcare institutions, professionals or patient organisations, and 34% of economic operators or trade associations, agreed that collaboration among actors is good 181 . Furthermore, only 33% of both national competent authorities and economic operators or trade associations, and 36% of healthcare institutions, professionals or patient organisations, agreed that most issues with the governance structure were temporary and were likely to subside within the following 2-3 years 182 . Examples of governance hurdles cited included perceived ineffectiveness in establishing EUDAMED, monitoring device availability, supervision and coordination of safety issues, and the publication of harmonised standards and common specifications, among others. 

Predictability and proportionality: the regulatory system’s perceived unpredictability was cited as a source of concern 183 . First, stakeholders call for increased harmonisation and coordination of practices among national competent authorities, national designating authorities and notified bodies (and between them). Second, as discussed in sections 4.1.1.1 – 4.1.1.4, lack of clear notified body processes, feedback and overall certification timelines are cited as sources of unpredictability, with early dialogue often presented as a potential solution 184 . Third, resource-intensive unannounced audits by notified bodies, lengthy timelines for consultation of other regulatory authorities, for example in the case of drug-device combinations (e.g. medicines authorities) or where relevant authorities for substances of human origin and cells and tissues of animal origin, and uncertainty on notified body approval of (significant) changes, are all highlighted as concerns.

Unpredictability is often combined with a perceived sense of disproportionality of requirements, particularly for clinical evidence of low- and medium-risk device manufacturers 185 . Though some devices can be exempt from certain Regulation requirements by achieving well-established technology designation, this list currently contains only 12 technologies 186 and has not been expanded since the Regulation’s introduction. In addition, the involvement of notified bodies in the conformity assessment of devices that did not require them in the past, such as class B IVDs was cited 187 as disproportionate compared to the risks of the devices. The Regulations are often perceived as lacking the necessary flexibility to provide adapted regulatory pathways for devices of niche or orphan populations, 188  causing health institutions, healthcare professionals and associations to express concerns about their continued availability (see section 4.1.1.3). 

Administrative burden: less than 20% of public consultation respondents agreed that administrative compliance costs are acceptable and will decrease after full implementation of the Regulations, regardless of the specific activity and Regulation consulted 189 . Stakeholders often stress duplication and overlapping of post-market surveillance and vigilance reporting requirements as sources of unnecessary administrative burden for economic operators. This includes duplicated assessment of vigilance reports by notified bodies and national competent authorities. 28 responses to the call for evidence indicated that in their opinion, post-market surveillance requirements were overly burdensome and disproportionate, with recurring themes including critiques of excessive documentation, redundant reporting, and disproportionate requirements for low-risk devices or well-established technologies 190 . Additionally, one fourth of public consultation respondents (namely manufacturers) indicated that, upon review, some of the serious incident reports (MIRs) they submitted did not meet the vigilance requirements 191 . Administrative burden can also be observed both in one-time registration of devices and maintenance of economic operator or ‘actor’ registrations in EUDAMED, along with recurrent reports, such as Periodic Safety Update Reports (PSURs), which are updated either annually or bi-annually depending on device risk-class.

Digitalisation: increasing access to digital technology and the expansion of advanced technologies have revealed some shortcomings with the level of digitalisation allowed by the Regulations. For example, a survey for healthcare professionals on the use of electronic instructions for use (e-IFU) 192  revealed that 88% of respondents prefer e-IFUs compared to the paper version, a solution that has now been implemented 193 . In addition, 61% of respondents agreed that e-IFUs should be expanded to all medical devices, with a further 29% supporting a limited expansion to devices where a healthcare professional trains the lay user. As a result, the Commission has allowed the use of e-IFUS for all devices intended for professional users and devices without an intended medical purpose 194 .

Other potential areas for digitalisation include labelling information not critical to safe device use, using compliance tools to digitally capture information currently contained in multiple documents and reports (such as the EU declaration of conformity), or electronic submission systems for information and documentation related conformity assessment. Furthermore, once UDI and EUDAMED are fully in place, they will enable further digitalisation of device information and help health providers with traceability of devices.

Internal and external factors that have contributed to or hindered the progress towards the objectives of the MDR and IVDR

Externally, the COVID-19 pandemic had significant and lasting impacts on the implementation of the Regulations. The pandemic delayed both MDR and IVDR transitions and disrupted audits, performance studies, and laboratory operations under the IVDR. Significant resources were also diverted from the regulatory transition in authorities, to ensure the safe development and availability to EU citizens of essential devices such as COVID-19 tests, and ventilators and masks. 195  

Internal factors relate primarily to the functioning of the governance structure and allocation of resources. The Regulations introduced new coordination systems, notably through the MDCG, which has strengthened cooperation and information sharing between the Member States and the Commission. However, the consensus-based working methods have proven resource-intensive and slow, with lengthy processes for developing guidance documents and achieving harmonised approaches. Overall, while the governance system has improved cooperation, limited resources, complex coordination, and uneven implementation continue to hinder efficiency and the overall progress towards the final objectives of the Regulations.

4.1.2.Efficiency

Annex IV synthesises the efficiency findings under the evaluation, with its Table 1 summarising the results by stakeholder category as described below. Efficiency is evaluated by assessing the proportionality of resource input to achieved or expected outcomes, rather than by a cost-benefit ratio analysis. This is due to data limitations and the fact the balance between costs and benefits may evolve in the on-going implementation of the Regulations (see further Annex II, section 3.3).

Manufacturers: Costs & Benefits

Costs - Pre-market clinical/ performance evaluation: Manufacturers reported 196 average costs of approximately €30 000–€250 000 per clinical evaluation, depending on device class and study complexity. The range is substantial, with striking differences between certain risk classes: costs for class Ir 197 devices were around €27 700, while class III devices reached as high as €250 000. Performance evaluations under the IVDR also showed wide variation, for example from about €23 000 for Class B to €70 000 for Class C. No costs could be captured on clinical investigations and performance studies, which tend to exceed costs for clinical evaluations. In the consultation process, industry representatives 198  explicitly identified clinical evidence requirements as one of the main cost drivers under the Regulations. Stakeholders highlighted that SMEs and producers of niche devices are disproportionately affected, often lacking the financial and human resources to absorb such burdens 199 , with some organisations reporting the need to generate new data has already led to product withdrawals. Some stakeholders also argued that re-evaluation under the Regulations for legacy devices with long proven safety records, is redundant 200 and this would imply additional cost. Finally, as seen in section 4.1.1.3, less than half of public consultation respondents were positive on the Regulations contribution to innovation or competitiveness, while many individual comments directly linked negative impacts to the increased costs of clinical investigations and performance studies.

Costs - Conformity assessment: initial certification and maintenance: Certification costs cover both quality management system (QMS) certificates (which demonstrate that the manufacturer is operating under a compliant QMS for device production) and product certificates (which demonstrate that the relevant device meets the requirements of the Regulations). Data is available on different bases: the economic operator survey interpreted as covering the full compliance burden e.g. technical documentation, clinical data, staff resources etc, in addition to fees charged by notified bodies (reported below as ‘costs’); and the interpretation of the notified body survey limited to fees charged (reported below as ‘fees’). Data on costs is reported across the first (i.e. newly issued) and last (i.e. most recent version) certificates issued to manufacturers to provide an indication of cost evolution overtime. Maintenance costs, which include regular surveillance and re-certification activities, involving assessment of relevant updates to the device(s) covered by the certificate as well as the quality management system, are also reported.

For the MDR, for one type of QMS certificate 201 , reported average issuance costs were 641 878 EUR (25 respondents) for first and 882 988 EUR (56 respondents) and last certificates obtained, a 38% increase, with yearly maintenance costs averaging 73 244 EUR (51 respondents). When considering only the fees charged, costs reached 43 417 EUR for first and 48 968 EUR for last certificates obtained, a 13% increase, with yearly maintenance costs averaging 23 469 EUR. Costs varied by firm size in both sources: large manufacturers paying 165% more than SMEs for the last certificate obtained, which were also higher for large firms in terms of fees. However, data collected did not allow for a comparable analysis of cost proportion between large manufacturers and SMEs, and whether this was explained by device risk or company size.  

For another type of QMS certificate 202 , reported average issuance costs reached 100 000 EUR (1 respondent) for first and 188 524 EUR (7 respondents) for last certificates obtained, with yearly maintenance costs averaging 64 914 EUR (7 respondents). When considering only the fees charged, reported costs were 38 877 EUR for first and 32 954 EUR for last certificates, with yearly maintenance costs averaging 11 674 EUR.

For certain types of product certificates 203 , issuance costs were of 616 981 EUR (14 respondents) for first certificates and 385 617 EUR (33 respondents) for last certificates, with yearly maintenance costs averaging 48 503 EUR (31 respondents). When considering only the fees charged, reported costs were 75 532 EUR for first and 68 309 EUR for last certificates, with yearly maintenance costs averaging 16 571 EUR. Evidence indicated higher first-certificate costs for high-risk devices (94 109 EUR) than for medium-risk devices (59 262 EUR), while for last certificates medium-risk devices were costlier (77 032 EUR) than high-risk (63 463 EUR).

For another type of product certificates 204 , overall issuance costs were not available, while fees charged in only two cases suggested issuance costs of 36 657 EUR (first) and 37 932 EUR (last), with zero reported yearly maintenance costs (2 respondents). Similarly, for Annex XI (Part B) only data on fees charged was available (two cases), indicating 7 530 EUR for the last certificate.

For the IVDR, average issuance costs for QMS Annex IX (I+III) certificates were reported at 1 205 458 EUR for first (5 respondents) and 388 918 EUR for last certificates (18 respondents), with yearly maintenance costs averaging 121 250 EUR (12 respondents). When excluding one outlier (a 5.5 million EUR multi-device certificate), the average issuance cost would be 131 823 EUR. For product certificates under Annex IX (II), the average issuance costs were 89 750 EUR for first (8 respondents) and 109 700 EUR for last certificates (10 respondents), with change-management costs averaging 13 563 EUR (8 respondents). Only a small number of manufacturers had completed IVDR recertification by late 2024, providing limited data on actual costs (7 respondents). These ranged between 54 000 EUR and 88 000 EUR but are not representative. A larger group of respondents to the economic operator survey provided estimated figures, suggesting total recertification costs of around 143 000 EUR for QMS and 164 000 EUR for product certificates. Taken together, these figures provide complementary perspectives on the cost impacts of certification under the Regulations.

Hassle costs - Waiting times: as seen in section 4.1.1.2, notified body capacity shortages were a frequently reported problem across stakeholders in the first years of implementing the Regulations. This shortage created delays in certification processes and bottlenecks in market access which was further compounded by lags in the notified body designation process (hence the need for extended transition provisions - see section 3.2). 112 out of 275 contributions to the Call for evidence (40.7%) explicitly highlighted notified body capacity limits and long delays as main obstacles under the Regulations, and variability in notified body practices and costs as a concern 205 . These inconsistencies contribute to unpredictability and longer waiting times for manufacturers. In addition, large manufacturers indicated changing notified body impacted waiting times and resource use, especially those with global market portfolios.

Hassle costs - Administrative burden: Stakeholders consistently flag EUDAMED-related tasks as an administrative burden in qualitative inputs 206 , showing widespread concern about future transparency- and registration-related obligations once all modules are mandatory to use. No consolidated monetary figure can be reported from these sources in spite of all the consultation efforts. In the call for evidence, several contributions reported significant administrative work for UDI/EUDAMED registration, including IT adaptation, translation of data, and staff time. Smaller operators highlighted the disproportionate burden of setting up data flows for EUDAMED relative to their size and portfolio. However, a large majority of contributions recognised significant advantages once EUDAMED is fully operational. Given EUDAMED is not yet fully deployed or mandatory, some manufacturers must also register in national databases, which is perceived as duplication 207 particularly affecting SMEs. Whilst no harmonised cost figures exist, consultation findings 208  suggest the administrative time for this equals several FTE days annually. Another source of administrative burden lies in the many and sometimes overlapping reporting obligations 209  (see also section 4.1.1.5.).

Benefits: Several benefits for manufacturers can be identified based on qualitative evidence. Stakeholders recognise that, in the longer term, the Regulations are designed to provide greater predictability and legal certainty by replacing fragmented national systems with a single harmonised EU framework 210 . Opinions are however mixed: while 446 out of 575 respondents mentioned persistent ambiguity and inconsistent application, a minority of respondents noted that the Regulations have the potential to reduce legal uncertainty once implementation stabilises. In particular, some industry associations underline that harmonised guidance and common EU procedures (such as the Helsinki procedure) could over time improve consistency and predictability 211 . Manufacturers also benefit indirectly from stronger requirements for clinical evidence, post-market surveillance, and vigilance which aim to improve product and therefore patient safety. Although often described as costly, stakeholders 212  acknowledged that these measures improve the credibility of CE-marked devices and reduce reputational and liability risks. Higher safety assurance under the Regulations is also recognised 213 as enhancing international trust in EU-manufactured devices. Several contributors pointed out that international reliance mechanisms and recognition of CE marking—where applied—can facilitate market access and reduce duplicative assessments, meaning that stronger EU oversight can indirectly improve the global competitiveness of compliant manufacturers.

Importers/distributors: Costs

Despite consultation efforts, only limited data is available on costs for importers and distributors 214 , and none was available on benefits. Importers reported an average yearly compliance cost of 115 646 EUR with their obligations (Article 13 MDR/IVDR, verification checks of devices compliance with MDR/IVDR). Excluding an outlier of 5m EUR, the average falls to 32 860 EUR, with 12 importers reporting zero additional costs. For distributors, the average yearly cost reported to comply with their obligations (Article 14 MDR/IVDR, verification checks of devices compliance with MDR/IVDR) was 48 615 EUR. Excluding one outlier of 1.5m EUR, the average is 33 496 EUR, with 24 distributors indicating no additional costs.

Notified bodies: Costs & Benefits

Costs - Compliance: Notified bodies have faced significant costs linked to their designation and the joint assessment procedures, which are more resource-intensive than under the Directives. The need for extensive documentation, repeat rounds of questions, and coordination with multiple national designating authorities has required considerable time investment and additional staff resources. Costs are also driven by staff expansion (particularly experts in clinical, performance, and software assessment), training of staff in the new requirements, and the setup of IT systems for EUDAMED reporting. Capacity constraints meant that notified bodies had to scale up quickly, leading to recruitment challenges and higher overheads. In terms of direct costs, from data collected, it was not possible to determine whether fees charged by notified body covered these.

Hassle costs - Waiting times: The designation of notified bodies under the Regulations has been lengthy and resource-intensive, (with median timelines of around 1 000 days for MDR and 1 300 days for IVDR, see Annex VII, Figure 3) with the longest stages occurring between notified bodies and national designating authorities, pointing to national-level rather than EU-level inefficiencies (see section 4.1.1.2 and Annex VII, Figure 5). Stakeholders, including notified bodies themselves, criticise the lack of harmonisation: designating authorities apply different interpretations and requirements, leading to inconsistent designation timelines across Member States. These uneven and protracted procedures create uncertainty and unequal costs for notified bodies. These waiting times delay market capacity, meaning potential lost revenue opportunities for notified bodies from new certificates (when not yet designated under the Regulations), however with income still being generated from their monitoring activities under the Directives and transitional provisions to support administrative and compliance costs.

Benefits: The Regulations have also resulted in increased revenues for notified bodies, as fees charged to manufacturers for certificate issuance and maintenance are reported, based on implementation experience, to have risen significantly compared to the Directives. This benefit is essentially the inverse of the higher costs faced by manufacturers. Several position papers noted that certification under the Regulations has become a core revenue stream for notified bodies, albeit at the cost of higher pressure and scrutiny (see compliance costs of the manufacturers, section 4.1.2.2).

National Competent Authorities: Costs & Benefits

Costs: national competent authorities (NCAs) reported a strong increase in human resource needs to manage new tasks: qualification/classification disputes, more complex clinical investigation/performance study assessments, and reinforced vigilance and market surveillance obligations. The establishment of EUDAMED required parallel investment in IT infrastructure and training. Coordination efforts also rose, as NCAs had to participate more intensively in the MDCG structures, in joint assessments of notified bodies, and in the development of guidance. Smaller NCAs stressed disproportionate strain on their budgets and staff.

The significant additional human resources needed to fulfil their tasks were most visible in: the assessment of clinical investigation (MDR) and performance study (IVDR) applications, with some countries reporting hundreds of applications over 2021–2024, each requiring staff time ranging from 37 to 156 hours per application 215 ; vigilance and market surveillance, including trend analysis, follow-up of incident reports, signal detection, and EU-level reporting obligations. These activities represent a significant proportion of recurring cost and resources, even where incident volumes are moderate. In addition, notified body designation and oversight by national designating authorities; regulatory and policy tasks, including national guidance and policy development, legal issues and qualification/classification disputes required additional resources. On the latter workload varied amongst Member States due to differing number of disputes reported.

Benefits: At the same time, NCAs gained a more central role in harmonised oversight of the market. The framework clarified their responsibilities in vigilance and market surveillance, giving them more legal certainty and a stronger mandate to intervene. The coordinated work in MDCG was also perceived as improving consistency across Member States, though uneven implementation still remains. Overall, NCAs now have stronger tools for market surveillance and can rely on common EU platforms for coordination, device traceability systems for safety monitoring such as UDI and eventually tools, such as EUDAMED once fully deployed and mandatory.

Health Providers: Costs & Benefits

Costs: Health institutions experienced administrative burdens under the Regulations. Those producing in-house devices, reported extensive documentation requirements without proportional perceived benefits in patient safety. Due to the limited response rate however, there is no significant quantitative information available. Laboratories under IVDR highlighted significant compliance costs for validation and performance studies of in-house diagnostics, which diverted resources from research and patient care. Academics, businesses, and health professionals reported delays in access to innovative devices, as shortages and market withdrawals affected treatment options, especially in niche therapeutic areas 216 . From one evidence source, a price increase for some medical devices was also reported by health professionals 217 .

Benefits: Despite the costs, health providers recognised improvements in safety assurance and clinical evidence requirements for devices used in their practice. They also welcomed greater transparency, particularly through EUDAMED (once fully implemented), which is expected to help them verify compliance and device status.

Patients and Users: Costs & Benefits

Costs: For patients, the main costs are indirect: reduced availability of devices due to withdrawals from the Union market and delays in certification of innovative products. Patient organisations also highlighted inequities in device availability for rare diseases, paediatric conditions, and vulnerable groups including withdrawals (see section 4.1.1.3). This was echoed in 14% of position papers, underscoring the tension between maintaining high safety standards and ensuring continued access for vulnerable patient populations. In the Call for Evidence, stakeholders noted that extensive and long-term performance study requirements can be difficult to meet for rare conditions, where patient cohorts are small, Patient representatives and users also reported difficulties in signalling device safety issues. 218

Benefits: Across consultation sources, perceptions of safety outcomes are mixed. Stakeholders generally recognised that the MDR and IVDR have strengthened the regulatory framework by introducing stricter requirements for clinical and performance evidence, reinforcing post-market surveillance, and improving traceability through mechanisms such as the UDI. Patient organisations and consumer groups also welcomed the increased transparency of CE marking, with EUDAMED expected to further enhance public access to safety and performance information.

At the same time, many respondents underlined that these benefits are not yet fully visible in practice, mainly because of the gradual implementation and ongoing transition. In the Call for Evidence, 89 out of 253 respondents reported that the Regulations had not yet improved safety for patients—though this reflects perceived delays rather than a decline in safety. The evaluation also confirms that these strengthened safety provisions correspond closely to the objectives identified in the 2012 Impact Assessment, which anticipated that the new framework would prevent major safety incidents, such as those involving defective implants. Although quantitative estimates of avoided incidents or related costs are unavailable, implementation experience indicates no major crises under the Regulations. The Regulations’ safety requirements intend to reduce the likelihood and consequences of such events through stronger oversight, improved traceability which benefits patients.

In consultations, consumer organisations and public authorities emphasised the value of higher safety standards and the transparency achieved under the new system. Patient organisations also supported robust rules as essential for safety and trust, while calling for proportionate approaches that minimise disruptions to care. In summary, patients benefit from a stronger, more transparent, and more predictable safety system, which over time is expected to improve trust in medical devices and prevent serious incidents. These benefits have not yet fully materialised but represent the long-term public health value of the Regulations as the implementation continues and reaches its full potential.

EU-level Governance: Costs & Benefits

Costs: For the Commission and EU-level governance structures, the Regulations entailed substantial IT development and maintenance costs for EUDAMED, alongside significant staff resources for managing MDCG coordination and regulatory/policy guidance development. For example, EUR 6 000 000 and 4 700 000 was allocated to EUDAMED development under the EU4Halth Work Programmes in 2023 and 2024 respectively. 219  The Commission also incurred costs for running joint assessments of notified bodies, facilitating harmonised implementation, and supporting expert panels which are run by the EMA. However, consultations handled by EMA under the Regulations have faced procedural inefficiencies, including unclear criteria for initiating consultations for certain device categories, variable quality of documentation submitted, and challenges in managing timelines and follow-ups. 220 These activities required sustained budgetary allocations and specialist staffing.

Benefits: At EU level, the reinforced governance system is enhancing harmonisation of how medical devices are regulated in the EU. The EU has maintained its global position in the MedTech sector and with stricter standards set, still influences international markets with continued reliance on the CE mark (see section 4.1.1.3). The increasing harmonisation of market surveillance, vigilance, and scientific support by the expert panels, as well as EUDAMED’s potential once mandatory, contributes to improved oversight of device safety at EU level, which was previously fragmented or duplicated across national frameworks.

4.1.3.Coherence

The coherence of the Regulations was assessed by determining the complementarities or overlaps of provisions within and between the two Regulations (internal coherence) as well as their alignment to other EU legislation, policies and priorities, and international initiatives (external coherence).

To what extent are the various elements of the MDR and IVDR coherent with one another (internal coherence)?

The evaluation of the internal coherence between various elements of the Regulations identified some specific issues and revealed mixed perceptions from stakeholder groups. There was low agreement, ranging from 35% to 44%, regarding the internal coherence within each Regulation and their coherence with one another 221 . Whilst there is little evidence from other consultation activities 222 on major issues or specific examples of incoherent provisions, common recurring inconsistencies mentioned were regarding the use of terminology and contradictory requirements 223 .

On coherence between the Regulations, approximately 80-85% of provisions are the same or similar 224 . Whilst this may suggest a high level of consistency, inconsistencies remain. This is especially where IVDR provisions are too extensively modelled on MDR provisions, meaning IVDs and medical devices with a different nature or risks, are treated similarly. This is seen with the four-tier risk classification in both Regulations (see also Annex VII, Figures 7 and 8), as well as the respective conformity assessment procedures and level of notified body oversight. For example, a sterile class I medical device which may pose an infection risk due to direct patient contact, is treated in the same way as a sterile class A IVD, where the sterility ensures reagent stability and assay function and there is no patient contact. Additional examples of inconsistencies include 225 :

·The provision of electronic instructions for use (eIFU) by manufacturers to professional users is permitted for all devices for professional use under the MDR, whilst the IVDR excludes devices for near-patient testing from this possibility.

·Despite similar ‘medium’ risk levels, Class IIa medical devices can follow a simpler EU quality assurance certification, whilst this option is not available to Class B IVDs facing stricter certification requirements (under Annex IX IVDR). This discrepancy creates challenges, especially for SMEs.

·The MDR recognizes the concept of ‘well-established technologies’ and applies lighter requirements to them, but the IVDR lacks this concept, even though under the IVDR there are also many legacy products with a proven history of safe use.

·The cross-application of the 'surgically invasive' concept from the MDR to the IVDR doesn’t adequately account for the specific nature of IVDs, leading to excessive scrutiny for low-risk IVD performance studies, like routine blood draws. Consequently, these studies face stringent requirements akin to high-risk medical device procedures, creating unnecessary burdens without added value for patients.

As for coherence within the Regulations, the use of terms and definitions also show inconsistencies. Whilst some terms are defined, both Regulations also rely on key concepts which appear, but are not defined in the text, creating uncertainty for stakeholders. "Intended purpose" is defined in Article 2(12) (a key term for manufacturers when qualifying their product as a medical device) but is not distinguished from the related but undefined term "intended use". In addition, the terms "significant change" and "substantial change" in the Regulations are undefined and often confounded 226 . Though similar, they serve distinct functions under the MDR and are not interchangeable.

In addition, implementation experience has shown inconsistencies between the MDR/IVDR requirements and their accompanying Annexes. For example, the MDR clinical evaluation (Article 61(1)) suggests that confirmation of conformity with all relevant general safety and performance requirements (GSPRs) would need to be based on clinical data, whilst the corresponding Annex (Annex XIV) specifies that manufacturers need to identify the GSPRs that actually require support from clinical data in their clinical evaluation plan. Moreover, the MDR seems to mandate manufacturers to conduct clinical evaluations, including a Post-Market Clinical Follow-up (PMCF) in all cases in Articles 10(3) and 61(11) and Annex XIV, Part B, whilst the Annexes II and II on post-market surveillance technical documentation allow manufacturers to justify why PMCF is not applicable. Finally, various manufacturer obligations are outlined in Article 10 of the Regulations by cross-referencing more detailed provisions. Aside from duplicating information, not all manufacturer’s obligations are comprehensively listed.

To what extent are the MDR and IVDR coherent with other EU (and, if applicable, national) interventions that have similar objectives (external coherence)?

Consulted stakeholders showed a low level of agreement ranging from 4% to 34% on the alignment of the Regulations with other EU legislation, depending on the initiatives being compared 227 (see detailed views in Annex V, section 3.5). However, it’s important to also consider some frameworks consulted on were adopted after the Regulations, and this along with other external factors can impact coherence levels. 

This perceived low alignment also relates to the complexity between MDR/IVDR and other EU Regulations, and the need to avoid contradictory requirements or overlaps with horizontal frameworks 228 (see Annex V). Various EU regulations may apply to the market placement of medical devices or IVDs, affecting coherence. Whilst the MDR/IVDR in Article 1 establishes a hierarchy for some overlapping requirements (e.g. Medicinal Products Directive 229 ) or applicability of complimentary regulations (e.g. the Machinery Regulation 230 ), this is not true in all cases. Examples for improved alignment commonly called for across stakeholder groups were to the Artificial Intelligence Act 231  (AI Act), the Clinical Trials Regulation 232 (CTR) and environmental legislation, to reduce inefficiencies, administrative burdens and improve regulatory certainty. Reflections of MDR/IVDR coherence to a number of other EU frameworks are detailed below 233 :

·The CTR has coordinated processes, however no EU procedure for combined studies (involving both medical devices or IVDs and medicines) exists, requiring sponsors to submit separate applications under multiple frameworks. Greater alignment is needed to ensure innovative therapies can be developed safely and efficiently. 

·Under the AI Act, medical devices can be classified as high-risk AI systems (Article 6(1) AI Act) leading to closer interactions with the MDR/IVDR. There is lack of clarity for manufacturers regarding conformity assessment and certificate timelines due to challenges related notified body designation for the purpose of single conformity assessment of MDAI (medical device with artificial intelligence). 

·The Network and Information Systems II Directive 234 (NIS2) establishes a cybersecurity framework for critical sectors in the EU. Some medical devices or IVDs will fall in scope if deemed ‘critical during public health emergencies’ 235 , which may lead to dual reporting for certain manufacturers due to differing focuses of MDR/IVDR on device safety and NIS II on cybersecurity.

·The European Health Data Space (EHDS) Regulation 236  creates requirements for the interoperability of electronic health records systems that also medical devices which claim interoperability with such systems need to comply with. These requirements affect also manufacturers of such devices.

·The Health Technology Assessment Regulation (HTAR) 237  establishes a legal framework for the joint clinical assessment (JCA) and joint scientific consultations (JSC) of health technologies, including select medical devices and IVDs 238 . JCA reports analyse the relative effectiveness and safety of a health technology compared to existing ones and JCA procedural rules govern interactions with developers and notified bodies. Further alignment may be needed to simplify procedures and reduce duplications related to document submissions, in particular, via the use of EUDAMED.

·The Batteries Regulation 239  applies to medical devices and IVDs, requiring compliance with both frameworks. It mandates sustainability, battery-specific design, and environmental measures, while the MDR/IVDR focuses device-specific safety and performance requirements. Overlapping obligations can arise, such as the Batteries Regulation's requirement for user-removable and replaceable batteries versus the MDR/IVDR's need for sealed compartments in devices for safety, sterility, and performance. Whilst partial exemptions exist for certain devices, other manufacturers have to balance arguably contradictory requirements.

·The Packing & Waste Regulation (PWR) 240  and the MDR/IVDR have differing objectives creating challenges for the implementation of certain environmental requirements of the PWR. While MDR/IVDR focus on risk/benefit assessment, performance and safety, the PWR focuses on packaging recycling and minimisation. Exemptions exist for contact-sensitive packaging, but manufacturers may still face challenges in finding suitable non-recycled materials and suitable packaging design to ensure sterility is maintained

To what extent are the MDR and IVDR coherent with (current) wider EU policies and priorities (external coherence)?

By supporting the safety and performance of medical technologies, the Regulations align to the EU’s wider health policy objectives of strengthening health systems and improving citizens’ well-being under the One Health approach 241 . In addition, the Regulations are included in and align with the European Health Union Strategy 242 , which seeks to strengthen crisis preparedness, including via medical supplies availability. For example, the Regulations include emergency derogations for the availability of medical devices and IVDs based on patient or public health needs (Articles 59 MDR/54 IVDR) and provisions for non-emergency related reporting on supply interruptions and discontinuations (Article 10a MDR/IVDR, see also section 4.1.1.3). The latter is however not directly linked to management of public health crisis supplies by the EMA 243 .

Based on the findings in sections 4.1.1 (Effectiveness) and 4.1.2 (Efficiency), the Regulations do not seem to adequately align to the EU’s current competitiveness agenda. To enhance competitiveness and sectoral resilience as outlined in the EU Life Sciences Strategy 244 , the Commission announced in August 2025, a simplification revision of the MDR and IVDR 245 . This should improve the coherence of the Regulations to wider policy priorities of the Draghi report on EU competitiveness 246 , the “Competitiveness Compass” 247 and the Simpler and faster EU communication Simplification and Implementation 248 , which under the current framework is not being achieved. Finally, in terms of the EU’s priority to close the innovation gap in its Competitiveness Compass and support SMEs (e.g. the EU start-up and scale-up strategy 249 ) the current Regulations do not make special considerations for SMEs, who are mostly subject to the same rules and similar related costs/administrative burdens as large undertakings (see section 4.1.2). 

To what extent are the MDR and IVDR coherent with international obligations and policies (external coherence)?

Whilst not holding obligations under international treaties in the medical devices field, the EU upholds its obligations under bilateral trade agreements and commitments to multilateral cooperation, notably in the IMDRF (see section 4.1.1.3). As an IMDRF Management Committee member, the EU actively participates in the development of globally harmonised principles and guidance and many IMDRF foundational concepts are reflected in the Regulations. Although the Regulations align with IMDRF objectives, they lack direct links to IMDRF and other internationally recognised guidance documents. Whilst the Regulations embody the EU’s commitment to international cooperation and regulatory convergence, further aligning EU regulatory implementation with IMDRF principles would strengthen global coherence and reduce unnecessary regulatory burden for innovators and manufacturers, while maintaining robust oversight and patient safety. 

4.2.How did the EU intervention make a difference and to whom?

The Regulations have introduced a more robust legal framework for safety and clinical requirements for medical devices and IVDs, whilst establishing appropriate surveillance and vigilance mechanisms. Without reinforced EU intervention, diverging interpretation, transposition and enforcement of Directives and national laws would have persisted, hindering manufacturers' access to the EU single market and resulting in continued uneven health safety and protection levels for patients and users across the EU. The Regulations are in the process of positively impacting stakeholders, including industry and patients, who prefer one EU regulation over individual national legislations governing medical devices and IVDs 250 . Stakeholders also recognise the cost benefits in complying with one EU Regulation over different rules at the national level 251 , however continued divergences in the interpretation and implementation of the Regulations mean the intended benefits are not yet realised.

While new requirements often come at increased cost, the Regulations offer strengthened requirements and, in some areas, greater predictability and legal certainty for manufacturers compared to the Directives, or to what could have been expected if Member Stated acted alone. A unified and strengthened framework, including centralised implementing tools (like the EUDAMED database) improves trust in the CE mark (both in Europe and globally) and credibility in the regulatory system, benefitting manufacturers selling CE marked devices and patients. Additionally, harmonised guidance and common EU procedures can improve consistency and level the playing field for manufacturers. As for competitiveness and innovation, a harmonised framework under the Regulations should have created a more even playing field internally (boosting competitiveness among EU players) and encouraged reliance from international partners (boosting global competitiveness of CE marked devices). Despite on-going EU activities to improve the situation (see section 4.1.1.3), this potential is yet to be realised as the Regulations are still being implemented.

The Regulations also introduced infrastructure to increase the harmonisation of notified body designation and oversight. Whilst not proving fully effective (see section 4.1.1.2), including in terms of resources allocated at national and EU levels, this contributes to setting a more even playing field for both notified bodies and manufacturers. In addition, albeit operational uncertainty in their implementation is still lacking (see section 4.1.1.1), extensive Regulation requirements for notified body designation and conformity assessment activities have the benefit of setting common requirements across the EU, increasing trust and credibility in notified body issued certificates.

Significant EU added value comes from more centralised governance and coordination mechanisms for Member States and the EU institutions, under the Regulations. First, though not always seen as enhancing operational legal certainty (see section 4.1.1.1), MDCG discussions and guidance documents aid in implementing and enforcing the Regulations and tackling emerging challenges, such as on qualification and classification or new technologies. Second, strengthened provisions on market surveillance and reporting for national competent authorities, enhances information sharing among on devices and contributes to patient and user safety (see section 4.1.1.4). This coordination brings particular value when taking enforcement measures or related decisions against operators, which can be based on more comprehensive and less divergent information, thereby improving efficiency. By increasing vigilance and market surveillance collaboration and coordination, the Regulations ensure a more uniform approach to addressing patient and user safety risks across the EU, preventing divergence and inconsistent health protection levels among Member States (see section 4.1.1.3).

The Regulations have put in place a positive regulatory framework to ensure improved levels of safety and performance of devices for patients and users, regardless of the EU Member State in which they seek healthcare. Harmonised rules are recognised as improving patient safety 252  due to stricter requirements for clinical evidence (see section 4.1.1.2), reduced divergences in safety standards, improved coordination by competent authorities, and increased capacity for early risk detection. The Regulations are also increasing information on devices, via transparency and traceability mechanisms using EUDAMED, UDI and public reports, enabling patients and users across the EU to make more informed health decisions. However, the full potential for increased transparency, and therefore trust in the system remains unrealised due to delays in the necessary implementation tools (see section 4.1.1.1).

Finally, from an EU added value perspective, the proportionality of the Regulations lies in the fact that a single, harmonised EU framework can achieve a higher and more consistent level of safety and market oversight than fragmented national systems, even if this comes at (temporarily) high compliance costs. Around half of the stakeholders consulted believed that it was feasible to maintain adequately safe devices while reducing costs 253 . However, as shown in section 4.1.2, these costs are not always proportionate across actors, indicating that the efficiency of the EU-level intervention could be further optimised.

4.3.Is the intervention still relevant?

The key objectives of the Regulations - to ensure high heath levels for patients and users, facilitate a smooth functioning internal market, support competitiveness and innovation, and achieving robust transparency for medical devices - remain important today.

Despite implementation challenges (see section 4.1), the Regulations are still relevant in ensuring that users and patients benefit from safe and performant medical devices. This is recognised by EU level healthcare and patient associations who state ‘the objectives of the Regulations remain valid and that any new measures must be guided by the interests of patients and the public health’ 254 . Stakeholders also suggest that the Regulations’ stringent requirements, especially regarding clinical evidence, reporting and coordination of serious incidents, and the involvement of external expertise, have improved the regulatory framework 255 . Some stakeholders however question the Regulations’ long-term efficacy in achieving safety objectives. Less than half of respondent to the study on governance believed the Regulations will ensure safe and performant devices in the next 5-10 years 256 . However, this could also be linked to effectiveness and efficiency in the implementation of the Regulations.

The Regulations seek to ensure that patients, users, and all key players have access to transparent information on the devices, such as on their intended purpose, how to use them and the associated risks. A majority of consulted citizens agreed they have access to information on the device’s use and associated risks. 257  Nevertheless, representatives of healthcare professionals noted that whilst EUDAMED will provide more information on devices, it will still not contain data needed to make informed clinical decisions (e.g. clinical evidence on high-risk devices, safety reporting outcomes) 258 – a perspective echoed in the Call for Evidence feedback 259 . Stakeholders overall supported greater transparency through EUDAMED, UDI, and public access to clinical data 260 . This shows that the objective of transparency of the Regulations remains a priority across stakeholder groups.

The objectives of the Regulations related to the smooth functioning of the internal market and the support to competitiveness and innovation in the sector remain relevant. As the second largest market globally, the European medical technology sector plays a key role in strengthening the EU’s strategic autonomy and global positioning. However, stakeholders do not consider the Regulations effective in stimulating innovation, viewing the current framework as disproportionate in some areas, particularly disadvantaging SMEs and start-ups, 261  and lacking centralised, harmonised regulatory and scientific early guidance to manufacturers 262 . 

In terms of meeting the evolving needs of patients in the EU, the Regulations are not seen as meeting their full potential. In particular, for niche and orphan devices for small populations with low-demand, stakeholders question whether the regulatory framework sufficiently supports current needs and technological developments. Applying the same regulatory requirements as for other devices (with higher demand) is seen as disproportionate and misaligned with the policy of ensuring access to critical devices. Stakeholders therefore advocate for dedicated regulatory pathways to better align with the evolving patient needs in the EU. 263  In terms of addressing patient needs with emerging health challenges, stakeholders indicate limited relevance of the Regulations. Nearly 56% of public consultation respondents for medical devices and 60% for IVDs believe the current framework falls short, 264 echoed also in the Call for Evidence 265 . 

Considerable scientific and technological developments (e.g. digitalisation, artificial intelligence, medical device software, wearables and robotic surgery) are transforming the medical devices sector. Since the adoption of the Regulations, many of these advancements have progressed, yet the Regulations are not perceived as sufficiently supporting innovation 266 , which may hamper innovative devices reaching the EU market 267 , 268 . Overall, stakeholders agree that the complexity of the Regulations hinders innovation, making the EU less attractive for clinical research and product launches, and therefore lack relevance to today’s needs. They call for a more balanced and harmonised approach, with regulatory simplifications to foster innovation and ensure timely access to new technologies 269 .

To what extent are the processes and mechanisms of the MDR and IVDR still relevant in view of the objectives?

The Regulations formalised and expanded several processes and mechanisms from the Directives and introduced new ones, including a stricter joint assessment process for notified body designation, robust post-market oversight mechanisms (e.g. coordinated safety assessments) and pre-market review mechanisms (e.g. coordinated assessments of clinical investigations). Whilst not always fully effective or efficient, (see sections 4.1.1.2, 4.1.1.4 and 4.1.2), these processes remain relevant to achieve the Regulation’s patient safety and health protection objectives. The Regulation’s transparency and traceability tools, such as UDI and EUDAMED, further support informed healthcare decisions, for users and patients, remaining essential to achieve the Regulation’s transparency objectives. However, certain processes and mechanisms have resulted in unintended consequences that hamper the goals of a smooth functioning internal market, supporting competitiveness and innovation and reducing efficiencies whilst enduring device availability (see section 4.1.1.5).

5.1.Conclusions

The performance of the Regulations to date must be viewed in the wider context of its on-going implementation and the extended transitional periods. The evaluation builds on a range of evidence sources. Limitations, including on data availability and cost quantification, are identified in the methodology. In this context, the evaluation draws conclusions regarding the Regulation’s effectiveness, efficiency, coherence, relevance and added value which offer lessons for future improvements. Overall, the benefits of the Regulations for patients and healthcare systems are materialising by strengthening device safety and performance and increasing transparency. However, this comes at a high and often disproportionate cost vis-à-vis compliance requirements, with administrative complexity and uneven progress across objectives and actors.

Effectiveness

The Regulations have introduced stricter requirements for the designation and oversight of notified bodies, the conduct of conformity assessment activities, the generation of clinical evidence supporting the safety and performance of devices, the post-market oversight of devices, and increased transparency requirements. They have also strengthened harmonisation and coordination mechanisms across all governance levels. As a result, whilst not always effective in achieving its objectives to date, the EU regulatory framework for medical devices benefits from a more robust infrastructure for safe and performant medical devices, with enhanced safeguards to respond more effectively to potential safety risks and increased access to information. Several unintended consequences have also been identified, namely; implementation delays, an increased administrative burden, longer timelines and increased costs to achieve market access, inconsistent application of regulatory requirements, and a complex regulatory governance structure. These are partially due to external factors, such as the COVID-19 pandemic, but also to due structural drivers, such as overlapping requirements, slow guidance development and limited notified body capacity. Together, these contribute to a perceived unpredictability and disproportionality of the system, undermining trust, including of healthcare professionals, patients and users. Ultimately, this results in a decrease in the availability of certain devices, particularly innovative and niche devices, thus having a negative impact on both competitiveness – including at global level - and the protection of health for patients.

Progress towards the objectives of the Regulations remains uneven across key areas. Legal certainty, transparency for all actors and citizens, and trust are advancing to different levels, but remain unfulfilled. The complexity of the frameworks and the need for further clarification of legal provisions continue to create operational uncertainty among stakeholders. Transparency and trust in the regulatory system are not yet achieved but are expected to improve once remaining infrastructure and tools are fully functional, with a positive perspective to reach the objectives by the end of the transition period. Objectives related high health protection via post-market surveillance, vigilance, and market surveillance show better progress. Evidence shows improved traceability, oversight, and patient safety, and these objectives are expected to be largely achieved by the end of the transition periods. Concerning notified bodies, conformity assessment, and clinical evidence, notified body capacity under the MDR has largely stabilised, but remains to be determined under the IVDR. Harmonisation of conformity assessment practices across notified bodies and Member States is still limited, thus making it uncertain whether full alignment can be achieved by the end of the transition periods. Clinical evidence is increasing however, the intended robustness and availability of clinical evidence and data under the Regulations is not yet achieved.

The objectives of ensuring a smooth market functioning and level playing field and supporting competitiveness and innovation (taking into account the specificities of SMEs), have not yet been met. Regulatory complexity and uneven application across Member States have constrained the ability of manufacturers – particularly SMEs – to innovate and compete on equal terms. This has also impacted device availability, and the ability to cater for specific patient needs. Although the EU market remains the second largest globally and a leading originator of patents, the pace of innovation appears slower than in more agile markets, such as the US, suggesting a gradual loss of competitiveness. While the framework has the potential to enhance the EU’s competitiveness on the global stage, this will require greater predictability, international alignment, and support for smaller actors to sustain innovation and market participation. Regarding simplification and streamlined procedures, the existing structure of governance have facilitated collaboration, but remain resource-intensive and slow to deliver outputs. Without further structural adjustments, this is unlikely to improve.

Finally, the extensions of the transition periods alleviated the immediate risks of device shortages and capacity pressures on notified bodies, particularly under the MDR, though projecting the longer-term effects remains difficult. They also provided manufacturers additional time to adapt and ensure continued availability of critical devices. However, while the extensions offered the necessary temporary relief, they have had limited effects on resolving the underlying hurdles presented by the Regulations and device availability issues remain. If left unresolved, this could have more serious consequences for patient care and particularly for vulnerable patient groups.

Efficiency

The Regulations have brought benefits for patients when it comes to introducing stronger safety requirements, better evidence standards and transparency, with potential to increase system trust overtime. Nevertheless, when analysing whether compliance costs increased compared to the Directives – which was an expected outcome taking into account the higher ambition of the new framework – evidence shows that the gains are uneven, especially for manufacturers. The distribution of costs is uneven, with SMEs and manufacturers of niche devices bearing a disproportionate share, while larger operators are better able to absorb the compliance effort. This has contributed to a reduced availability of devices, particularly for rare diseases and niche products, with some manufacturers withdrawing from the market due to high compliance costs and limited notified body capacity. These effects risk offsetting some of the intended benefits such as a high level of patient protection. While the Regulations are expected to deliver benefits that ultimately outweigh their costs, the balance between regulatory burden and public health gains could be further improved. Streamlining procedures, enhancing coordination, and reducing unnecessary administrative complexity would help ensure that efficiency gains accompany the strengthened safety achieved under the new framework.

Coherence 

Overall, provisions between the Regulations (MDR and IVDR) and within the Regulations are coherent (internal coherence), however inconsistencies remain in terminology and requirements. Between the Regulations, a large majority of provisions are similar; however, discrepancies exist, especially where requirements or concepts are cross-applied from the MDR to the IVDR (despite differing product risks and nature), or allowances are made in the MDR (for electronic IFUs or ‘well-established technologies’) but not in the IVDR, creating implementation challenges. Additionally, within the Regulations, undefined terms and inconsistencies between the Regulations' requirements and Annexes further complicate implementation. In terms of external coherence, while no major incoherences were identified between the Regulations and other EU frameworks, stakeholder perception of alignment was low, and highlighted the need to avoid contradictory requirements or overlaps especially with digital, environmental and other health legislations. While the Regulations align with EU’s health policy objectives by supporting medical technology safety and performance, they fall short on the EU's competitiveness agenda. Finally, the Regulations reflect the EU’s commitment to internation cooperation, especially through participation in the IMDRF, yet strengthening alignment with international principles could reduce regulatory burdens and enhance global coherence.

EU Added value

Stakeholders prefer a unified EU Regulation over individual national laws for improved consistency and potential for cost efficiency. While the Regulations have streamlined requirements, national implementation practices still vary. Despite increased costs for manufacturers, the Regulations provide the infrastructure and potential for greater predictability, legal certainty, and enhanced patient safety through detailed safety requirements and harmonised procedures. Strengthened safety requirements and transparency tools, including UDI and the EUDAMED database contribute to enhancing credibility, trust, and international competitiveness of CE-marked devices. Although not fully achieved, harmonisation of notified body designation and oversight improves consistency in applying requirements, strengthening certificate credibility and showing EU added value of the Regulations. Finally, enhanced coordination among national authorities boosts device safety monitoring, ensuring uniform patient protection across Europe.

Relevance

The Regulations remain relevant to their core objectives of ensuring patient safety, public health protection, transparency, and the smooth functioning of the internal market. These goals continue to address fundamental societal needs, particularly through strengthened evidence requirements, oversight mechanisms, and traceability measures. However, the evaluation shows that objectives linked to innovation, technological development, and competitiveness – especially for SMEs – face increasing challenges, as certain regulatory requirements are not yet fully adapted to the evolving technological and market realities. Stakeholders widely agree that while the main objectives remain valid, implementation can limit innovation, development of niche devices, and the uptake of emerging technologies. Uneven impacts across economic operators also point to the need for greater proportionality and flexibility. Overall, the Regulations provide a relevant framework for ensuring the safety and performance of medical devices, but targeted adjustments are needed to ensure that they remain fit for purpose in a rapidly changing technological and healthcare environment. Finally, while the Regulations’ processes and mechanisms remain relevant in view of the objectives, certain provisions have led to unintended consequences that limit their full potential.

5.2.Lessons learned

Stakeholders have consistently emphasised the need to streamline and simplify the regulatory governance framework for medical devices and IVDs. Harmonised notified body designation and oversight, centralisation and strengthening of regulatory governance structures, and improved coordination amongst authorities and notified bodies are seen as key to reduce fragmentation and ensure a more cohesive regulatory framework. In addition, streamlining the work of the MDCG and its technical sub-groups, and moving from consensus to more effective decision-making mechanisms would result in a more efficient and responsive system, capable of delivering outcomes in a timely manner.

Moreover, the increased administrative burden resulting from the Regulations could be addressed by streamlining reporting obligations as well as avoiding duplication and overlapping of reports and their assessment. The predictability of the system could be enhanced by allowing early dialogue with notified bodies, ensuring clear certification timelines, and addressing resource-intensive and lengthy consultation procedures. In addition, addressing the perceived disproportionality in the system, particularly with low and medium risk devices, and developing flexible regulatory pathways for innovative and niche devices, could improve the competitiveness of the Union market, while ensuring the continued availability of devices for diverse patient populations and emerging healthcare needs. Finally, by further advancing digitalisation initiatives, such as electronic instructions for use (e-IFUs), electronic labelling, and the development of electronic submission systems, the regulatory framework could become more accessible, efficient, and aligned to evolving sectoral needs.

Overall, lessons learned from the evaluation will provide context to the Commission’s on-going simplification of the Regulations, planned for adoption in December 2025, which aims to enhance competitiveness of the sector, and support innovation whilst making safety requirements more cost-efficient, predictable and proportionate.

Lead DG

The European Commission’s Directorate-General (DG) for Health and Food Safety is the lead DG for this targeted evaluation (PLAN/2024/451). The targeted evaluation was included in the Commission Work Programme 2025 (COM (2025) 45 final).

Derogations and justification

No derogation was requested.

Organisation and timing

Work on the targeted evaluation started in 2024. The Call for Evidence document and the Public Consultation were open for contributions from 12 December 2024 to 21 March 2025.

An interservice coordination group (ISCG) involved representatives from DG BUDG, DG COMP, DG CNECT, DG ENER, DG ENV, DG GROW, DG HERA, DG RTD, DG SANTE, DG SG, DG TRADE, SJ (Legal Service) and the JRC, and held 8 meetings between July 2024 and November 2025. The ISCG contributed to the targeted evaluation by ensuring its scope is comprehensive and its approach sound and robust.

Consultation of the Regulatory Scrutiny Board

The targeted evaluation was not selected for scrutiny by the Regulatory Scrutiny Board.

Evidence, sources and use of expertise

Members of the Medical Device Coordination Group (MDCG) were regularly consulted on the targeted evaluation. The Commission informed the members of the planning of the targeted evaluation in its May 2024 MDCG meeting. The targeted evaluation has been discussed in every MDCG meeting since then (6 MDCG meetings), with a dedicated workshop during the meeting of the MDCG in February 2025.

In addition to the contributions to the Call for Evidence and the Public Consultation, the Commission organised targeted consultation activities informing the targeted evaluation. These include a series of targeted surveys tailored to specific stakeholder groups (Economic Operators, Notified Bodies and National Competent Authorities, EMA), two reality checks workshops (one workshop with manufacturers, one workshop with healthcare professionals, patients and users) as well as the organisation and participation to events/conferences, such as the information session on the evaluation for regulators from non-EU countries. The targeted evaluation was also based on the analysis of position papers and written submissions from stakeholders as well as desk research and documentary analysis, drawing on official reports, MDCG guidance and previous evaluations. For more details, see Annex V – Synopsis Report.

Furthermore, the Commission launched external studies and benefited from insights from external experts:

·One study (Ernst and Young, Study on Regulatory Governance and Innovation in the field of Medical Devices - Final report, Publications Office of the European Union, 2025, DOI:10.2875/8995410) analysed the regulatory governance and innovation in the field of medical devices. Several consultation activities took place in the context of this study, including one workshop dedicated to SMEs.

·Another study (Technopolis, Study supporting the targeted evaluation of the MDR and IVDR - Final report, December 2025, under preparation) analysed some of the evidence collected in the context of the consultation activities and performed case studies.

·One external expert supported the evaluation by providing overall methodological support.

·Another external expert provided input to an analysis of the coherence of the Regulations.

Each source contributed distinct strengths: targeted surveys yielded structured numerical data; open consultations captured perceptual and contextual insights; and desk research provided factual and institutional background.

All methodological details on the preparation, sampling and data processing of these sources are presented in Annex V (Methodological section of the Stakeholder Consultation), in line with Tool #54 of the Better Regulation Toolbox (“Analysing data and informing policymaking”).

1. Introduction

This methodological annex provides a transparent and detailed description of how the targeted evaluation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) was designed and conducted. It complements the analytical findings presented in the main Staff Working Document (SWD) or the ‘Evaluation Report’ and follows the methodological standards set out in the Better Regulation Guidelines and Better Regulation Toolbox (2023 edition).

The annex explains how evidence was structured and synthesised across the five evaluation criteria of effectiveness, efficiency, coherence, relevance, and EU added value. It describes how the analytical work was anchored in a formal evaluation matrix, how mixed sources of evidence were integrated through triangulation, and how the results were assessed using a transparent scoring system. It also sets out the limitations of the available data, the measures taken to mitigate these, and the approach used to manage uncertainty and ensure the robustness of results. It also explains the specific analytical framework used to assess efficiency and the relationship between costs and benefits, consistent with the Better Regulation Toolbox (Tools #57–#61).

The annex does not describe the data-collection process itself. Details on the preparation, dissemination and processing of the consultation activities - including the Call for Evidence, Public Consultation, and the targeted surveys are presented separately in Annex V (Methodological section of the Synopsis Report).

Overall, this annex demonstrates that the evaluation has been implemented in full coherence with the Commission’s Better Regulation principles of transparency, proportionality, and evidence-based policymaking (Tool #4).

2. Evaluation design

2.1. Conceptual basis

In accordance with Tool #45 (“What is an evaluation and when it is required”) and Tool #46 (“Designing the evaluation”), the analytical design follows a structured sequence linking the intervention logic, evaluation questions, judgement criteria and indicators.

The revised intervention logic for the MDR and IVDR provides the backbone for the evaluation. It maps how the Regulations’ inputs (legislative provisions, governance structures and resources) are intended to produce outputs (reinforced certification procedures, clinical investigation/performance studies and post-market surveillance), leading to results (harmonised oversight, improved transparency, strengthened safety) and ultimately to long-term impacts (patient protection, public trust, competitiveness and innovation) (see Figure 2 in the Evaluation Report).

From this logic, an evaluation matrix was developed in line with Tool #46 and Tool #47 (“Evaluation criteria and questions”). The matrix ensures that each of the five evaluation criteria is operationalised through clear, non-overlapping questions and that each question is supported by explicit judgement criteria, measurable indicators and identified sources of evidence.

·Judgement criteria define the qualitative or quantitative standards against which progress is assessed.

·Indicators provide measurable signs of change or achievement, including both quantitative data (e.g. numbers of certificates, costs, disputes) and qualitative information (e.g. stakeholder perceptions, consistency of interpretation).

·Data sources identify the datasets and evidence streams used to answer each question.

·Points of comparison are references against which the answers to the evaluation questions are assessed.

The evaluation matrix was used as an organising tool throughout the evaluation process: it guided the structure of data collection, ensured full coverage of the intervention logic, and allowed for systematic comparison of evidence across themes and stakeholder groups. A full version of the matrix, including all evaluation questions and indicators, is provided in Annex III.

2.2. Grouping of effectiveness indicators

Effectiveness covers a wide spectrum of objectives from legal clarity and governance processes to safety outcomes and market functioning. To make this complex analysis comprehensible, evaluation questions were grouped into five thematic sections. The grouping reflects the internal structure of the regulatory framework and the logical sequence of actions and results. This approach is consistent with Tool #47 on proportionality and coherence in evaluations, which recommends thematic grouping where multiple questions address interrelated mechanisms.

2.2.1. Legal certainty, transparency and trust

Motivation:
Transparency is a core element of both the MDR and IVDR’s effectiveness. It underpins stakeholder trust, facilitates accountability, and supports informed decision-making by patients, professionals and industry. This section assesses to what extent the Regulations have increased openness, accessibility and reliability of information (e.g. through EUDAMED, SSCPs, UDI, and publication of expert opinions). In practice, transparency contributes indirectly to legal certainty (by clarifying regulatory expectations) and directly to trust (by allowing external verification).

Evaluation question covered:

·How successful have the MDR and IVDR been in contributing to its general objectives in terms of ensuring a high level of transparency on medical devices for all actors and citizens?  

2.2.2. Notified Bodies, conformity assessments and clinical evidence

Motivation:
The protection of health is achieved primarily through the robustness of pre- and post-market regulatory controls. This section focuses on the mechanisms that directly ensure safety and performance: the designation and oversight of notified bodies, the conduct and consistency of conformity assessments, and the generation of clinical and performance evidence.
Strong and predictable conformity assessments, based on sound clinical data and evidence, are the cornerstone of achieving the general objective of high health protection. This section therefore captures how well the MDR/IVDR translate the legislative ambition for safety into operational reality.

Evaluation question covered:

·How successful have the MDR and IVDR been in contributing to its general objectives in terms of ensuring a high level of protection of health for patients and users?

2.2.3. Market functioning and level playing field

Motivation: This section examines whether the Regulations have achieved their internal market objectives by enabling uniform application across Member States and reducing fragmentation. It covers elements such as market access, innovation and competitiveness, international cooperation, the availability of devices and the Regulation’s capacity to address specific needs of patients and users. The focus is on whether the Regulations have preserved the free movement of goods while maintaining safety standards—balancing regulatory control with efficiency and predictability.

Evaluation question covered:

·How successful have the MDR and IVDR been in contributing to its general objectives in terms of ensuring a smooth functioning of the internal market as regards medical devices? 

2.2.4. Post-market surveillance, vigilance and market surveillance

Motivation: Post-market surveillance (PMS), vigilance and market surveillance are integral to maintaining health protection over the lifecycle of devices. This section addresses post-market controls and the ongoing capacity of the system to detect and manage risks once devices are in use. Together, the sections ‘Notified Bodies, conformity assessments and clinical evidence’ and ‘Post-market surveillance, vigilance and market surveillance’ jointly operationalise the “health protection” objective across the device lifecycle—prevention before market entry, and monitoring after placement on the market.

Evaluation question covered:

·How successful have the MDR and IVDR been in contributing to its general objectives in terms of ensuring a high level of protection of health for patients and users?

2.2.5. Simplification and streamlined procedures

Motivation: Simplification and governance determine the capacity of the system to deliver on its objectives efficiently. Simplification refers not only to reducing administrative complexity but also to improving clarity of roles and procedures. Governance encompasses the functioning of coordination structures such as the Medical Device Coordination Group (MDCG) and the allocation of resources at EU level. Analysing these aspects together allows the evaluation to assess how institutional design influences effectiveness and whether the Regulations have promoted or hindered coherent implementation.

This section structure ensures thematic coherence and allows synthesis across questions with related causal pathways. It also provides a foundation for balanced aggregation of evidence in the overall scoring.

3. Analytical framework

3.1. Triangulation and mixed-methods approach

As no single source of evidence provides a complete picture, the evaluation applied a mixed-methods design combining quantitative and qualitative information, as recommended in Tool #48 (“Conducting the evaluation”). In addition to the general analytical framework described above, the evaluation applied a specific approach to assess efficiency and the balance between costs and benefits, consistent with the Better Regulation Toolbox (Tools #57–#61).

Triangulation served to increase the validity of findings by cross-verifying results from multiple independent sources. It was applied along three complementary dimensions:

·Horizontal triangulation: comparison of different stakeholder groups’ perspectives on the same issue - for example, contrasting manufacturer perceptions with those of notified bodies or national competent authorities (NCAs).

·Vertical triangulation: linking perceptions to empirical data, such as comparing survey opinions on costs with numerical data.

·Temporal triangulation: assessing consistency of evidence across time periods, particularly for indicators that span the transition from the previous Directives to the new Regulations.

In practice, triangulation meant that a finding was treated as robust only if it was supported by at least two distinct and independent sources. In some cases, this was not possible and in those cases the SWD outlines limitations or that the finding could not be robust. Divergences between sources were not averaged out but are clearly outlined in the text.

The mixed-methods approach also follows Tool #57 (“Methods to assess costs and benefits”), which recommends combining quantitative and qualitative evidence when full quantification is not feasible. Quantitative data offered measurable evidence of trends (e.g. average notified bodies fees, survey percentages), while qualitative inputs provided explanation and nuance, helping to interpret why stakeholders experienced impacts differently.

3.2. Scoring system

To integrate heterogeneous evidence into a coherent assessment, the evaluation of the five criteria applied a five-point ordinal scale, as recommended in Tool #47 (“Evaluation criteria and questions”). This system enables transparent synthesis while maintaining proportionality.

Scoring was performed sequentially:

1.Evidence was reviewed per evaluation question using the matrix.

2.Judgement criteria were assessed individually.

3.A narrative synthesis combined quantitative and qualitative elements.

4.An overall score was assigned, supported by short justifications.

The scores are interpretative, not mechanical. Percentages or averages from surveys were not automatically converted into scores; rather, they were weighed alongside qualitative information and triangulated findings. This qualitative scoring ensures that conclusions remain proportional to the strength of the evidence and avoid over-precision where data are limited.

The use of a unified scoring scale across all sections facilitated comparison between different impact areas - such as efficiency versus effectiveness - and enabled synthesis into a global assessment per evaluation criterion.

3.3. Efficiency analysis and assessment of costs and benefits

In addition to the general analytical framework described above, the evaluation applied a dedicated approach to assess efficiency and the balance between costs and benefits of the MDR and IVDR. This approach follows the Better Regulation Toolbox guidance (Tools #57–#61) on analysing costs, benefits and proportionality in evaluations.

The efficiency assessment examines how the objectives of the Regulations relate to the resources required to achieve them. It does not focus solely on whether compliance costs have increased compared to the previous Directives — an outcome that was expected given the higher ambition of the new framework — but also on whether these costs appear proportionate to the benefits achieved in terms of patient safety, public-health protection, transparency and market functioning.

3.3.1. Methodological approach

The efficiency analysis combines quantitative and qualitative methods, in line with the principles of the Better Regulation Guidelines, which recommend considering both measurable and non-monetary dimensions of efficiency.

Evidence was drawn from the targeted surveys of economic operators, notified bodies and national competent authorities, and of the EMA, as well as from the Call for Evidence, Public Consultation, position papers and reality check workshops. This evidence base made it possible on some of the topics to triangulate stakeholder perspectives while recognising the heterogeneity of responses.

Three analytical distinctions guided the approach:

1.Direct and indirect costs

oDirect costs are those explicitly incurred for compliance with regulatory obligations, including notified bodies fees for certification, preparation of technical documentation, clinical or performance evaluations, and establishment of post-market surveillance (PMS) systems.

oIndirect costs are less directly measurable but equally relevant, such as delays in certification leading to postponed market entry, opportunity costs where resources are diverted from innovation to compliance activities, and broader market effects such as devices availabilities, i.e. portfolio reductions or product withdrawals.

2.Monetary and non-monetary dimensions: Quantitative evidence was used wherever robust data were available — for example, average certification costs/fees. Many aspects of efficiency, however, are qualitative in nature, including administrative complexity, procedural delays and predictability of implementation, and many burdens are reported as resource diversion, added complexity or workflow delays. Quantitative and qualitative evidence were therefore treated as complementary: quantitative data provide order-of-magnitude indications, while qualitative inputs help interpret context and drivers. Benefits such as trust and transparency are captured only qualitatively.

3.Proportionality and distribution of impacts: Efficiency also depends on how costs and benefits are distributed among actors. Evidence suggests that small and medium-sized enterprises (SMEs) bear proportionally higher compliance costs than larger firms and that IVDR requirements pose specific challenges for laboratories and health institutions (e.g. in house devices). These distributional aspects were incorporated into the qualitative synthesis and the proportionality judgement.

4.The analysis also recognises the importance of distinguishing between transitional and structural costs, since the MDR and IVDR are not yet fully implemented but most stakeholders expect elevated costs to remain.

3.3.2. Typology of costs and benefits considered

The evaluation distinguishes several categories of costs and benefits, aligned with the intervention logic and evaluation matrix:

·Compliance costs for manufacturers and economic operators: including technical documentation, clinical and performance evaluations, notified bodies certification and maintenance fees, and PMS/vigilance activities.

·Compliance costs for healthcare providers (e.g. health institutions and laboratories): particularly documentation and validation requirements for in-house devices.

·Compliance costs for notified bodies, national competent authorities and EU structures: including notified bodies designation and oversight, staffing for national competent authorities, and EU-level, including IT and coordination costs (e.g. EUDAMED, MDCG).

·Indirect costs: market-level effects such as certification delays, opportunity costs of compliance, and consequences for device availability.

·Benefits: improved safety (health) and quality of devices, stronger transparency and traceability, more harmonised oversight across Member States, and increased trust in CE marking.

This typology structures the analysis and allows for a balanced comparison of costs and benefits across stakeholder groups.

3.3.3. Evidence base

Quantitative evidence on direct compliance costs was obtained primarily from the notified bodies and economic operators surveys. These provided indicative cost ranges and averages per certificate type, company size and where available, per device risk class.

Qualitative evidence was drawn from the consultation activities (Call for Evidence, Public Consultation, and position papers), which highlighted perceived cost drivers, administrative burdens and expected benefits such as enhanced safety and transparency.

The analysis relied on triangulation between these sources rather than direct aggregation. Quantitative estimates were treated as illustrative indicators, while qualitative information was used to interpret patterns and distributional effects.

3.3.4. Interpretation and proportionality

Given the incomplete data coverage and ongoing implementation of the Regulations, the efficiency analysis does not attempt to calculate a quantified cost–benefit ratio. Instead, it assesses whether the available evidence indicates proportionate relationships between resource inputs and achieved or expected outcomes.

Certain benefits - for example, improved safety, transparency and trust - are expected to materialise progressively over time. Conversely, several cost impacts, particularly for SMEs and niche manufacturers, are already visible. The evaluation therefore interprets efficiency results with caution and in a proportional manner, recognising that the overall balance between costs and benefits may evolve as implementation matures and as data become more comprehensive.

3.3.5 Limitations

The main limitations affecting the efficiency analysis are consistent with those of the broader evidence base:

·Limited comparability of cost data across actors and device types;

·Absence of a quantitative baseline under the previous Directives;

·Uneven representativeness of survey samples; and

·Ongoing implementation of MDR/IVDR provisions, which means that some costs are transitional, and some benefits have yet to materialise.

To mitigate these limitations, the evaluation relied on triangulation of evidence, basic plausibility checks of quantitative results and cautious, proportional interpretation of incomplete information. These steps helped maintain the credibility and balance of the efficiency assessment despite inherent data gaps

4. Limitations and mitigating measures

Recognising and managing limitations is essential for methodological transparency (see Tool #65, “Uncertainty and sensitivity analysis”). The main constraints affecting this evaluation were as follows:

1.Representativeness of open consultations: Participation in the public consultation and Call for Evidence was voluntary and self-selected. Results therefore represent stakeholder perceptions rather than statistically representative opinions. Their role in the analysis is to contextualise, not to quantify, broader stakeholder sentiment.

2.Heterogeneity and coverage of targeted surveys: The targeted surveys reached a high share of notified bodies and a broad sample of national competent authorities and economic operators, but coverage across device categories and Member States was uneven. Aggregated averages were therefore interpreted cautiously, and sensitivity checks were applied to control for outliers.

3.Absence of comprehensive baseline data: Systematic pre-2017 data on costs, benefits and administrative burdens are lacking, making precise before/after comparisons not possible. The evaluation instead used qualitative benchmarks drawn from previous studies and stakeholder recollections.

4.Attribution complexity: Developments in the medical device sector reflect a combination of regulatory, economic and external factors (e.g. COVID-19, also affecting supply-chain pressures). The evaluation therefore assesses the consistency of observed trends with the Regulations’ intervention logic rather than claiming strict causal attribution.

5.Incomplete implementation of certain provisions: Some elements, such as the full deployment of EUDAMED (and its mandatory use) and post-market data flows, are still under development. The evaluation can therefore only assess early evidence of their effects. Other provisions were not assessed as part of the evaluation scope e.g. those not yet implemented.

A key difficulty is the limited availability of reliable quantitative data despite extensive consultation. Important data gaps in the overall baseline include (but are not limited to), the number of devices and economic operators on the Union market, a complete number of certificates and device safety incidents.

-Economic operators and notified bodies surveys provide averages by certificate type, device class (in some cases), and company size, but these do not reflect the diversity of experiences, especially for niche, orphan or in-house devices whose costs were not directly captured under these surveys.

-Qualitative inputs from the Call for Evidence and position papers highlight issues such as administrative duplication and delays in Eudamed, disproportionate costs for SMEs, but they lack quantitative estimates of time spent on duplication or on cost proportion.

-Workshops, interviews and case studies provided valuable insights but not representative figures.

-Methodological challenges included inconsistent interpretation of questions, missing values, and confidentiality concerns that limited data sharing.

-In addition, there was no credible baseline measurement against which to compare the observed costs.

As a result, survey figures should be treated as indicative ranges rather than precise measurements. Triangulation across sources improves robustness but cannot resolve inconsistencies. The evaluation therefore places greater weight on qualitative evidence, which consistently points to structural cost increases, administrative duplication, and disproportionate impacts on SMEs. At the same time, it underlines the need for better cost data collection in future monitoring.

More details on the data gaps related to the effectiveness criteria is available in the scoring tables (see Annex VI).

Mitigating measures included:

·Triangulation of findings across the main evidence sources to confirm broad consistency and highlight any divergences;

·Basic plausibility checks of quantitative results to identify outlier values or clear inconsistencies;

·Explicit acknowledgement of data gaps and careful, proportionate interpretation where evidence was incomplete;

·Use of expert judgement to contextualise findings and ensure balanced conclusions. These safeguards ensured that findings remained credible and proportionate to the available evidence.

5. Uncertainty and robustness of results

The evaluation explicitly accounted for uncertainty at each analytical stage, following Tool #65. Sources of uncertainty were categorised as (a) data-related, (b) methodological, and (c) contextual.

·Data-related uncertainty stems from incomplete or inconsistent datasets, especially for cost indicators and country-level variations.

·Methodological uncertainty arises from the combination of quantitative and qualitative evidence, which requires interpretation.

·Contextual uncertainty reflects the dynamic implementation environment and evolving guidance under the Regulations.

The evaluation did not attempt to quantify uncertainty numerically. Instead, qualitative considerations were used to judge the relative strength of evidence. Where several sources pointed in the same direction, findings were treated as broadly robust; where evidence was limited or divergent, results were interpreted with caution and described as indicative.

6. Quality assurance and reliability of the evidence base

Quality assurance followed the standards of Tool #49 (“Format of the evaluation report”) and Tool #4 (“Evidence-informed policymaking”). Key safeguards included:

·Consistency with Better Regulation principles: All analytical work adhered to the principles of evidence quality, transparency, coherence, and proportionality.

·Traceability of evidence: Each finding in the SWD is linked to specific sources and indicators within the evaluation matrix, ensuring transparency and auditability.

·Internal coordination and review: Draft analytical sections were reviewed across relevant Commission services to ensure factual accuracy, methodological soundness and alignment with the evaluation matrix.

·Documentation and reproducibility: All analytical steps, including data compilation and scoring, were documented to facilitate verification.

This multi-layered quality process ensured that analytical conclusions are supported by verifiable evidence and consistent interpretation.

Despite data gaps and ongoing implementation, the overall evidence base is assessed as moderately to highly reliable. Several factors support this assessment:

·Breadth of coverage: The evaluation combines inputs from virtually all categories of stakeholders involved in the MDR/IVDR framework.

·Diversity of methods: The inclusion of both quantitative and qualitative sources ensures that no single dataset drives conclusions.

·Cross-validation: Triangulation across independent evidence streams enhances credibility.

·Transparency: Limitations, assumptions and uncertainties are explicitly stated and considered in the interpretation of findings.

While parts of the evidence base remain incomplete and certain data are still being collected as implementation progresses, the consistency of several key trends across independent sources provides a reasonable degree of confidence in the main findings. At the same time, some results should be interpreted with caution, particularly where data gaps persist or where the effects of the Regulations are still unfolding. Overall, the evaluation findings can be considered broadly reliable within the parameters of a complex and evolving regulatory environment.

For detailed answers to the evaluation questions related to the effectiveness criteria, see Annex VI. For the description of consultation activities referred to under ‘data source’, please refer to Annex V. For other terms, refer to the legend in Annex VI.