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
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Medicines Agency, exchange of information, harmonisation of standards, market approval, medical device, medical diagnosis, public health, quality standard, safety standard, smart technology

EN 

  EN 

   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 

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? . 4 

2.1. 

DESCRIPTION OF THE INTERVENTION AND ITS OBJECTIVES ............................. 4 

2.1.1.  Background to intervention (i.e. move from Directives to Regulations) ...... 4 

2.1.2.  Problems identified under the previous regulatory framework ..................... 4 

2.1.3.  Objectives and expected impacts of the new regulatory framework (i.e. 
Regulations) ................................................................................................................ 6 

2.2. 

POINT(S) OF COMPARISON ............................................................................... 9 

3.  HOW  HAS  THE  SITUATION  EVOLVED  OVER  THE  EVALUATION 
PERIOD? ....................................................................................................... 10 

3.1. 

3.2. 

CURRENT STATE OF PLAY ............................................................................. 10 

IMPLEMENTATION PROGRESS ........................................................................ 10 

4.  EVALUATION FINDINGS (ANALYTICAL PART) ................................. 14 

4.1. 

TO WHAT EXTENT WAS THE INTERVENTION SUCCESSFUL AND WHY? ............ 14 

4.1.1.  Effectiveness ................................................................................................ 14 

4.1.2.  Efficiency ..................................................................................................... 33 

4.1.3.  Coherence .................................................................................................... 41 

4.2. 

4.3. 

HOW DID THE EU INTERVENTION MAKE A DIFFERENCE AND TO WHOM? ....... 46 

IS THE INTERVENTION STILL RELEVANT? ...................................................... 48 

5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? ........... 50 

5.1. 

5.2. 

CONCLUSIONS ............................................................................................... 50 

LESSONS LEARNED ....................................................................................... 53 

ANNEX I:   PROCEDURAL INFORMATION ................................................... 55 

ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED ........... 57 

ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS 
ON ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION)
 ....................................................................................................................... 68 

ANNEX  IV.  OVERVIEW  OF  BENEFITS  AND  COSTS,  TABLE  ON 
SIMPLIFICATION AND BURDEN REDUCTION .................................... 83 

ANNEX V. STAKEHOLDERS CONSULTATION - SYNOPSIS REPORT ..... 95 

ANNEX VI. EFFECTIVENESS TABLES: EVIDENCE AND SCORING....... 117 

ANNEX VII. EXPLANATORY DIAGRAMS ................................................... 180 

ANNEX VIII. STAKEHOLDER MAPPING ..................................................... 189 

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List of acronyms and abbreviations 

AIMDD 
CE 
CFE 
CIE 
DG 
DG SANTE 
EFTA 
EQ 
EQM 
EU 
EUDAMED 
EUR 
HIV  
IA 
IMDRF 
IVD 
IVDD 
IVDR 
JAT 
MD 
MDD 
MDR 
MS 
NANDO 
NB 
NCAR 
QMS 
SME  
SWD 
UDI                      Unique device identification 

Active Implantable Medical Devices Directive 
Conformité Européenne 
Call for Evidence 
Clinical Investigation and Evaluation 
Directorate-General 
Directorate-General for Health & Food Safety 
European Free Trade Association 
Evaluation Questions 
Evaluation Questions Matrix 
European Union 
European database on medical devices 
Euro 
Human Immunodeficiency Virus 
Impact Assessment 
International Medical Device Regulators Forum 
In Vitro Diagnostic Medical Devices 
In Vitro Diagnostic Medical Device Directive 
In Vitro Diagnostic Medical Device Regulation 
Joint Assessment Team 
Medical Device 
Medical Device Directive 
Medical Device Regulation 
Member State 
New Approach Notified and Designated Organisations 
Notified Body 
National Competent Authorities Report 
Quality Management System 
Small and medium enterprises 
Staff Working Document 

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1. 

INTRODUCTION 

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 Europe1. 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 IVDs2. In 2025, 
the European medical device market is estimated at approximately 170 bn EUR, making it 
the second largest in the world following the US3. 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 devices6. 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 

1  World Health Organization, https://www.who.int/europe/news-room/fact-sheets/item/health-technologies.  
2 Rohr, U-P., et al., ‘The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report’, PLOS ONE, 11(3): 

e0149856, 2016, https://doi.org/10.1371/journal.pone.0149856.  

3 MedTech Europe website, Facts and Figures 2025 (Europe includes EU-27, the UK, Norway, Switzerland). 
4 Regulation (EU) 2017/745, OJ L 117, 5.5.2017, pp. 1–175, ELI: http://data.europa.eu/eli/reg/2017/745/oj. 
5 Regulation (EU) 2017/746, OJ L 117, 5.5.2017, pp. 176–332, ELI: https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng. 
6 See MDCG, MDCG 2021-25 Rev.1, October 2024: on the application of MDR requirements to ‘legacy devices’. 

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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  20247.  It  covers  both  the  basic  acts  as  well  as  implementing  and 
delegated acts8 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 Türkiye9. 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 

7 When available, data from 2025 was also used in the context of the targeted evaluation. 
8 European Commission website, Medical Devices – Sector – New Regulations.  
9 European Commission website, ‘Notice to stakeholders’ EU-Turkey Customs Union Agreement in the field of medical 

devices’, March 2022. 

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interpreting  the  results.  Annex  II  presents  the  methodology  applied,  its  robustness  and 
limitations.  

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) 

The Regulations were introduced to replace the previous regulatory framework consisting 
of three Directives10 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  Assessment11  
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 Assessment13 
have been re-defined into three major problems (see Figure 2 Revised intervention logic – 
Drivers & Problems): 

10  Council  Directive  90/385/EEC,  OJ  L  189,  20.7.1990,  pp.  17–36,  ELI: http://data.europa.eu/eli/dir/1990/385/oj; 
Council Directive 93/42/EEC, OJ L 169, 12.7.1993, pp. 1–43, ELI: http://data.europa.eu/eli/dir/1993/42/oj; Council 
Directive 98/79/EC, OJ L 331, 7.12.1998, pp. 1–37, ELI: http://data.europa.eu/eli/dir/1998/79/oj. 

11 European Commission, Staff Working Document Impact Assessment on the revision of the regulatory framework for 
medical devices, 2012. ERL: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=swd:SWD_2012_0273.  

12 Regulation EU 282/2014, OJ L 86, 21.3.2014, pp. 1–13, ELI: http://data.europa.eu/eli/reg/2014/282/oj.  
13 The problems identified: (1) Oversight of notified bodies, (2) Post-market safety, (3) Regulatory status of products, 
(4) Lack of transparency and harmonised traceability, (5) Access to external expertise, (6) Unclear and insufficient 
obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet 
sales, (7) Management of the regulatory system. 

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Problem 1 – Insufficient safety of some medical devices  

By late 2011, the medical device EU regulatory framework faced intense scrutiny from 
both the media14 and the political spheres15, 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 
replacements16,17 or urogynaecological surgical meshes18,19. 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  monitoring20  of 
notified bodies by competent authorities and a lack of requirements for medical devices 
without an intended medical purpose, to determine borderline21 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  

14 See for example: Reuters, Special Report: The French breast implant scandal, 2 February 2012. 
15 European Parliament Resolution of 14 June 2012: P7_TA-PROV(2012)0262 (2012/2621(RSP)). 
16 BfArM website, Field Safety Notice for the DePuy metal-on-metal join replacements (August 2010). 
17 SCENIHR, Safety of Metal-on-Metal joint replacements with a particular focus on hip implants, Expert Opinion, 24 

September 2014.  

18 U.S.  Food and Drug Administration (FDA), Urogynecologic surgical mesh: Update on the Safety and Effectiveness 

of Transvaginal Placement for Pelvic Organ Prolapse, July 2011.  

19 SCENIHR, Safety of surgical meshes used in urogynaeocological surgery, Expert Opinion, 3 December 2015 
20  Of  note: 

(EU)  920/2013  OJ  L  253,  25.9.2013,  pp.  8–19,  ELI: 
http://data.europa.eu/eli/reg_impl/2013/920/oj introduced clearer legally binding requirements on the designation 
and monitoring of notified bodies designated to assess medical devices (excludes IVDs).  

Implementing  Regulation 

21  ‘Borderline  products’  are  those where  it  is  not  clear  from  the  outset  whether  they  fall under  the Medical  Devices 

Regulation. See for instance: MDCG Document, MDCG 2022 – 5 Rev. 1, October 2024. 

5 

 
 
 
Due  to  the  limited  scope  of  the  European  databank  on  medical  devices22  (Eudamed  2) 
which was not publicly accessible23 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  - 

22 Eudamed 2 (link is no longer available). 
23 See SWD(2012) 273 final, section 2.2.4.  

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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 201524. 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: Technopolis25) 

24 United Nations, The 17 Goals, UN website. SDG 3: Ensuring healthy lives and promote well-being for all at all stages; 
SDG 9: Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation. 
25 Technopolis, Study supporting the targeted evaluation of the MDR and IVDR - Final report, December 2025, under 

preparation.  

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Figure 2 – Revised intervention logic  

8 

 
 
 
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  transparency26.  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 scene27. 

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  manufacturers28.  Furthermore,  some  evidence 

26 See SWD (2012) 273 final, page 19. 
27 See SWD (2012) 273 final, page 10 and the European Parliament Resolution of 14 June 2012 (note 15, page 5). 
28 See SWD (2012) 273 final, page 15. 

9 

 
 
 
(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 withdrawals29. 
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  capacity30.  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.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? 

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  application31  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 

29 Regulation of Medical Devices in the United States and European Union, Daniel B. Kramer, M.D., Shuai Xu, M.Sc., 

and Aaron S. Kesselheim, M.D., J.D., M.P.H. DOI: 10.1056/NEJMhle1113918, VOL. 366 NO. 9. 

30 See SWD (2012) 273 final, page 16. 
31 Regulation (EU) 2020/561, OJ L 130, 24.4.2020, pp. 18–22, ELI: http://data.europa.eu/eli/reg/2020/561/oj.  

10 

 
 
 
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 832): to December 2027 for high-risk devices, December 2028 for medium risk devices. 
These  extended  transition  periods  were  however  subject  to  several  conditions33.  The 
legislative amendments also removed the sell-off period34 for legacy devices. Similarly, 
the IVDR transitional periods were extended twice35,36, 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 delays3736. In addition, an advance warning 
mechanism for supply interruptions and discontinuations was introduced38 (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 acts39. 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  format40,  establishing  expert  panels  on 
orphan  devices41,  as  well  as  common  specifications42.  Planned  measures  include  the 
expansion  of  the  list  of  well-established  technologies  (WET)43  and  on  the  uniform 

32 Figure 7 and 8 in Annex VII explain the risk classification of devices under the MDR and IVDR respectively.  
33 Regulation (EU) 2023/607, OJ L 80, 20.3.2023, pp. 24–29, ELI: http://data.europa.eu/eli/reg/2023/607/oj.  
34 This removed the need to dispose of safe medical devices that are already on the market but not yet with the final user.  
35 Regulation (EU) 2022/112, OJ L 19, 28.1.2022, pp. 3–6, ELI: http://data.europa.eu/eli/reg/2022/112/oj.  
36 Regulation (EU) 2024/1860, OJ L, 2024/1860, 9.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1860/oj.  
37 See note 35, page 11. 
38 See note 35, page 11. 
39 See note 8, page 3. 
40  Commission 

Implementing  Regulation 

2025/1234,  OJ  L, 

26.6.2025,  ELI: 

2025/1234, 

(EU) 

http://data.europa.eu/eli/reg_impl/2025/1234/oj. 

41 European Commission website, Medical Devices – Expert panels. 
42 European Commission website, Medical Devices – In Vitro Diagnostics – Common specifications.  
43 European Commission website, Medical devices – expansion of the list of well-established technologies. 

11 

 
 
 
application  of  requirements  for  notified  bodies44.  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 established46. 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 Centre47 
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  panels49.  At  the  national  level,  Member 
States  have  duly  designated  competent  authorities50  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 Commission51. Finally, notified 
bodies52 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-Med53) 
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  202554.  Building  on  this,  the  COMBINE 
programme55 looks at coordinated assessment of clinical investigations and performance 
studies, combined with clinical trials of medicinal products.  

Scientific structures: expert panels56 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. 

44 European Commission website, Medical devices –uniform application of the requirements for notified bodies. 
45 European Commission website, Medical Devices – Topics of Interest – Harmonised standards.  
46 European Commission website, Medical Devices – Sector - Coordination and Governance.  
47  Commission 

Implementing  Regulation 

2023/2713,  OJ  L, 

2023/2713, 

(EU) 

6.12.2023,  ELI: 

http://data.europa.eu/eli/reg_impl/2023/2713/oj.  

48 European Medicines Agency website, Medical device expert panels. 
49 JRC, Handover of expert panels on medical devices and in vitro diagnostics from the Commission’s Joint Research 

Centre (JRC) to the European Medicines Agency (EMA), News article, 3 March 2022.  

50 National competent authorities are designated by Member States in accordance with Article 101 MDR. 
51 European Commission website Medical Devices - Dialogue between interested parties – Medical Device Coordination 

Group Working Groups. 

52 European Commission website, Medical Devices – Topics of Interest – Notified bodies for medical devices.  
53 European Commission website, Medical Devices - Dialogue between interested parties – Overview - Notified Body 

Coordination Group (NBCG-Med). 

54 European Commission website, Medical Devices – Clinical investigations and performance studies - Pilot coordinated 

assessment for CI/PS.  

55 European Commission website, Medical Devices – Topics of Interest - The COMBINE programme.  
56 European Commission website, Medical Devices – Expert Panels - Overview. 

12 

 
 
 
In  2025  another  call  for  EURLs  has  been  launched  in  two  waves57  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)  system58 
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  digitalisation59.  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 modules61. 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 actors62). 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 – 

57 See note 47, page 12. 
58 European Commission website, Medical Devices – Topics of Interest - Unique Device Identifier - UDI - UDI Issuing 

Entities. Article 27 MDR establishes the UDI system. 

59  European  Commission,  Unique  Device  Identification  (UDI)  System  under  the  EU  medical  devices  Regulations 

2017/745 and 2017/746, 2020. 

60  European  Commission  website,  Medical  Devices  –  Topics  of  Interest  -  European  Medical  Devices  Nomenclature 

(EMDN). 

61 See Annex VII Figure 2. 
62 European Commission website,  EUDAMED working group under the MDCG. 
63 Commission Decision (EU) 2025/2371, OJ L, 2025/2371, 27.11.2025ELI: http://data.europa.eu/eli/dec/2025/2371/oj, 

see also  European Commission website, EUDAMED roadmap. 
64 European Commission website, EU4Health annual work programmes.  

13 

 
 
 
(Notified  Body  Increased  Capacity)  and  the  horizon  scanning  projects65.  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 implementation66.   

4.  EVALUATION FINDINGS (ANALYTICAL PART) 

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.  

4.1.1.1.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 

65  Nobocap, BRINGING TOGETHER EUROPE TO UNLOCK MEDICAL DEVICE REGULATIONS & THE AI ACT 
FOR INNOVATORS AND SMES IN EUROPE, October 2025. URL: https://nobocap.eu/ and Hadea, EU4Health 
prior information notice: horizon scanning system for medical devices & in vitro diagnostic medical devices, 3rd 
June  2024.  Url:    https://hadea.ec.europa.eu/news/eu4health-prior-information-notice-horizon-scanning-system-
medical-devices-vitro-diagnostic-medical-2024-06-03_en.  
66 European Commission website, MDCG minutes September meeting. 

14 

 
 
 
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 
opinions67. 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. 

implementation, 

The  guidance  volume  under  the  Regulations  is  high,  with  over  100  MDCG  guidance 
documents & FAQs68 issued since 2017 which were expected to facilitate implementation. 
Stakeholders have however reported on-going challenges with clarity and consistency in 
the  Regulation’s 
inconsistent 
interpretations  by  notified  bodies  and  national  authorities  and  vague  or  impractical 
guidance69. Only 40% of public consultation respondents believe MDCG guidance brings 
legal clarity70 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 predictability71. Evidence therefore suggests that operational legal 
certainty remains limited. 

including  unclear  definitions, 

The  Regulations  introduced  various  EU  level  procedures  including  on  classification 
disputes  and  product  qualification,  aiming  to  enhance  legal  certainty72.  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 

67 Targeted national competent authority survey, conducted in the context of the Targeted Evaluation of the MDR/IVDR. 

Hereafter ‘Targeted national competent authority survey’.  

68 European Commission website, Medical Devices – Sector - New Regulations-  Guidance - MDCG endorsed documents 

and other guidance. These guidance documents are non-legally binding.  
69 Position papers, Call for evidence, Reality check workshop with manufacturers. 
70 European Commission website, public consultation – EU rules on medical devise and in vitro diagnostics – targeted 

evaluation. Hereafter ‘Public consultation’: 41.2% agree for MDR and 39.8% for IVDR. 

71 European Commission website, call for evidence – EU rules on medical devices and in vitro diagnostics – targeted 
evaluation . Hereafter ‘Call for evidence’. 112 respondents: 48 from Company/Business, 20 from Health Providers, 
18 from Business Associations, 10 from EU Citizens, 6 from Academic/Research Institutions, 4 from NGOs, 4 from 
Other, 2 from Public Authorities. 

72 Classification disputes: Article 52(3) and (4) MDR, Article 47(3) and (4) IVDR. Qualification matters: Article 4 MDR. 

15 

 
 
 
borderline and qualification issues73 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 
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 
improvements75  are  needed  for  the  Regulations  to  realise  their  full  potential  for  legal 
certainty and support a smooth functioning of the internal market. 

improved 

the 

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 
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. 

transparency—are  still 

thereby 

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 low76, whilst most 
countries with MDR/IVDR notified bodies have published summary monitoring reports77. 

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 

73 Exchange of information between medical device competent authorities on borderline and classification cases Helsinki 

Procedure 2021, version 23 June 2021.  
74 European Commission, internal sources.  
75  Call  for  Evidence  –  324  respondents:   119 Company/Business from,  55  from  Health  Providers, 44  from  EU 
Citizens, 35 from Business  Associations, 21  Other, 17  from Academic/Research Institutions, 10  from non  EU-
citizens, 8  from  NGOs,  6  From  Public  Authorities, 3  from  Trade  Unions, 3 from Patient  Organisations, 2 
from Notified Bodies, 1 from Consumer Organisations. 

76 e.g.  publication  via  manufacturer  websites.  ‘Economic  operator  survey’  conducted  in  the  context  of  the  Targeted 
Evaluation  of  the  MDR  and  IVDR,  hereafter  ‘Economic  operator  survey’:  for  pre-market  clinical  information, 
SS(C)P and clinical investigation: for MDs, less than half of the clinical investigation reports and summaries are 
published; for IVDs, only 0.4% of performance studies reports and summaries are published. 

77 European Commission website, Medical Devices – Topics of Interest – Notified Bodies - Member States summaries of 
the national designating authority annual reports - 2024  (18 out of the 20  countries that have Notified Bodies 
submitted the MDR summary, and 7 of 12 submitted the IVDR summary). 

16 

 
 
 
on  the  market78,  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 implementation79. 
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 devices80. Flexibility for future such accommodations could be considered.  

The gradual rollout81 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 
priority82.  They  also  pointed  to  the  resulting  limited  access  to  public  information  and 
incomplete share of data, thus highlighting the gaps in transparency83. 

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  exists84,  citing 
limited SSCP availability and non-transparent notified body processes. On the same note, 
healthcare  professionals  highlighted  insufficient  transparency  in  clinical  data85,  and  on 
notified body processes, including unclear timelines and fees8683. 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 limited87. 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 use88. 

78 The MDR/IVDR UDI requirements, are only applicable to Regulation compliant devices, and not ‘legacy devices’ in 
transition. MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ 
and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC. 
Only when the EUDAMED functionality for UDI registration is mandatory and transition period ends, will UDI be 
fully applied to all devices. 

79 Call for Evidence – 22 out of 121 respondents: 7 Business, 6 Health Providers, 5 Business Associations, 2 EU Citizens, 

1 NGO, 1 Other. 

80 European Commission website, MDCG 2025-7 Position Paper Timelines MUDI-DI. 
81 Regulation (EU) 2024/1860 OJ L, 2024/1860, 9.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1860/oj 
82  Call  for  Evidence  –  34  out  of  121  respondents:  10  Business,  8  Health  Providers,  6  Business  Associations,  4  EU 

Citizens, 3 NGOs, 2 Academics, 1 Public Authority. 

83 Position papers. 
84 Public consultation, 75.2% disagree for MDR and 77.8% disagree for IVDR. 
85  Call  for  Evidence  –  34  out  of  121  respondents:  10  Business,  8  Health  Providers,  6  Business  Associations,  4  EU 

Citizens, 3 NGOs, 2 Academics, 1 Public Authority. 

86 Call for Evidence – 28 out of 121 respondents: 12 Business, 8 Business Associations, 3 EU Citizens, 2 NGOs, 2 Non-

EU Citizens, 1 Other.  

87  Call  for  Evidence  –  34  out  of  121  respondents:  10  Business,  8  Health  Providers,  6  Business  Associations,  4  EU 

Citizens, 3 NGOs, 2 Academics, 1 Public Authority. 
88 See note 69, page 15, for other sources confirming this.  

17 

 
 
 
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 Directives89. 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  professionals90).  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 view91. 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 interpretation92. 

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  regulation93.  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 evidence94. 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. 

89  Notably  safety  of  Poly  Implant  Prothèse  (PIP)  Silicone  Breast  Implants,  Metal-on-Metal  joint  replacements,  and 

surgical meshes used in urogynaecological surgery. 

90 Public consultation (answers to the PC are not statistically representative of the EU population, as respondents with 
negative perceptions might have a higher participation rate). Economic operators: around 60% (MD) and 65% (IVD) 
disagree that the Regulations have strengthen trust, while for healthcare professionals: 58% for MDs and 77% for 
IVDs share this view. 

91 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. Hereafter ‘study on governance’.  
92  Call  for  Evidence  –  87  respondents:  27  Company/Businesses,  16  EU  citizens,  13  Health  Providers, 9  Business 
Associations, 6 other, 4 non-EU Citizen, 3 NGOs, 3 Academic/Research Institutions, 2 Consumer Organisations, 2 
Patient  Organisations, 1  Public  Authority and  1  Notified  Body.  Questions  5.50  and  6.50  in  Public  consultation: 
“What do you see as the most important barrier to building trust in the regulatory system of medical devices in the 
EU?”. For MDR, more than 85% respondents and the IVDR approximately 80% shared these concerns. 

93 Call for Evidence – 18 out of 87 respondents: 6 from Health Providers, 5 from Company/Business, 4 from Business 

Associations, 2 from NGOs, 1 from Public Authority. 

94 Call for Evidence. 

18 

 
 
 
4.1.1.2.Notified  bodies,  conformity  assessment  procedures  and  clinical 

evidence 

The  Regulations  are  based  on  the  New  Legislative  Framework95,  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  enhanced96  (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 

95 Decision No 768/2008/EC, OJ L 218, pp. 82–128, ELI: http://data.europa.eu/eli/dec/2008/768(1)/oj.  
96 Call for evidence, 211 entries referenced requirements for robust clinical evidence. 
97 European Commission, internal sources.  

19 

 
 
 
body, which are approved by the authority98, with a median of 245 days for MDR, 194 
days for IVDR, and the Joint Assessment Team’s99 (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  delay100  (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-going101.  In  terms  of  the  designation  scope  for  notified 
bodies (i.e., device types they are authorised to certify102), notified bodies have obtained 
92% of medical device codes and 97% of IVD codes that they applied for103. 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 

98 On-site assessment of Corrective and Preventative Action (CAPA). 
99 Joint Assessment Team (JAT) as described in Article 39(3) MDR and Article 35(3) IVDR. 
100 European Commission website on the New Approach Notified and Designated Organisations (NANDO) Information 
System: see the list of MDR and IVDR designated notified bodies: As of October 2025, 51 MDR-designated notified 
bodies (6 of which that were not designated under the Directives) and 19 IVDR-designated notified bodies (2 of 
which that were not designated under the Directives) were registered in the NANDO Information System. 

101 European Commission website, Overview of CABs/NBs at each stage of the designation process. 
102 See list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as 
notified  bodies  (Commission  Implementing  Regulation  (EU)  2017/2185,  OJ  L  309,  24.11.2017,  pp.  7–17)  and 
Coverage of designation codes by MDR/IVDR notified bodies (European Commission website, June 2025). 

103 European Commission, internal sources.  

20 

 
 
 
central oversight. Coordination takes place at EU level through the MDCG, the subgroup 
for notified body oversight (NBO104, with 21 meetings, 29 MDCG-endorsed documents105), 
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  system106.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 
activities107.  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  dialogue110  (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 investigations111. 

104 See Terms of reference of the MDCG Working Group, Notified Bodies Oversight (NBO), 2018.  
105 European Commission website, 29 MDCG-endorsed documents on Notified Bodies and 3 , NBCG-Med documents. 
106 Position papers, Call for Evidence. 
107 European Commission website – Study supporting the monitoring of availability of medical devices on the EU market. 
The study has been contracted to a consortium led by the Austrian National Public Health Institute (Gesundheit 
Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting, 12th Notified Body survey, questions 
for the Targeted Evaluation. Hereafter ‘Notified body survey’.  

108 See note 107, page 21; also reported in Economic operator survey. 
109 Economic operator survey.  
110 MDCG, Questions and answers: Requirements relating to notified bodies Revision 5, MDCG 2019-6 Rev5, February 

2025.  

111 European Commission: Directorate-General for Research and Innovation, Cavicchi, B., Florindi, F., Gilbert, S. and 
Vuorinen,  H., EU  R&I  policy  as  an  enabler  of  MedTech  innovation  –  Addressing  development  and  market 
integration 
2025  
Publication 
challenges, 
https://data.europa.eu/doi/10.2777/4917399. 

European 

Office 

Union 

the 

of 

21 

 
 
 
There has been a negative evolution in the perceptions among economic operators on the 
level  of  harmonisation  of  notified  bodies’  conformity  assessment  activities112,  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 available113, 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 
stable114,  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  accountability115.  In 
addition, the number of clinical investigations for research purposes, post-market clinical 
follow-ups (PMCFs) and performance studies have all increased116. 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 
Clinical117 and Performance procedure118 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 requirements119,120, 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. 

112 Public consultation, call for evidence, position papers, and reality check workshop. 
113 European Commission, Published fees on notified bodies websites for MDR and IVDR related services’. 
114 Targeted national competent authority survey. 
115 Workshop with MDCG stakeholders on 03 April 2025 
116 Targeted national competent authority survey. 
117 Clinical Evaluation Consultation Procedure (CECP), Article 54 MDR - https://health.ec.europa.eu/medical-devices-

expert-panels/experts/list-opinions-provided-under-cecp_en. 

118 Performance Evaluation Consultation Procedure (PECP), Article 48(6) IVDR - https://health.ec.europa.eu/medical-

devices-expert-panels/experts/list-views-provided-and-ongoing-consultations-under-pecp_en. 

119 Reality check workshop with manufacturers. 
120 See note 111, page 21. 

22 

 
 
 
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. 

4.1.1.3.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 
prices122. 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 US123. 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  approved124.  The  steady  patenting  performance, 
together  with  the  EU’s  strong  export  position125,  indicate  a  continued  capacity  for 
innovation,  commercial  attractiveness  and  research  and  development  investment126. 
However, evidence of this on the market is not yet apparent. 

121 MedTech Europe website, Facts and Figures 2025 (see footnote 3 page 2). 
122 See note 121, page 23. 
123 European Patent Office, Patent Index 2024.  
124 See note 121, page 23. 
125 Europe had a medical devices trade balance of 5 billion EUR in 2024, with its main trade partners being  the US, 

China, Japan, and Mexico. See note 121, page 23. 

126  Europe’s  strong  incentives,  skilled  talent  pool  and  growing  support  for  entrepreneurship  make  it  an  attractive 
environment for medtech innovation and R&D investment, based on MedTech Europe - Europe’s Attractiveness 
for Innovation, State of Play and Recommendations. 

23 

 
 
 
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 groups128 and continued implementation of IMDRF 
guidance129. While the number of bilateral operational agreements has declined since 2017, 
progress  includes  updates  to  the  EU  –  Turkey  Custom  Union  for  medical  devices130. 
Despite continued reliance on EU MDR/IVDR certificates by other jurisdictions (125 for 
medical devices, 45 for IVDs131), 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 audits133 – 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  innovation134.  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  IVDR135.  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  SMEs136. 
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 
availability137 and highlight the need to develop structured, harmonised early scientific and 
regulatory dialogue frameworks.138   

127 IMDRF website, https://www.imdrf.org/. 
128 IMDRF, Working Groups 3 working groups are led by a representative of the EU or of an EU Member States. 
129  IMDRF  Management  Committee,  IMDRF  Document  Implementation  Report,  IMDRF/MC/N84  FINAL:2025 

(Edition 2), 1 September 2025.  

130  See note 9, page 3. 
131 Public Consultation: number of other jurisdictions relying on EU CE marking for MD and IVD. 
132 MDSAP global, Auditing Organisations. 
133 See note 107, pg 21. 
134 Public consultation: MD: 86.6% disagreed and strongly disagreed; IVD: 85.8% disagreed and strongly disagreed. 
135 Study on governance.  
136 Call for Evidence, Study on governance, Position Papers. 
137 Study on governance ‘“[…] when it comes to specific initiatives for fostering innovation, stakeholders often pointed 
to  the  need  for  specific  regulatory  pathways  for  innovative  devices,  taking  inspiration  from  for  example  the 
‘Breakthrough Devices Program’. 

138  See  note  111,  page  21,  stakeholder  recommendations  for  ‘Centres  for  Excellence  in  Regulatory  Science  and 

Innovation’. 

24 

 
 
 
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  stakeholders139  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  procedures140.  Healthcare 
professionals, insurers, and EU bodies advocate for more centralised processes and fees141. 

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  increased142 
(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 Directives143. Transition progress remains uneven as 14/50 notified bodies stated 

139 Call for Evidence – 112 out of 176 respondents: 48 from Company/Business, 22 from Business Association, 15 from 
Health Provider, 10 from EU Citizen, 6 from Other, 5 from Academic/Research Institution, 3 from NGO, 2 from 
Public Authority, 1 from Trade Union. 

140 Call for Evidence, Position papers. 
141 Call for Evidence, Position papers. 
142 See note 107, pg 21. Surveys conducted from February 2021 – October 2024.  
143 This is compared to 25,034 MD/AIMD and 1,551 IVD certificates issued under the Directives. 

25 

 
 
 
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 risk145 have been made under the prior 
notification obligation for manufacturers (Article 10a) applicable since January 2025146. 
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 devices147, 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 availability148, 
with  recurring  reasons149  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 hospitals151. Although 
citizens  are  least  likely  to  indicate  problems152,  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 
implants153.  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 
products154, thus impacting market availability. 

In  this  context,  and  especially  for  orphan  devices  which  are  critical  for  patients  with 
risk  of 
limited 

treatment  alternatives,  stakeholders  consistently  highlight 

the 

144 See note 107, pg 21. 
145 Since January 2025: approximately one third of 40 notifications received concern devices with no alternatives. 
146 European Commission,  The information obligation in case of interruption or discontinuation of  supply of certain 

medical devices and in vitro diagnostic medical devices, Q&A, Rev 1, December 2024.  

147 Regulation (EU) 2022/123, OJ L 20, 31.1.2022, pp. 1–37, ELI: http://data.europa.eu/eli/reg/2022/123/oj.  
148 Call for Evidence – 393 responses highlighted reduced availability under the MDR/IVDR: 139 company/businesses, 
76 health providers, 62 EU citizens, 40 business associations, 22 other, 18 academic/research institutions, 9 NGOs, 
8  non-EU  citizens,  7  public  authorities,  5  patient  organisations,  3  consumer  organisations,  2  trade  union, and 
2 notified bodies. 

149 Economic operator survey. 
150 Economic operator survey. 
151 Position paper. This is also confirmed in the Study supporting the monitoring of availability of medical devices on the 
EU market. The study has been contracted to a consortium led by the Austrian National Public Health Institute 
(Gesundheit  Österreich  GmbH/GÖG),  in  collaboration  with  Areté  and  Civic  Consulting,  Survey  on  the  Health 
Service Providers. 

152  Public  consultation:  15  out of  16  EU  citizens  indicated  that in  the  past  3  years they  did  not  have  issues  with  the 

availability of devices they wanted to or should use. 

153 Study on governance, Position papers, Economic operator survey. 
154 Position papers. 

26 

 
 
 
discontinuations (see Annex V), with over half of manufacturers having planned portfolio 
reductions155. 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 IVDs156. 
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  critical157.  Overall,  132  out  of  393  stakeholders 
reported  disproportionate  impacts  on  SMEs  and  niche  products158,  confirming  market 
pressures and compliance costs continue to threaten the availability of orphan devices159. 
To address  this challenge, in  addition  to clarifications in  an MDCG guidance160 and an 
orphan device support grant161, the EMA has launched a pilot programme to support the 
development  and  assessment  of  orphan  medical  devices162.  Stakeholders  underline 
however the gap in dedicated regulatory pathways163 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 burdensome164 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 oversight165. Due to the high regulatory burden, 75% of such tests 
were  estimated  in  one  evidence  source  by  stakeholders  to  be  discontinued166.  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 

155  MedTech  Europe,  MedTech  Europe  Survey  Report  analysing  the  availability  of  Medical  Devices  in  2022  in 

connection to the Medical Device Regulation (MDR) implementation, 14 July 2022. 

156 MedTech Europe, MedTech Europe IVDR & MDR Survey Results 2024, Public Report, December 2024. 
157 Study on governance.  
158 Call for Evidence – 132 out of 393 respondents: 54 from Company/Business; 26 from Health Providers; 20 from EU 
Citizens; 16 from Business Associations; 8 from Other; 6 from Academic/Research Institutions; 2 from NGOs 

159 Study on governance, Call for Evidence, Position papers. 
160 MDCG, Clinical evaluation of orphan medical devices, MDCG 2024-10, June 2024. 
161 EU Funding & Tenders Portal (2023), EU Funding & Tenders Portal (2025). 
162 For further information see the EMA website, New pilot programme to support orphan medical devices. 
163 Position papers. 
164  Call  for  Evidence  –  72  out  of  124  respondents:  45  from  Health  Providers,  10  from  Company/Business,  7  from 
Business Associations, 5 from EU Citizens, 3 from Academic/Research Institutions, 1 from Patient Organisations, 
and 1 from NGOs. 

165 Call for Evidence – 88 out of 275 respondents: 40 from Company/Business, 20 from Business Associations, 10 from 
Health Providers, 8 from EU Citizens, 5 from NGOs, 3 from Academic/Research Institutions, 2 from Others 

166 Reality check with healthcare professionals, users and patients.  

27 

 
 
 
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 alternatives167 .  

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 need168. 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.  

4.1.1.4.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 

167 Vermeersch, Pieter., Van Aelst, Tobias and Dequeker, Elisabeth M.C., The new IVD Regulation 2017/746: a case 
study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of 
freedom laboratories have to use lab-developed tests to improve patient care, Clinical Chemistry and Laboratory 
Medicine (CCLM), vol. 59, no. 1, 2021, pp. 101-106. https://doi.org/10.1515/cclm-2020-0804. 

168 See Articles 59 MDR/54 IVDR. Derogations can be granted at national or in exceptional circumstances, at EU level. 
169 European Commission, internal sources. 
170 Public consultation. 

28 

 
 
 
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  FSCA173.  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 Regulations174. 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 

171 Public consultation. 
172 European Commission, internal sources, targeted national competent authority survey. 
173 Public consultation: only 26/170 or 15.3% indicated that it had increased; only 40/170 or 23.5% indicated that at least 

one MIR had led to a FSCA. 

174 European Commission, internal sources  

29 

 
 
 
changed  since  the  application  of  the  Regulations,  with  less  than  a  quarter  of  national 
inspection  reports  having  a  corresponding  final  inspection  report175.  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  actions176,177. 
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.  

4.1.1.5.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 decentralisation178. Intensive coordination has been needed between EU level 

175 European Commission, internal sources and the targeted national competent authority survey. 
176 European Commission website, EU funding & Tenders  Portal,  Joint Actions on Market Surveillance (JAMS) 2.0.  
177 European Commission website, Joint Actions on Compliance of Products in the EU and EFTA countries (JACOP). 
178 European Commission website, Medical Devices – Sector - Coordination and Governance. 

30 

 
 
 
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 
authorities179 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  clear180.  Moreover,  only  32%  of  healthcare 
institutions, professionals or patient organisations, and 34% of economic operators or trade 
associations, agreed that collaboration among actors is good181. 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  years182.  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 concern183. 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  solution184.  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 

179 European Commission website, European Database on Medical Devices - National designating authorities. 
180 Study on governance. 
181 See note 180, page 30. 
182 See note 180, page 30. 
183 Reality check workshop with manufacturers.  
184 Position papers. 

31 

 
 
 
manufacturers185.  Though  some  devices  can  be  exempt  from  certain  Regulation 
requirements  by  achieving  well-established  technology  designation,  this  list  currently 
contains  only  12  technologies186  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  cited187  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  consulted189. 
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  technologies190.  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 requirements191. 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 implemented193. 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 

185 Call for Evidence – 76 out of 318 respondents: 40 from Company/Business, 15 from Health Providers, 10 from EU 

Citizens, 6 from Business Associations, 3 from Academic/Research Institutions, 2 from NGOs. 

186 See Article 61(6)(b) MDR. 
187 Call for Evidence. 
188 Call for Evidence, Position Papers. 
189 Public consultation. 
190 Call for evidence. 
191 Public consultation. 
192 European Commission website,  Commission simplifies instructions for use of medical devices to further digitalise 

healthcare systems, News Announcement, 25 June 2025. 

193 Commission Implementing Regulation (EU) 2021/2226, OJ L 448, 15.12.2021, pp. 32–38j. 

32 

 
 
 
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 purpose194. 

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. 

4.1.1.6.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).  

194 Commission Implementing Regulation (EU) 2025/1234, OJ L, 2025/1234, 26.6.2025. 
195  11  guidance  documents  and  common  specifications  were  developed  for  SARS-CoV-2:  European  Commission 

website, Guidance - MDCG endorsed documents and other guidance – COVID-19. 

33 

 
 
 
4.1.2.1.Manufacturers: Costs & Benefits 

Costs - Pre-market clinical/ performance evaluation: Manufacturers reported196 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 Ir197 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  representatives198 
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 
burdens199, 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.  

196 Economic operator survey. 
197 Class I reusable surgical instruments. 
198 Call for Evidence – 52 out of 211 respondents: 30 from Company/Business, 12 from Business Association, 5 from 

Health Providers, 3 from EU Citizens, 2 from NGOs.  

199 Call for Evidence – 132 out of 393 respondents: 54 from Company/Business; 26 from Health Providers; 20 from EU 
Citizens; 16 from Business Associations; 8 from Other; 6 from Academic/Research Institutions; 2 from NGOs. 
200 Call for Evidence – 87 out of 318 respondents: 50 from Company/Business, 15 from Health Providers, 10 from EU 

Citizens, 7 from Business Associations, 3 from Non-EU Citizens, 2 from Academic/Research Institutions. 

34 

 
 
 
For the MDR, for one type of QMS certificate201, 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 certificate202, 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  certificates203,  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  certificates204,  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 

201 QMS certificates under Annex IX (Chapters I+III) cover a full quality management system assessment, including 

both design and production phases, ensuring MDR/IVDR compliance through the device lifecycle. 

202 QMS certificates under Annex XI (Part A) verify that a manufacturer’s quality management system meets the MDR 

requirements for production quality assurance and ongoing relevant compliance checks. 

203 Product certificates under Annex IX (Chapter II) are issued following an assessment of the technical documentation 

for a device to verify their conformity with MDR/IVDR requirements. 

204 Product certificates under Annex X are issued after a type-examination procedure confirming that a representative 
device  sample,  it’s  technical  documentation  and  the  relevant  life-cycle  processes  meet  the  relevant  safety  and 
performance requirements under the MDR/IVDR. 

35 

 
 
 
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  concern205.  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  inputs206,  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 duplication207 particularly affecting SMEs. Whilst no harmonised cost figures 
exist, consultation findings208 suggest the administrative time for this equals several FTE 

205 Call for evidence – 112 out of 275 respondents:  50 from Company/Business, 20 from Health Providers, 15 from 
Business  Associations,  10  from  EU  Citizens,  7  from  NGOs,  5  from  non-EU  Citizens,  3  from  Others,  2  from 
Academic/Research Institutions. 

206 Economic operator survey, Call for Evidence, the Public Consultation.  
207 Economic operator survey and Call for Evidence. 
208 Reality check workshop with manufacturers. 

36 

 
 
 
days annually. Another source of administrative burden lies in the many and sometimes 
overlapping reporting obligations209 (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 framework210. 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 predictability211. 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,  stakeholders212  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  recognised213  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. 

4.1.2.2. Importers/distributors: Costs   

Despite  consultation  efforts,  only  limited  data  is  available  on  costs  for  importers  and 
distributors214, 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. 

4.1.2.3. 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 

209  These  include  the  CEP,  CER,  PMCF  Plan,  PMCF  Evaluation  Report,  PMS  Plan,  PMS  Report,  PSUR  and  PSR, 

SS(C)P, and Trend Reports. See sections 4.1.1.2 and 4.1.1.4 for acronym explanation.   

210 Call for Evidence. 
211 Position papers. 
212 Call for Evidence. 
213 Position papers. 
214 Economic operator survey. 

37 

 
 
 
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).  

4.1.2.4. 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, 

38 

 
each requiring staff time ranging from 37 to 156 hours per application215; 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. 

4.1.2.5. 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 areas216. From one evidence source, a price increase for some medical devices 
was also reported by health professionals217. 

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. 

4.1.2.6. 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). 

215 Targeted national competent authority survey. 
216 Call for Evidence. 
217 Reality check workshop with healthcare professionals, users and patients. 

39 

 
 
 
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. 

4.1.2.7. 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 

218 Call for Evidence.  

40 

 
 
 
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  another221.  Whilst  there  is  little 
evidence  from  other  consultation  activities222  on  major  issues  or  specific  examples  of 
incoherent provisions, common recurring inconsistencies mentioned  were regarding  the 
use of terminology and contradictory requirements223. 

On coherence between the Regulations, approximately 80-85% of provisions are the 
same or similar224. Whilst this may suggest a high level of consistency, inconsistencies 
remain. This is especially where IVDR provisions are too extensively modelled on MDR 

219 European Commission website, EU4Health annual work programmes 2023 and 2024.  
220 ‘EMA targeted survey’, conducted in the context of the Targeted Evaluation of the MDR/IVDR.   
221 Public consultation. 
222 e.g. in the Call for Evidence and position papers.  
223 Call for Evidence – 87 out of 105 responses: 30 from Company/Business, 15 from Business Associations, 14 from 
Health Providers, 10 from EU Citizens, 8 from Other, 6 from Academic/Research Institutions, 2 from NGOs, 2 from 
Public Authorities. 

224 Input by external expert, see Annex I. 

41 

 
 
 
 
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 include225: 

•  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 
like  routine  blood  draws. 
scrutiny  for 
Consequently,  these  studies  face  stringent  requirements  akin  to  high-risk  medical 
device procedures, creating unnecessary burdens without added value for patients. 

low-risk  IVD  performance  studies, 

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 confounded226. 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 

225 Input by external expert, see Annex I. 
226 "Significant change" affects a legacy device's market status under the transitional regime, while "substantial change” 

generally requires notified body review of a device or manufacturer’s QMS before implementation. 

42 

 
 
 
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 
compared227 (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 frameworks228 (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 Directive229) or applicability of complimentary regulations (e.g. the Machinery 
Regulation230), this is not true in all cases. Examples for improved alignment commonly 
called for across stakeholder groups were to the Artificial Intelligence Act231 (AI Act), the 
Clinical Trials Regulation232 (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 below233:  

•  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).  

227 Public Consultation. 
228 Call for Evidence, Position Papers. 
229 Regulation (EU) 2017/745, OJ L 117, 5.5.2017, pp. 1–175, ELI: http://data.europa.eu/eli/reg/2017/745/oj. 
230 Regulation (EU) 2023/1230, OJ L 165, 29.6.2023, pp. 1–102, ELI: http://data.europa.eu/eli/reg/2023/1230/oj. 
231 Regulation (EU) 2024/1689, OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj.   
232 Regulation (EU) No 536/2014, OJ L 158, 27.5.2014, pp. 1–76, ELI: http://data.europa.eu/eli/reg/2014/536/oj. 
233 Analysis supported by input from external expert see Annex I. 

43 

 
 
 
•  The  Network  and  Information  Systems  II  Directive234  (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)  Regulation236 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 IVDs238. 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  Regulation239  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 

234 Directive (EU) 2022/2555, OJ L 333, 27.12.2022, ELI: http://data.europa.eu/eli/dir/2022/2555/oj. 
235 Regulation (EU) 2022/123, OJ L 20, 31.1.2022, pp. 1–37, ELI: http://data.europa.eu/eli/reg/2022/123/oj.  
236 Regulation (EU) 2025/327, OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj.  
237 Regulation (EU) 2021/2282, OJ L 458, 22.12.2021, pp. 1–32, ELI: http://data.europa.eu/eli/reg/2021/2282/oj. 
238  See  Article  7 

(c)  of  Regulation 

(EU)  2021/2282,  OJ  L  458,  22.12.2021,  pp.  1–3, 

(1)  point 
ELI: http://data.europa.eu/eli/reg/2021/2282/oj.  

239 Regulation (EU) 2023/1542, OJ L 191, 28.7.2023, pp. 1–117, ELI: http://data.europa.eu/eli/reg/2023/1542/oj. 
240 Regulation (EU) 2025/40, OJ L, 2025/40, 22.1.2025, ELI: http://data.europa.eu/eli/reg/2024/1781/oj.  

44 

 
 
 
 
 
 
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 approach241. In addition, the Regulations are 
included  in  and  align  with  the  European  Health  Union  Strategy242,  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 EMA243. 

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 
Strategy244, the Commission announced in August 2025, a simplification revision of the 
MDR and IVDR245. This should improve the coherence of the Regulations to wider policy 
priorities of the Draghi report on EU competitiveness246, the “Competitiveness Compass”247 
and  the  Simpler  and  faster  EU  communication  Simplification  and  Implementation248, 
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 strategy249) 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 

241 European Commission website, One Health. 
242 The European Health Union: Protecting our health together, COM/2024/206 final. 
243 Regulation (EU) 2022/123, OJ L 20, 31.1.2022, pp. 1–37, ELI: http://data.europa.eu/eli/reg/2022/123/oj. 
244 European Commission, Commission launches new strategy to make Europe a global leader in life sciences by 2030, 

Press release, 2 July 2025 https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686. 

245 European Commission Have Your Say webpage, Medical devices and in vitro diagnostics – targeted revision of EU 
rule:  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Targeted-revision-of-the-EU-
rules-for-medical-devices-and-in-vitro-diagnostics-_en.  

246 Draghi, M., The future of European competitiveness, September 2024. 
247 A Competitiveness Compass for the EU, COM/2025/30 final.  
248 A simpler and faster Europe: Communication on implementation and simplification, COM/2025/47 final. 
249 The EU Startup and Scaleup Strategy Choose Europe to start and scale, COM/2025/270 final. 

45 

 
 
 
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 IVDs250. Stakeholders also recognise the cost benefits in complying with one 
EU  Regulation  over  different  rules  at  the  national  level251,  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 

250 Public consultation, all stakeholder categories (except citizens) who strongly agree or agree: 93,3% (224/240) for MD 

– 64,6% (73/113) for IVD. 

251 Public consultation, stakeholder responses (except citizens): 49% or 117/240 and 50% or 119/240 respectively for the 

MDR; 58% or 65/113 and 56% or 63/113 respectively for the IVDR. 

46 

 
 
 
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 safety252 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 costs253. 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. 

252 Position papers. 
253 Public Consultation stakeholder responses (except citizens): 109/240 on the MDR; 48/113 on the IVDR. 

47 

 
 
 
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 framework255. 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  years256.  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 feedback259. Stakeholders overall supported greater transparency 
through  EUDAMED,  UDI,  and  public  access  to  clinical  data260.  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. 

254  Biomedical  Alliance  in  Europe  (BioMed  Alliance),  European  Patients  Forum  (EPF),  European  Association  of 
Hospital  Pharmacists  (EAHP),  European  Hospital  and  Healthcare  Federation  (HOPE),  Open  letter:  Meeting  the 
needs of patients, healthcare practitioners and hospitals in the targeted revision of the Medical Devices Regulation, 
11 September 2025.  

255 Reality check workshop with healthcare professionals, users and patients. 
256 Study on governance. 
257  Citizens  responses  to  the  PC:  varying  by  device  group,  66,67%  -75%  largely  agreed/agreed  there  was  access  to 
information  on  devices  and  device  usage;  40%  -  62,5%  largely  agreed/agreed  that  device  risk  information  was 
sufficient.  

258 Reality check workshop with healthcare professionals, users and patients. 
259  Call  for  evidence  –  34  out  of  121  respondents:  10  Business,  8  Health  Providers,  6  Business  Associations,  4  EU 

Citizens, 3 NGOs, 2 Academics, 1 Public Authority. 

260 Position paper. 

48 

 
 
 
 
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 manufacturers262.  

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 Evidence265.  

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 
innovation266,  which  may  hamper  innovative  devices  reaching  the  EU  market267,268. 
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 
technologies269. 

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 

261  Call  for  evidence  –  65  out  of  330  respondents:  30  from  Company/Business,  15  from  Health  Providers, 10  from 

Business Associations, 5 from EU Citizens, 3 from Academic/Research Institutions, 2 from Other. 

262 See note 111, page 21.  
263 Position paper, Call for Evidence. 
264 Public consultation. 
265 Call for evidence – 48 out of 330 respondents: 48 feedback to the Call for Evidence discussed misalignment of the 
Regulations with emerging technologies and needs: 25 from Company/Business, 10 from Health Providers, 5 from 
Academic/Research Institutions, 4 from NGOs, 3 from Other, 1 from EU Citizens. 

266  See note 265, pg 49. 
267  60%  of  stakeholders  in  a  study’s  survey  disagreed  that  the  regulatory  framework  fosters  innovation  (Diana 
Vertelkiene, Yves Verboven, Liz Rezaglia, Ana Duc, MILESTONE MS16- Second Annual MD/IVD Industry pulse 
report, Project: 101101269 – NoBoCap - EU4H-2022-P), 2025. 

268 See note 111, page 21.  
269 Call for evidence – 47 out of 253 respondents: 20 from Company/Business, 10 from Health Providers, 7 from Business 

Associations, 5 from Academic/Research Institutions, 3 from NGOs, 2 from EU Citizens. 

49 

 
 
 
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. 

WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? 

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 

50 

 
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 

51 

 
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. 

52 

 
 
 
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. 

53 

 
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. 

54 

 
 
 
 
 
 
 
 
 
 
 
 
ANNEX I:   PROCEDURAL INFORMATION 

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. 

55 

 
 
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”). 

56 

 
 
 
 
ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED 

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 

57 

 
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 

58 

 
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 

59 

 
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. 

60 

 
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. 

Score Interpretation 

Typical evidence pattern 

++ 

Strong positive impact 

Consistent  quantitative 
consensus 

improvement  and  strong  qualitative 

+ 

0 

- 

-- 

Some positive impact  Majority of evidence positive, some reservations 

Neutral or mixed 

Evidence divided or inconclusive 

Some negative impact  Majority of evidence negative, but not overwhelming 

Strong negative impact Convergent evidence of substantial adverse impact 

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. 

61 

 
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 

fees 

for  certification,  preparation  of 

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

o 

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. 

62 

 
 
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 

63 

 
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 

64 

 
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. 

65 

 
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. 

66 

 
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. 

67 

 
 
 
 
ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS ON ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) 

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.  

in 

Evaluation question 
Effectiveness 
(1)  How  successful  have 
the  MDR  and  IVDR 
been  in  contributing 
general 
to 
its 
terms 
objectives 
of: 
(a) ensuring  a  high 
level  of  protection 
for 
health 
of 
patients and users?  
(b) ensuring  a  smooth 
functioning  of  the 
internal market as 
regards  medical 
devices?  
(c) supporting 

competitiveness 
and  innovation  in 
the  sector,  taking 
account 
into 

Judgment criteria 

Indicator  

Data source  

Type of assessment 

-MDs  and  IVDs  placed  on 
the  market  are  safe  and 
performant. 
-Availability  of  safe  devices 
is 
the  Union  market 
on 
maintained  or 
improving 
across key categories. 
-Devices 
specific 
target 
needs  of  patients  and  target 
patient groups.  
-Improved 
of 
health of patients and users.  
-Even  playing  field  across 
the EU for businesses 
of 
level 
-Increased 
innovation/ competitiveness. 
for  placing 
-EU  market 
research 
or 
innovations 
purposes. 

protection 

quantitative  and  qualitative 
assessment 

in 

Legal certainty 
-Number of legal disputes 
-Experience/perception 
implementation. 
-Number of disputes between 
manufacturers  and  notified 
bodies 
device 
on 
classification 
-Average duration of Helsinki 
procedure (MD/IVD) 

Legal certainty 
-NCA survey 
- MDCG guidance documents 
(EC  website),  Study  on 
CFE, 
governance, 
position papers, Reality check 
workshop 
with 
manufacturers,  EC  internal 
sources  

PC, 

Transparency 
- EUDAMED  
- PC, CFE, position papers 

quantitative  and  qualitative 
assessment 

Transparency 
-Extent  of  public  availability 
information  via 
of  device 
traceability 
mechanisms, 
EUDAMED and reports such 
as  Publication of documents: 
SSCPs,  summary  monitoring 
reports);  

68 

 
 
 
 
 
 
 
 
 
 
specificities 
SMEs? 

of 

(d) ensuring  a  high 
of 
level 
transparency 
on 
medical devices for 
all 
and 
actors 
citizens?   

level 

-Increased 
of 
transparency  of  information 
on devices.  
-Traceability  and  lifecycle 
monitoring  of  devices  are 
ensured across the EU. 

-stakeholder  experience  and 
satisfaction  with  access  to 
device information.  

Trust 
-Stakeholders’ 
regulatory system 

trust 

in 

Trust 
PC, CFE, position papers 

qualitative assessment 

quantitative  and  qualitative 
assessment 

Notified bodies (NBs) 
-NANDO information system 
website),  MDCG 
(EC 
guidance  documents 
(EC 
website) 

-  Data from NB designation 
process, (EC internal 
sources), NCA survey 

Notified bodies (NBs) 
-Number  of  NBs  designated, 
code coverage in designation 
scope. 
-Average 
designation 

for  NB 

time 

-Number  of  meetings  and 
MDCG  guidance  documents 
on  NBs 
and 
coordination 

oversight 

69 

 
 
 
 
 
issuance 

Conformity assessments 
-Resources  of  NBs  and-time 
for 
new 
certificates 
-Stakeholders’ perceptions of 
and 
predictability 
proportionality of procedures. 

of 

Conformity assessments 
- NB survey, GOG study 

quantitative  and  qualitative 
assessment 

- PC, CFE, position papers 

70 

 
 
quantitative  and  qualitative 
assessment 

clinical 

Clinical evidence 
of 
-  Number 
investigation applications 
-Experience of NBs on CERs 
and PERs  
-Number  of  CECP/PECP 
submissions and expert panel 
opinions 
-Stakeholder perceptions  

Clinical evidence 
-  NCA  survey,  EO  survey, 
NB  survey,  Workshop  with 
MDCG  stakeholders,  Reality 
check 
with 
workshop 
manufacturers 
- PC, CFE, position papers 

71 

 
 
 
and 

Competitiveness 
innovation 
-Value and growth rate of the 
European  medical  devices 
market 
-Number  and  growth  rate  of 
patents from the EU 
-EU export position 
the  CE 
-Recognition  of 
marking in other jurisdictions 
-EU’s 
international 
cooperation 
-Number 
operational agreements 
-Number 
issued 
audits 
MDR/IVDR) 
-Stakeholders’ perceptions of 
Union  market  attractiveness 
for innovation. 

certificates 
combined 
& 

of 
through 

(MDSAP 

bi-lateral 

of 

and 

Competitiveness 
innovation 
-MedTech  Europe  facts  & 
figures 2025 
- European Patents Office 

-PC 

-IMDRF website,  

EC internal sources 

-NB survey 

-PC,  CfE,  position  papers, 
study on governance 

in 

-Experience 
uniform 
application  of  requirements 
and national practices 
-Number  of  applications  and 
issued certificates 

-PC, CfE, position papers 

-GOG study 

72 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
-EC internal sources 

-PC,  CfE,  position  papers, 
reality  check  with  healthcare 
professionals, users, patients 

-Number  of  notification  of 
or 
interruptions 
discontinuations of devices  
-Stakeholders’  perception  on 
shortages  and  on 
related 
including 
patient 
orphan devices 
-Experience  of  stakeholders 
on requirements  for in-house 
devices 

needs, 

73 

 
 
 
 
 
(Post-)Market  surveillance 
and vigilance 
-Stakeholders perception 

(Post-)Market  surveillance 
and vigilance 
-reality check with healthcare 
professionals, users, patients 

-PC,  EC 
NCA survey 

internal  sources, 

-PC, CFE, position papers 

-EC  internal  sources,  NCA 
survey  

-Trend  in  number  of  serious 
incident 
(MIR), 
reports, 
periodic safety reports (PSR), 
field safety corrective action. 
-Stakeholders’ 
perceptions 
perception  of  effectiveness 
of 
proportionality 
and 
PMS/vigilance requirements 

-Number  of  proactive  and 
reactive  on-site 
inspection 
and products controls  
-Participation of NCAs in EU 
coordination on vigilance and 
market 
(e.g. 
surveillance 
coordination  exchanges,  task 
forces or obligations etc). 

74 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Simplification 
experience 
-Stakeholders’ 
and views on the governance 

Simplification 
- CFE, position papers, study 
on governance 

-Stakeholders’  perception  of 
predictability, 
proportionality, 
administrative burden. 
-  Experience  with  use  of 
digital tools and EUDAMED  

and 

- PC, CFE, position papers, 
study on governance, Reality 
check workshop with 
manufacturers  

75 

 
 
 
 
 
 
 
 
 
(2)  What 

internal  and 
external factors have 
contributed 
to  or 
hindered the progress 
towards 
the 
the 
objectives 
MDR and IVDR? And 
how?  

of 

-Impact of COVID-19 
-Effectiveness  &  efficiency 
of governance structure 

- EC internal sources, MDCG 
on 
guidance 
COVID-19 (EC website) 
- Study on governance  

documents 

quantitative  and  qualitative 
assessment 

/ 

qualitative assessment 

(3)  (a)  To  what  extent 
have  the  objectives 
been achieved and to 
what  extent  can  they 
still be achieved? 
(b)  Considering  the 
regulatory 
current 
framework  and  ways 
of 
it, 
implementing 
can they be achieved 
by  the  end  of  the 
transition period?  

/ 

-Objectives  are  considered 
evidence 
achieved  when 
clear 
shows 
progress 
improved  safety, 
towards 
transparency, 
legal 
certainty,  and  a  functioning 
internal market. 

-The stage of implementation 
of the Regulation shows that 
the  objectives  related 
to 
patient  safety,  transparency 
traceability  can  be 
and 
achieved  by  the  end  of  the 
transition period. 

(4)  To  what  extent  are 
the extensions of the 
transition 
periods 
and other introduced 

-Sufficient transition periods 
for  all 
to 
implement the Regulations in 
time.  

stakeholders 

Stakeholder’s experience 
with transition periods 

- position papers 

qualitative assessment 

76 

 
 
 
 
 
-Problems 
identified  have 
been  addressed  and  ensure 
that  the  objectives  of  the 
Regulations can be met. 

limited 

number 

-A 
of 
unexpected  or  unintended 
have 
negative 
occurred. 

effects 

Availability of devices  

- GOG survey, PC, CFE, 
position papers  

quantitative  and  qualitative 
assessment 

Competitiveness/innovation  

- EO survey, GOG survey, 
PC, CFE, position papers  

changes 
legislative 
the 
addressing 
concerns identified at 
the early stages of the 
implementation of the 
MDR/IVDR?   

(5)  Have any unexpected 
or unintended effects 
occurred?  To  what 
they 
extent 
have 
contributed 
or 
progress 
hindered 
towards 
the 
objectives? What can 
explain these effects? 

Efficiency 
(6)  (a)  What 

is 

the 
division  of  costs  and 
benefits  for  different 
stakeholders?  
they 
Are 
(b) 
distributed 
as 
expected  and  if  not, 
why? 

quantitative  and  qualitative 
assessment 

- NB survey, EO survey, 
reality check with 
manufacturers, CfE, PC 

See Annex IV 

Manufacturers: average 
certification costs; cost of 
pre-market clinical 
evaluations/performance 
studies; post-market 
surveillance costs. 

-Costs  and  benefits  are 
proportionate  to  the  roles 
and  responsibilities  of  each 
stakeholder 
group 
(manufacturers, NBs, NCAs, 
health 
institutions, 
Commission). 
-  Benefits  are  materialising 
as intended for  patients  and 
healthcare  systems,  while 
costs  remain  proportionate 
to  stakeholders’  roles  and 
obligations 

77 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
in  a 
regulatory 
face 

-Industry  operate 
clearer 
framework 
increased costs. 
. 

but 

NBs: 
and 
designation 
maintenance  costs;  resources 
for audits and assessments. 

NCAs:  staff  and  IT  costs; 
level 
participation 
vigilance  and  coordination 
activities. 

in  EU 

/ 

EU 
Commission 
EUDAMED 
governance: 
and 
development 
maintenance  costs;  MDCG 
coordination workload; EMA 

- NB survey, EO survey 

- NCA survey 

-EC website, EU4Health 
Programmes, EMA survey 

/  health  systems: 
Patients 
stakeholder  perceptions  of 
device  safety,  quality,  and 
availability. 

- PC, CFE, position papers, 
Reality check workshop with 
healthcare professionals, 
users and patients 

(7)  Are  the  costs  of  the 
MDR/IVDR  justified, 
given the results that 
are being achieved?  

costs 

are 
-Overall 
reasonable in relation to the 
benefits achieved in terms of 
patient  safety,  quality,  and 
public health protection 
-Efficiency  gains  and  long-
(e.g. 
term 
benefits 
trust, 
harmonisation, 

Trends  in  serious  incidents 
and  vigilance  reports  (proxy 
for safety gains). 

Stakeholder  perception  of 
proportionality between costs 
and benefits. 

- PC, EC internal sources, 
NCA survey 

quantitative  and  qualitative 
assessment 

- PC, CFE, position papers 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
transparency) 
short-term 
costs. 

outweigh 
implementation 

Market  growth  or  stability 
despite  higher  compliance 
costs. 

- MedTech Europe facts & 
figures  

-The  Regulations  can  be 
simplified. 

Level  of  harmonisation  and 
achieved 
predictability 
(number  of  NBs  designated, 
guidance issued). 

- NANDO information 
system, EC website, PC, 
CFE, position papers  

Stakeholder  perception  of 
administrative  burden  and 
duplication of reporting. 

Experience with digitalisation 
and EUDAMED use. 

Number  of  overlapping  or 
redundant 
requirements 
identified. 

- PC, CFE, position papers 

- PC, CFE, position papers 

- Expert study on coherence, 
EC internal sources 

-Today’s  needs 
for  safe, 
performant  and  innovative 
medical  devices  in  the  EU 
are addressed. 

Alignment of objectives with 
stakeholders’ current needs. 

- CFE, position papers, 
Reality check workshop with 
healthcare professionals, 
users and patients 

qualitative assessment 

79 

(8)  Is there a potential to 
the 
costs 
the 

reduce 
compliance 
and/or 
administrative 
burden 
compromising 
objectives 
of 
MDR and IDVR? 

without 
the 
the 

Relevance 
(9)  (a)  How  well  do  the 
the 
objectives 
MDR  and  IVDR  still 
correspond 
the 
needs within the EU?   

to 

of 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(b) How effectively 
do the MDR and 
IVDR address 
emerging health 
challenges and 
evolving patient 
needs within the EU? 
(c) How flexible are 
the MDR and IVDR 
to adapt to the 
technological or 
scientific progress 
and innovation in the 
sector that already 
occurred? 

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

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

-Emerging health challenges 
and  evolving  patient  needs 
are addressed. 
-The  Regulations  provide  a 
flexible  framework  allowing 
of 
regulation 
the 
scientific 
technological/ 
progress  and 
innovative 
devices to reach the market. 

framework 
to 

remains 
The 
to 
suitable 
emerging  health  challenges 
and new patient needs. 

respond 

NBs, 

Core processes (designation 
of 
conformity 
assessment,  PMS, vigilance) 
remain 
to 
achieve the objectives of the 
Regulations. 

appropriate 

Stakeholder  perception  of 
of 
relevance 
continued 
MDR/IVDR objectives. 

Stakeholder  perception  of 
to  accommodate 
capacity 
evolving  clinical  and  patient 
needs. 

Stakeholder  perception  of 
regulatory  adaptability  and 
predictability for innovation. 

- Study on governance, PC, 
CFE, position papers  

- CFE, position papers  

- Study on governance, PC, 
CFE, position papers 

Stakeholder 
feedback  on 
continued  suitability  of  key 
processes. 

- PC, CFE, position papers  

The  elements  of  the  MDR 
and IVDR are coherent. 

-Evidence 
alignment 
of 
between  provisions  of  MDR 
and 
the 
IVDR,  within 
Regulations and MDR/IVDR 
requirements 
their 
accompanying Annexes  

and 

80 

- EC internal sources, Expert 
study on coherence, PC, 
CFE, position papers  

qualitative assessment 

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

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

and 

(14) To  what  extent  are 
the  MDR  and  IVDR 
coherent 
with 
international 
obligations 
policies?   
EU added value 
(15) To  what  extent  were 
the  objectives  of  the 
policy 
better 
achieved by reason of 
scale or effects of that 
action  than  by  the 

The  MDR  and  IVDR  are 
overall  coherent  with  other 
EU interventions. 

-Stakeholder perception of 
internal coherence  
-Evidence  and  stakeholder 
perception 
alignment 
of 
between  MDR/IVDR  and 
other Union Regulations (e.g. 
AI 
EHDS, 
packaging/packaging  waste 
etc. 

Act, 

- EC internal sources, Expert 
study on coherence, PC, 
CFE, position papers 

The  MDR  and  IVDR  are 
coherent  with  wider  EU 
policies and priorities. 

-Evidence  of  alignment  of 
MDR/IVDR  with  wider  EU 
policies  

-EC internal sources 

The  MDR  and  IVDR  are 
with 
overall 
international 
obligations 
and policies. 

coherent 

-Evidence  of  alignment  of 
with 
MDR/IVDR 
international  obligations  and 
policies  

-EC internal sources 

-Benefits  resulting  from  the 
to 
Regulations  compared 
what  would  have  been 
expected with Member States 
acting alone. 

in 

requirements 

divergent 
or 

-Reduction 
national 
guidance. 
-Stakeholder  perception  of 
predictability  and  uniformity 
of rules. 

81 

qualitative assessment 

- PC, CFE, position papers  

 
 
 
 
 
 
 
 
 
 
Member States acting 
alone?   

(MDCG, 

-Functioning  of  EU-level 
joint 
structures 
assessments, 
vigilance 
coordination). 
Number of common guidance 
documents and joint actions. 
-Stakeholder  perception  of 
added  value  of  EU-level 
to 
oversight 
national-only regulation. 

compared 

- Study on governance 

- EC website  

- PC, CFE, position papers 

82 

 
 
 
 
 
 
 
  ANNEX IV. OVERVIEW OF BENEFITS AND COSTS, TABLE ON SIMPLIFICATION AND BURDEN REDUCTION 

83 

 
Costs: 

Direct compliance costs 
(adjustment costs, administrative 
costs, regulatory charges) 

Type: 
Choose 
one-off or 
recurrent 

Table 1. Overview of costs and benefits identified in the evaluation 

Citizens/Consumers  

Businesses 

Administrations 

Notified Bodies  

Quantitative   Comment 

Quantitative  

Comment  Quantitativ

Comment   Quantitative  Comment 

[Cost or Benefit description]: 

e 

Costs for 
designation 
process, staffing, 
training, IT, and 
coordination. 

MDR (one-off and 
recurrent): 
-Clinical 
evaluation €30 000 
– €250 000 per 
study. Recurrent 
for each new 
device or major 
change. 
-Certification fees: 
QMS Annex IX 
(I+III) €641 878 
→ €882 988;  
QMS Annex XI 
(Part A) €100 000 
→ €188 524;  
Product Annex IX 
(II) €616 981 → 
€385 617; 
maintenance €48 
503 – €73 244. 
Recurrent for 
renewals and 
annual 
maintenance. 
-Importers €32 
860 / year;  
Distributors €33 
496 / year (after 
outlier exclusion). 

No costs could be 
captured on clinical 
investigations and 
performance 
studies, which tend 
to exceed costs for 
clinical 
evaluations. 

Data collected 
across different 
sources did not 
allow to accurately 
determine cost 
variation across 
certificates for 
different device 
risk classes nor per 
manufacturer size. 

Costs such as NB 
fees and resources 
for clinical 
evaluation or 
performance 
studies can be 
estimated, but 
coverage is 
uneven.  

84 

NCA: NB 
designation via 
joint assessments 
and oversight of 
NBs; Pre-market 
assessment, 37-
156 hours per 
clinical 
evaluation/perfor
mance study; IT 
investments; 
staff recruitment 
and training 
activities, 
including for 
vigilance & 
market 
surveillance; EU 
coordination 
activities (One-
off setup and 
recurrent 
operating costs).  
Perception: 
NCAs report 
increased 
administrative 
burden but 
acknowledge 
improved 

 
                        
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
coordination and 
data quality. 

EU level: 
EUDAMED 
development and 
maintenance 
(one-off and 
recurrent); 
MDCG 
coordination and 
expert panel 
support 
(Commission 
budget lines).  
Perception: 
High initial IT 
investment but 
broad agreement 
on long-term 
value for 
harmonisation 
and 
transparency. 

Less data received 
across IVDR 
certificate types, 
meaning more 
limited analysis 
possible.  

Mostly recurrent 
administrative 
costs. 

IVDR (one-off 
and recurrent): 
-Performance 
evaluation €23 000 
– €70 000 per 
study. 
-QMS Annex IX 
(I+III): issuance 
€1 205 458 (inc. 
€5.5 m multi-
device outlier); 
excluding outlier 
€131 823; “last” 
€388 918; 
maintenance €121 
250. 
-Product Annex IX 
(II): issuance €89 
750 → last €109 
700; change-
management €13 
563. 

Perception: 
Strong consensus 
among Economic 
operators and 
SMEs that costs 
are high and 
disproportionate to 
firm size; Notified 
bodies bottlenecks 
and delays seen as 
major indirect 
drivers of cost but 
problem is 
decreasing.  
Benefits expected 
in legal certainty 

85 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and market trust 
once system 
stabilises. 

Delayed access to 
some innovative 
or niche devices; 
reported shortages 
(recurrent)  
Perception: 
Patients and 
professionals 
acknowledge 
safety benefits but 

-MDR: 
Certification 
timelines 6 – 18 
months (often up to 
24 months); 
Portfolio 
reductions for low-
volume devices; 
SME opportunity 

86 

-Enforcement 
activities 
resulting from 
the monitoring 
of notified 
bodies, vigilance 
(assessment of 
report and 
follow-up) and 
market 
surveillance 
activities (e.g. 
inspections, 
evaluations and 
measures).  
Perception: For 
monitoring of 
notified bodies, 
seen as 
necessary for 
quality control 
but resource-
intensive for 
smaller 
authorities. 

-Transition 
management 
from Directives 
to Regulations 
and associated 
legislative 
amendments; 
coordination 
burden across 
MS and EU 

-Staff training and 
audit costs. (One-
off for 
designation; 
recurrent for 
oversight).  
-Workload linked 
to ongoing 
applications and 
(recurrent) 
surveillance of 
manufacturers 
post-certification 
Perception: 
Variation in NB 
capacity, 
constraints at start 
of implementation 
now easing.  

NB hassle 
costs/waiting 
times for 
designation ((~1 
500 days per 
designation) ; 
quality of 
manufacturer 
applications can 
impact 

Enforcement costs: (costs 
associated with activities linked to 
the implementation of an initiative 
such as monitoring, inspections and 
adjudication/litigation) 

Indirect costs (indirect 
compliance costs or other indirect 
costs such as transaction costs) 

 
 
 
 
 
 
 
 
 
 
 
structures 
(recurrent) 
Perception: 
Short-term 
inefficiency 
accepted as 
transitional. 

certification 
timelines. 
Perception: 
Improving as 
processes stabilise. 

criticise reduced 
availability and 
delays 

costs (one off and 
recurrent) 

-IVDR:  
Higher relative 
burden for in house 
devices and SMEs;  
High compliance 
burden for 
laboratories and 
health institutions, 
with many 
reporting risk of 
discontinuing in-
house devices 
under current 
IVDR 
requirements (one 
off and recurrent) 
Perception: 
Stakeholders see 
indirect effects as 
the most pressing 
issue for 
availability and 
innovation 

- Delayed market 
access, portfolio 
withdrawals, and 
administrative 
burdens—are 
harder to quantify 
but consistently 
reported as 
substantial, 
especially for 
SMEs, niche 
manufacturers, and 
small laboratories. 

Benefits: 

87 

 
 
 
 
 
 
 
 
 
 
 
 
Direct benefits (such as 
improved well being: changes  in 
pollution levels, safety, health, 
employment; market efficiency) 

Indirect benefits (such as 
wider economic benefits, 
macroeconomic benefits, social 
impacts, environmental impacts)  

.  

Higher revenues 
and efficiency 
gains. This 
illustrates a core 
trade-off: costs 
borne by 
manufacturers 
translate into 
revenue for NBs.  

-Improving safety 
and device quality 
through stricter 
clinical/ 
performance 
evidence and post-
market 
surveillance 
(recurrent) 

-Increasing 
transparency and 
traceability via 
UDI and 
EUDAMED 
(modules 
progressively 
operational) 
(recurrent).  
Perception: 
Expected safety 
gains among 
patients and users; 
offset by concerns 
about device 
availability. 

-Higher public 
trust and informed 
choice expected 
through better 
access to device 
information 
(recurrent) 

EU level 
EU-wide 
improved 
oversight and 
knowledge-
sharing through 
MDCG and 
scientific 
oversight of 
devices 
strengthened. via 
expert panels 
(recurrent) 
Perception: 
Positive impact 
on consistency 
and global 
standing of EU 
system. 

-Harmonised rules 
and predictable EU 
framework 
expected to reduce 
legal uncertainty; 
increased safety 
rules enhance CE 
mark credibility 
and reputation 
benefits for 
exporters. 
(recurrent) 
Perception: 
Businesses 
acknowledge long-
term benefits but 
say they are yet to 
materialise due to 
implementation 
delays. 

-Enhanced 
market 
surveillance 
and 
coordinated 
vigilance (8× 
increase in 
product 
controls; +25 
% compliance 
exchanges). 
Perception: 
Authorities 
better 
equipped for 
monitoring 
with 
empowerment 
& common 
EU platforms 
and tools for 
safety and 
traceability 
gains. 

-Long-term 
competitiveness 
and export 
potential from 
global trust and 
recognition of CE 
mark; incentive for 
quality innovation 
once predictability 
improves. 
(recurrent) 
Perception: Most 
industry actors 
agree benefits will 

Efficiency gains 
from shared IT 
systems 
(EUDAMED) 
and harmonised 
guidance 
documents 
(MDCG). 
(recurrent) 
Perception: 
Viewed as major 
administrative 
simplification in 

88 

 
 
 
 
 
 
 
 
 
 
 
materialise once 
backlogs clear. 

the medium 
term. 

EU level 
Improved 
international 
regulatory 
cooperation and 
convergence 
(mutual 
recognition 
dialogues) 
(recurrent). 
Perception: 
Helps EU get a 
leadership 
position in 
global medical 
device regulation 

89 

 
 
 
TABLE 2:  Simplification and burden reduction (savings already achieved) 

Citizens/Consumers/Workers 

Businesses 

Administrations 

Notified bodies 

Quantitative   Comment 

Quantitative   Comment 

Quantitative  Comment   Quantitati

Comment 

Compliance cost savings 

Type: One-off / recurrent  

N/A 

N/A 

Compliance cost savings 

ve 

N/A 

Reduced costs 
of having to 
comply with 
different 
market entry 
requirements 
and multiple 
national 
databases 
from Member 
States 
(recurrent) 

90 

Reduced 
costs from 
having to 
set-up and 
maintain 
regulatory 
databases 
at national 
level (in 
some MS 
so far), 
due to set-

 
               
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
up of EU-
level 
database 
(Eudamed
) 

PART II: II Potential simplification and burden reduction (savings) 

Citizens/Consumers/Workers 

Businesses 

Administrations 

Notified Bodies 

Quantitative  

Comment 

Quantitative  

Comment 

Quantitativ
e 

Comment   Quantitati

Comment 

ve 

Compliance costs 

Type:  One-off / recurrent  

N/A 

N/A 

Streamlining 
reporting 
obligations and 
overlaps (e.g. 
pre-market 
(SSCP) and 
post-market, 
PSUR, etc). 
(recurrent) 

More tailored 
requirements 
for low and 
medium risk 
(e.g. clinical 
evidence) 
devices and for 

91 

Reduce 
overlappi
ng 
assessme
nts of 
reports 
(e.g. 
vigilance)  

National: 
Streamline
d processes 
for Notified 
Body 
designation  

More 
centralised 
oversight 
of NBs 

Streamline
d and 
clearer 
coordinatio
n at EU-

 
 
 
 
 
 
 
 
 
 
 
level (i.e. 
governance
: MDCG 
and sub-
groups)  

in-house 
devices 
(recurrent) 

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 
(recurrent)  

Reduced fees 
charged by NBs 
to micro and 
small 
enterprises 
(one-off & 
recurrent). 

Flexible 
regulatory 

92 

 
 
 
 
  
pathways for 
innovative and 
niche devices 
(orphan, small 
or vulnerable 
populations) 
(recurrent) 

Increased 
digitalisation of 
regulatory 
compliance 
such as via 
expanded 
electronic 
instructions for 
use (e-IFUs), 
electronic 
labelling, and 
the 
development of 
electronic 
submission 
systems 
(recurrent). 

93 

 
 
 
 
Table 1 Synthesis of the cost-benefit analysis per stakeholder category (See also section 4.1.2 of the Evaluation Report) 

Impact 

Weight / 
Importance 

Score  
(--/–
/0/+/++) 

Explanation (qualitative summary) 

Manufacturers 

Importers / 
Distributors 

Notified Bodies  

NCAs 

H. Health 
Providers 

Patients / Users 

EU-level 
governance 

Costs 

High 

– – 

Substantial compliance costs: clinical /performance evaluations, technical documentation, NB 
fees, post-market surveillance. Strongly disproportionate for SMEs and low-risk devices. 

Benefits 

Medium 

Costs 

Benefits 

Low 

Low 

Costs 

Medium 

+ 

– 

0 

– 

Potential for greater legal certainty, reputational gains, better market access through 
harmonisation. Benefits recognised but not yet fully materialised. 

Mainly administrative: EUDAMED registration, CE verification, documentation flows. Felt 
most heavily by SMEs. 

Benefits are neutral, no direct benefits reported. 

High costs for designation, staff recruitment, training, IT, and coordination. 

Benefits 

Medium 

++ 

Significant increase in revenues from certification activities; specialisation creates efficiency 
gains.  

Costs 

Medium 

Benefits 

Medium 

Costs 

Medium 

Benefits 

Medium 

Costs 

Medium 

Benefits 

High 

Costs 

Medium 

Benefits 

Medium 

– 

+ 

– 

+ 

– 

+ 

– 

+ 

Higher HR needs, IT investment (especially EUDAMED, vigilance), participation in MDCG 
and joint assessments. Particularly heavy for smaller NCAs. 

Stronger market surveillance role, legal clarity, improved coordination across Member States. 

Administrative burden for health institutions for in-house devices, delays in access to 
innovative devices, compliance costs for IVDR. 

Despite the costs, improved safety assurance and clinical evidence requirements, along with 
anticipated gains in transparency through EUDAMED. 

Indirect: reduced availability of niche/innovative devices, delays in access. 

Improving safety, higher device quality, transparency and trust in CE marking. Benefits not 
fully realised due to on-going implementation, potential for increased score.  

Development and maintenance of EUDAMED, staff resources for MDCG coordination and 
joint assessments (EC), and consultation procedure handling (EMA).  

Harmonised Union market, stronger global positioning, reduced duplication of national 
frameworks. 

94 

 
 
 
ANNEX V. STAKEHOLDERS CONSULTATION - SYNOPSIS REPORT  

1.  INTRODUCTION: OBJECTIVES, CONSULTATION ACTIVITIES, METHODOLOGY  

1.1.Objectives of the consultation 

The  Commission  held  various  consultations  for  a  targeted  evaluation  of  the  Regulations.  The  aim  of  this  consultation  was  to  collect  evidence  and 
perspectives of all stakeholder groups on the performance of the legislation, focusing on the impact of the legislation on the availability of devices, including 
devices for small populations (‘orphan’ and ‘niche’), as well as the development of innovative devices, costs and administrative burdens arising from the 
legislation, and benefits of the legislation.  

This synopsis report provides an overview of the consultation activities undertaken, and a description of the results. 

This synopsis report is largely based on the synopsis report prepared by a contractor in the context of the analysis of some evidence collected270. 

1.2.Overview of consultation activities  

The public consultation (PC) (12 December 2024 to 21 March 2025) aimed to obtain feedback on the effectiveness, efficiency, relevance, coherence and 
EU added value of the MDR and IVDR from their implementation in 2017 to 2024. The consultation asked for views on the effectiveness of how the MDR 
and IVDR are implemented, focusing on the protection of health for patients and users, transparency and traceability of medical devices on the Union 
market, the functioning of the internal market for medical devices, the competitiveness and innovation of the medical device sector in the EU, and the 
efficiency,  relevance  and  coherence  of  the  EU  rules  on  medical  devices.  In  this  context,  a  specific  set  of  questions  was  available  for  citizens  and 
organisations representing patients. The rest of the questionnaire was structured around two sections, one applicable to medical devices (MDs) and one 
applicable  to  in  vitro  diagnostic  medical  devices  (IVDs).  The  PC  was  accompanied,  during  the  same  period,  by  a  Call  for  Evidence  (CfE)  allowing 
interested parties to provide feedback.  

270 See note 25, pg 7. 

95 

 
 
 
Information was also collected through targeted surveys conducted for the following groups:  

• 

• 

• 

• 

National competent authorities (December 2024 – March 2025),  

Notified bodies (November 2024 – January 2025),  

Economic operators (EOs) (January 2025 – March 2025) 

European Medicines Agency (EMA) (January 2025 – March 2025),  

In addition, views from healthcare professionals were extracted from a survey conducted by GOG271. 

Furthermore, two reality check workshops have been organised. A workshop with manufacturers on costs was organised in February 2025, and a workshop 
with healthcare professionals, patients and users on costs and benefits was organised in March 2025.  

Consultation activities also took place in the context of the MDCG, including a dedicated workshop in February. An information session on the evaluation 
has been organised by the European Commission with international partners to communicate on the ongoing work (May 2025). 

Additional analysis was conducted on position papers submitted as ad-hoc contributions through the ‘Study supporting the targeted evaluation of the 
MDR and IVDR’. 

Furthermore, in the context of the ‘Study on Regulatory Governance and Innovation in the field of Medical Devices’272, consultation activities including 
one survey (open from 12 December 2023 until 5 February 2024, with a total of 470 responses considered for the analysis), interviews, as well as four 

271 European Commission website – Study supporting the monitoring of availability of medical devices on the EU market. The study has been contracted to a consortium led by the Austrian National Public 

Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting, Survey on the Health Service Providers. 

272 See note 91, pg 18. 

96 

 
 
 
 
thematic workshops and  three additional  stakeholder consultation  workshops. In this  context,  one of the  four thematic workshops  was organised 
specifically with representatives of SMEs (with 28 organisations attending). 

1.3.Stakeholders mapping 

These activities aimed to target all interested parties, including EU institutions and agencies, Member States competent authorities, economic operators 
(both SMEs and large manufacturers), notified bodies, EU Authorised Representatives, healthcare professionals or institutions, importers and distributors 
of medical  devices in  the EU,  regulatory affairs  experts, system/procedure pack producers, international  intergovernmental  organisations, civil  society 
organisations,  clinical  investigators,  ethics  committees,  the  general  public,  patients  and  consumers,  independent  experts  from  academic  and  research 
institutes, and non-EU/EEA countries (see detailed stakeholder mapping in Annex VIII). 

1.4.Methodology 

With regards to the Public Consultation and Call for Evidence, the European Commission has performed the analysis of potential campaigns, duplicates 
and respect of feedback rules. 

In the context of the ‘Study supporting the targeted evaluation of the MDR and IVDR’, the contractor analysed part of the Public consultation questionnaire, 
the Call for Evidence, the surveys on economic operators, national competent authorities and notified bodies, as well as the position papers. For these, two 
main methodologies were applied: one for the surveys (the public consultation, economic operators survey, national competent authorities survey, notified 
body survey), and another for the analyses of the Call for Evidence and of the position papers. While both followed a consistent methodology, adaptations 
were executed to fit the specific type and format of the data.  

Data of the PC and surveys were reviewed, cleaned, and reformatted as needed, with considerations and potential data limitations noted throughout. Survey 
questions were first classified by type, and an appropriate analysis method was assigned to each. All responses were then analysed accordingly per question 
using Microsoft Excel while taking potential limitations into consideration. 

One limitation of the analyses using surveys was a lack of consistency and clarity in the treatment of missing data. In certain instances, respondents who 
were unable or unwilling to provide figures entered a value of 0. This approach created ambiguity, as the entry could be interpreted as representing an 
actual value of zero (e.g., 0 EUR), when in fact it reflected a deliberate decision not to disclose data. In another survey, respondents were instructed to leave 

97 

 
fields blank if the requested information could not be retrieved. It is not possible to determine with certainty whether a blank field indicates the unavailability 
of  data  or  simply  a  skipped  question.  Another  limitation  of  the  data  was  insufficient  response  numbers  to  conduct  comparisons  across  sub-groups  of 
respondents.  

The position papers and the Call for Evidence were also analysed in a similar fashion. Position papers (including a number of literature articles) and Call 
for Evidence inputs (survey text box responses and attached documents) were first reviewed and cleaned (e.g. removing duplicates of position papers or 
Call for Evidence attachments sent by the Commission). The text retrieved from the position papers and Call for Evidence was then processed using the AI 
Policy Concierge (AIPC), a tool developed by Technopolis' Data Science Unit to apply generative AI in policy analysis. The AIPC securely applies a large 
language model and allows for customised prompts; in this case, to extract summaries, authors, affiliations, publication dates, and thematic relevance per 
document including examples (for position papers) or per entry (for Call for Evidence). The extracted text was then analysed by theme and stakeholder 
group. Stakeholder identification differed between Call for Evidence and position papers: the Call for Evidence included stakeholder details submitted as 
part  of  their  Call  for  Evidence  response  (standard  categories  included  in  EU  Survey/Have  Your  Say),  while  the  position  papers  required  stakeholder 
groupings to be extracted from author affiliations. The AIPC analysis was complemented by sample checks to ensure the quality and accuracy of the output 
produced. 

The use of an AI tool in this application comes with both benefits and limitations. Its main advantage lies in its ability to quickly process and analyse large 
volumes of text, which is crucial given the number of responses and documents involved. It also efficiently retrieves key information such as authors, 
affiliations, publication dates, and develops summaries accurately. However, the following limitations are to be considered: 

•  The first limitation is the high sensitivity with linking themes when the AIPC is applied to analyse feedback; a theme that is briefly mentioned but 
not deeply discussed is considered as a linkage to a theme. A sample of 10 to 15 documents was reviewed prior to each iteration/run of the AIPC to 
verify interpretations and assess the output. The reviews showed that while the AIPC made accurate links, it also included indirect and/or weaker 
links to the themes. No links were found to be fully incorrect, but this sensitivity should be kept in mind when interpreting the results. 

98 

 
•  The second limitation is that language models have inherent challenges in counting273, which affects the counting of stakeholder perspectives 
with  the AIPC. The model  may over-  or under-count  by a few responses. To validate the counts, a smaller sample of responses was manually 
reviewed. The findings were consistent in broad terms, though some results may remain open to interpretation— similar to manual (or ‘human’) 
analysis.  

•  The third limitation is that language models do not generate identical output with each run. Because multiple feedback rounds required refining 
and several iterations of the AIPC analysis, there may be small variations between runs. Despite this, the overall results were largely consistent, 
allowing to build on previous versions.  

2.  The other consultation activities (i.e. the remaining surveys, the workshops and the additional Public Consultation questions) were analysed 

separately. RESPONDENTS TO THE CONSULTATION PROCESS 

2.1. General overview 

Table 1 outlines stakeholder groups directly, indirectly, or potentially affected by the MDR and IVDR. A mix of medium/high, medium/medium, low/high 
and low/medium stakeholders have also provided data thereby maximising the breadth of the influences and interests taken into account. The PC and CFE 
are public consultations open to all stakeholders and citizens. Table 1presents the stakeholder groups who have participated Clinical investigators, ethics 
committees, and other international associations  were identified but not consulted).274 

273 Thomas Ball, Shuo Chen and Cormac Herley (2024). Can We Count on LLMs? The Fixed-Effect Fallacy and Claims of GPT-4 Capabilities. Retrieved from: https://arxiv.org/html/2409.07638v2 
274 These groups were not included as selectable options in the user type section of the public consultation or call for evidence there are limitation in identifying these groups. This is because they were 

difficult to reach.  

99 

 
 
 
 
Table 1 Stakeholders consulted275 

Stakeholder group 

Influence 

Interest 

Consultation method 

PC 

CfE 

Surveys 

PP 

MDCG 
meeting
s 

Reality 
check 
workshop
s 

Info 
session 

European Commission and EU bodies, including the EMA 
EU MS competent authorities 
Large European manufacturers and/or associations  
Notified bodies 
EU Authorised Representatives 
Healthcare professionals and institutions, and/or 
associations  
European SMEs and start-ups 
Importers and distributors of medical devices in the EU, 
and/or associations  
Regulatory affairs experts, and/or associations  
System/procedure pack producers (SPPP) and/or 
associations  
International intergovernmental organisations and other 
international associations  
Large non-EU manufacturers 
Civil society organisations (CSOs) 
Clinical investigators 
Digital health, software and AI-tech developers 
Ethics committees 

High 
High  
High  
High 
Medium 
Medium 

Medium 
Medium 

Medium 
Medium 

High 
High 
High  
High 
High  
High  

High 
High  

High 
High  

Medium 

Medium 

Medium 
Low  
Low 
Low 
Low 

Medium 
High  
High 
High  
High 

275 This table does not include activities under the governance study. 

100 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stakeholder group 

Influence 

Interest 

Consultation method 

PC 

CfE 

Surveys 

PP 

MDCG 
meeting
s 

Reality 
check 
workshop
s 

Info 
session 

General public, patients and consumers, and/or associations   Low 

Non-EU SMEs and start ups 

Low 

High  

High 

Independent experts from academic and research institutes  

Low 

Medium 

Non-EU/EEA authorities  

Low  

101 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
More details on some of the consultation activities are provided in the sub-sequent 
sections. 

2.2. Public consultation (PC)  

Detailed information on the public consultation results and the Factual Summary Report 
can  be  found  on  the  Have  Your  Say  webpage276.  No  duplicates  or  campaigns  were 
identified, and feedback rules were respected. All 332 responses as well as 51 attachments 
(out of 52) were included in the analysis.  

86% of responses came  from  16 EU Member States (287/332). The majority of replies 
(42% or 145) were submitted by individuals in Germany and France. In contrast, 14% of 
responses  were  from  respondents  in  non-EU  countries  (United  States  (23);  Switzerland 
(10); United Kingdom (5); Australia (2); China (1); Türkiye (1); Liechtenstein (1); Brazil 
(1); Canada (1)).  

The  number  of  responses  per  stakeholder  type  is  shown  in  Figure  1277.  As  part  of  the 
economic  operators,  a  majority  of  responses  were  from  small  and  medium-sized 
enterprises (43 were medium (50-250 employees); 32 were small (10-50 employees); 17 
were  micro  (less  than  10  employees))  in  comparison  to  59  responses  from  large-sized 
companies (250+ employees). 

The majority of public authorities (n=11) were national authorities (n = 8). In addition, 
two  regional  and  one  local  authority  also  contributed  to  the  PC.  No  duplicates  or 
campaigns were identified, and feedback rules were respected. All 332 responses as well 
as 51 attachments (out of 52) were included in the analysis. 

Note that EU/non-EU citizens responded to a different, more limited, set of questions than 
other stakeholder types. In this synopsis report, unless otherwise specified, findings from 
the PC refer to findings from all stakeholder types except citizens.  

276 European Commission website, public consultation – EU rules on medical devise and in vitro diagnostics – targeted 

evaluation 

277  Note  that  three  Notified  Bodies  who  completed  the  survey  did  not  identify  themselves  as  such  in  the  public 
consultation. As a result, they were classified under “Other”, in line with their own self-identification, rather than 
being included in the Notified Bodies category.  

102 

 
 
 
 
 
 
 
 
 
Figure 1 Survey respondents by stakeholder type 

When reporting PC results, the percentage of respondents who agreed or strongly agreed 
with  each  survey  statement 
the  share  of  people 
selecting agree/strongly  agree is  compared  with  all  other  options  (neutral,  disagree, 
strongly disagree, not applicable/don’t know). 

is  shown.  In  other  words, 

2.3. Call for Evidence 

Detailed information on the Call for Evidence and all received feedback responses can be 
found on the European Commission Website278. A total of 584 feedback responses have 
been received, including both survey text box responses and 186 attached documents. 
During data cleaning: 

•  6 responses were discarded for not complying with feedback rules. 

•  4 duplicates were removed (organisations that submitted feedback twice). 

•  1 campaign consisting of 13 entries was removed and analysed separately. 

•  28  responses  were  merged  into  9  because  they  were  considered  successive  and 

complementary feedback.  

This  resulted  in  a  final  set  of  542  feedback  items,  of  which  168  included  one  or  more 
attachments. In the study, the responses were analysed across 20 themes, defined by the 
European Commission. Where this synopsis report refers to specific figures or percentages, 
these are calculated on the total number of feedback responses discussing a specific theme. 

278 European Commission website, call for evidence – EU rules on medical devices and in vitro diagnostics – targeted 

evaluation   

103 

147 companies/businesses4 business associationsof which5 companies/businesses2 business associationsof which28 companies/businesses25 business associationsof which1517531111595320210Economic operatorNotified bodyCompany/business or businessassociation (neither notified bodynor economic operator)Public authorityAcademic/Research InstitutionHealth providerPatient organizationNGO (Non-governmentalorganisation)EU CitizenNon-EU CitizenOther 
 
 
 
 
For this reason, there are different denominators used throughout the analysis of the Call 
for Evidence. The denominator for a given figure or percentage is always provided.  

The distribution of participating stakeholders is presented in Figure 2. 

 Figure 2 CFE respondents by stakeholder type 

As part of the 206 responses from companies/businesses, around 80% were SMEs, whose 
contributions are reflected in the analysis.  

2.4. Targeted surveys (TS) 

National competent authorities: Responses were obtained from 18 competent authorities: 
16  from  EU  Member  States,  1  from  an  EEA  country  and  one  from  a  Customs  Union 
country. Each Member State was permitted to provide one response only. 

Economic operators (EOs): Responses were obtained from 254 EOs, 202/254 or 79.5% of 
which were EU-based EOs and 52/254 or 20.5% were based outside the EU. 235/254 or 
92.5%  of  these  EOs  were  registered  in  EUDAMED,  and  their  stakeholder  type  as 
registered in EUDAMED is shown below:  

104 

 
 
 
Figure 3 Stakeholder type at EUDAMED registration 

A  majority  of  responses  were  received  from  small  and  medium-sized  enterprises 
(SMEs) (174/254 or 68.5%), as well as 80/254 or 31.5% of the EOs that can be designated 
as large (250 or more employees). Of note, Medtech Europe reports that 90% of medical 
technology  companies  are  SMEs  in  the  EU279,  suggesting  that  SMEs  were  under-
represented  in  the  targeted  survey  sample.  The  average  number  of  staff  employed  for 
regulatory  compliance  with  MDR  and  IVDR  counted  in  Full  Time  Equivalents  (FTE) 
employed on 31/10/2024 is 20 for SMEs and 167 for large companies.  

Notified  Bodies  (NBs): Responses  were  obtained  from  50  notified  bodies,  of  which  the 
majority (37/50 or 74%) were designated under MDR only, a smaller proportion (12/50 or 
24%) were designated under both  the MDR  and IVDR, and just one notified body was 
designated under IVDR only. 

European Medicines Agency (EMA): One response was collected from the EMA.  

Governance study: Information on the survey and interview respondents can be found in 
the published report.280  

2.5. Ad hoc contributions: position papers (PP) 

Both  position  papers  and  literature  articles  were  received  for  analysis.  Among  the  211 
position  papers,  12  duplicates  were  identified,  7  files  were  submitted  in  formats 
incompatible with the analysis methods (such as image and message files), and one file 
was  corrupted.  In  addition,  a  total  of  26  literature  articles  were  submitted,  including  5 
project deliverables and 13 publications from the CORE-MD consortium. The literature 

279 MedTech Europe website, Facts and Figures 2024. 
280 See note 91, page 18.  

105 

                                                                                                                                                                                                    
 
 
 
articles did not require cleaning. In total, 217 files were available for analysis. The majority 
of the materials date from recent years; 65 (30%) in 2025, 54 (25%) in 2024, 39 (18%) in 
2023,  8  (4%)  in  2022,  9  (4%)  in  2021  and  the  remaining  articles  had  been  published 
between 2008 and 2020.  

3. DISCUSSION OF RESULTS 

3.1. Effectiveness 

Just under half of the respondents to the PC agreed that the Regulations have contributed 
to protecting the health of patients and have contributed to protecting the health of 
users (MDR: 46% or 110/240 for patients and 40% or 95/240 for users; IVDR: 44% or 
50/113 for patients and 35% or 40/113 for users)281. While there were some differences in 
percentages  across  stakeholder  groups,  no  explicitly  disagreeing  views  were  observed 
across groups. Meaningful comparisons were difficult due to varying response numbers 
per stakeholder group; NBs, public authorities, and patient organisations appeared to view 
the MDR's effectiveness in protecting the health of patients and users more positively, but 
their low response rates limit data reliability. A small number of EU citizens responded to 
the public consultation,  and they were slightly  more positive about  the  effectiveness  of 
MDR/IVDR in protecting health: 67% (14/21) agreed that MD/IVD are regulated in a way 
that contributes to a high level of health protection.  

253  feedback  responses  to  the  CfE  discussed  the  impact  of  the  Regulations  on  patient 
health.  44.3%  (112  entries282)  of  these  responses  discussed  reduced  patient  access  to 
medical  devices,  innovative treatments,  or diagnostics, and the negative  impact  on care 
resulting  from  the  MDR/IVDR.  30.8%  (78  entries283),  discussed  how  the  increased 
administrative  or  financial  burden  did  not  result  in  clear  patient  benefits.  Some 
stakeholders also raised the Regulations’ failure to improve patient safety or create benefits 
for patients (89 entries284, 35.1%). However, 29 entries285 (11.5%) acknowledge that the 
Regulations  improve  safety,  transparency,  or  quality  standards.  36  feedback  entries286 
(14.2%) discuss the withdrawal of niche or rare disease products, impacting patients with 
specific  needs.  Stakeholders  raised  similar  concerns  in  the  position  papers,  discussing 
delays in device availability, increased bureaucracy, and negative impacts on patient care, 
particularly for rare diseases and paediatric needs.  

281 “I do not know/not applicable" respondents are included in the total. 
282 45 from Company/Business, 30 from Health Providers, 15 from EU Citizens, 10 from Business Associations, 5 from 

Patient Organisations, 4 from NGOs, 3 from Academic/Research Institutions. 

283 35 from Company/Business, 20 from Health Providers, 10 from EU Citizens, 8 from Business Associations, 3 from 

Academic/Research Institutions, 2 from NGOs. 

284 40 from Company/Business, 20 from Health Providers, 10 from EU Citizens, 8 from Business Associations, 6 from 

Academic/Research Institutions, 3 from NGOs, 2 from Non-EU Citizens. 

285 10 from Business Associations, 8 from Company/Business, 5 from Health Providers, 3 from Public Authorities, 2 

from NGOs, 1 from Academic/Research Institutions. 

286 15 from Company/Business, 10 from Health Providers, 5 from Patient  Organisations, 3 from EU Citizens, 2 from 

NGOs, 1 from Public Authorities. 

106 

 
 
 
 
Regarding  the  functioning  of  the  Union  market,  respondents  to  the  PC  did  not  see  the 
effectiveness  of  the  Regulations  in  creating  an  even  playing  field  for  health 
institutions and in creating an even playing field for EOs (MDR: 10% or 23/240 for 
health institutions and 10% agreement or 24/240 for EOs; IVDR: 9% or 10/113 for health 
institutions and 6% or 7/113 for EOs)287. As these figures show, scepticism was slightly 
higher regarding the effectiveness of the IVDR in creating an even playing field, compared 
to the MDR. The low level of support for the effectiveness of the MDR/IVDR in creating 
an  even  playing  field  was  present  across  stakeholder  types288.  Feedback  to  the  CfE 
discussed the contributions of inconsistencies in the interpretation, implementation, and 
costs of MDR/IVDR Regulations across Member States and NBs in creating an uneven 
playing  field  (112  out  of  176  entries289,  63.7%)  The  position  papers  discuss,  across 
stakeholder  types,  the  challenges  and  inconsistencies  in  implementing  the  MDR  and 
IVDR. This undermines the goal of creating a level playing field for economic operators, 
identifying  the  size  of  a  company,  type  of  product,  risk  class,  location/Member  States, 
choice of NB, and inconsistent interpretations as factors which influence the playing field. 
In line with this, respondents to the PC were doubtful of the Regulations’ effectiveness in 
ensuring the rules were applied fairly and impartially both before and after a device is CE-
marked (24% and 29% respectively for MDR; 19% and 21% respectively for IVDR). Both 
the CfE and position papers (across all stakeholder groups) discussed the disproportionate 
impact  on  SMEs  and  start-ups  because  of  relatively  high  compliance  costs  and 
administrative burdens compared to larger companies (67 out of 176 entries290, 38.1% in 
the CFE).  

There  is  broad  consensus  that  the  MDR  and  IVDR  regulatory  frameworks  do  not 
adequately support innovation.  In the PC survey, just 1% or 3/240 agreed that the MDR, 
and 2% or 2/113 that the IVDR, supported innovation. 243 feedback responses291 to the 
CfE (out of 360, 67.5%) reported the MDR/IVDR hinders innovation due to the regulatory 
burdens  they  impose.  Challenges292  cited  include  excessive  documentation  and  unclear 
requirements,  which  stakeholders  find  divert  resources  from  R&D  to  regulatory 
compliance. 78 entries293 (out of 360, 21.7%) discuss lengthy certification timelines and 
their impact on innovation. Stakeholders find the Regulations discourage incremental and 
breakthrough innovations, delays market entry, and drives companies to prioritise non-EU 

287 “I do not know/not applicable" respondents are included in the total. 
288 Based on an analysis of the stakeholder types for which a sufficient number of responses was available to make a 

reliable judgement.  

289 48 from Company/Business, 22 from Business Association, 15 from Health Provider, 10 from EU Citizen, 6 from 

Other, 5 from Academic/Research Institution, 3 from NGO, 2 from Public Authority, 1 from Trade Union. 

290  38  from  Company/Business,  12  from  Business  Association,  7  from  EU  Citizen,  5  from  Health  Provider,  3  from 

Academic/Research Institution, 2 from Non-EU Citizen. 

291 89 from Company/business; 47 from Health provider; 36 from EU Citizens; 28 from Business Association; 15 from 
Academic/Research Institution; 10 from Other; 7 from Non-EU Citizens; 6 from NGO; 3 from Public authority; 2 
from Trade Union; 1 from Patient organisation.  

292 CfE entries from EU citizens, health providers, company/businesses. 
293 34  from  Company/business;  16 from  Health  provider; 12  from Business  Association;  8  from  EU  Citizen;  5  from 

Academic/Research Institution; 3 from Other.   

107 

 
 
 
markets like the U.S. and Asia (64 out of 360 entries294, 17.8%). 112 entries295 (31.1%) 
discussed the disproportional impact of the Regulations on SMEs and start-ups.  

In line with  this,  the position  papers analysis  also  revealed that stakeholders (across all 
stakeholder groups) are critical of the MDR and IVDR frameworks for stifling innovation, 
particularly  for  SMEs,  startups,  and  low-risk  devices.  Common  concerns  include  high 
costs, administrative burdens, lengthy approval processes, and regulatory unpredictability, 
which  stakeholders  feel  divert  resources  away  from  R&D,  delay  market  access,  and 
encourage  a  shift  of  innovation  activities  to  more  predictable  markets  like  the  United 
States.  

The position papers and CfE analyses revealed consensus that the MDR and IVDR, and 
their financial and regulatory burdens,  disproportionately  affect SMEs. 85.5% of CfE 
feedback responses which discussed impacts of the Regulations on SMEs (278 out of 325 
entries296) discussed the disproportionate financial and administrative burdens of the MDR 
and IVDR on SMEs. Recurring themes in both the position papers and CfE include high 
certification  costs,  resource  constraints,  lengthy  approval  timelines,  and  complex 
documentation requirements, which hinder innovation, can lead to product withdrawals, 
and drive some SMEs out of the market. In the position papers analysis, one manufacturer 
association  report  states  that  77%  of  companies  responding  to  their  survey  reported 
negative  effects  of  the  MDR  on  their  innovation  activities.'297 Another  such  association 
reports that '47.6% of large manufacturers and 54.4% of SMEs reported decreases in new 
medical device development'.298 A peer-reviewed article reports ‘about one-third of those 
surveyed  indicated  that  they  are  having  difficulty  bringing  innovative  products  to  the 
market because of the MDR.'299 

At the time of this study’s implementation of the MDR/IVDR—when EUDAMED and the 
traceability requirements under the Regulations are not yet fully in place—only a small 
proportion  of  stakeholders  in  the  PC  considered  the  Regulations  to  be  effective  in 
enhancing the transparency of devices and the traceability of devices within the EU 
(MDR:  28%  or  66/240  agreement  for  transparency  and  39%  or  93/240  agreement  for 
traceability;  IVDR:  19%  or  22/113  agreement  for  transparency  and  23%  or  26/113 
agreement for traceability). The most commonly referenced transparency issue in the CfE 
feedback responses (34 out of 121 entries referencing transparency300, 27.9%) called for 
improved transparency in EUDAMED. The position papers support (across all stakeholder 
types) the MDR’s and IVDR's goals to enhance transparency through EUDAMED, UDI, 

294 28 from Company/business; 12 from EU Citizen; 10 from Health provider; 8 from Business Association; 4 from Non-

EU Citizen; 2 from Other.   

295 52 from Company/business; 18 from Health provider; 14 from Business Association; 10 from EU Citizen; 8 from 

Academic/Research Institution; 6 from Other; 4 from Non-EU Citizen. 

296 120: Company/Business; 45 EU Citizen; 35 Business Association; 30 Health Provider; 15 Other; 10 Non-EU Citizen: 
8 Academic/Research Institution; 5 NGO; 4 Public Authority; 3 Trade Union; 2 Patient Organisation;  1 Consumer 
Organisation.  

297  Position paper of manufacturer. 
298  Position paper of manufacturer association. 
299  Position paper of academic. 
300 10 Business, 8 Health Providers, 6 Business Associations, 4 EU Citizens, 3 NGOs, 2 Academics, 1 Public Authority 

108 

 
 
 
and public access to clinical data, and equally find EUDAMED's full implementation is 
critical for improving traceability and accessibility of safety and performance data.  

42  CfE  respondents301  (out  of  87  entries,  48.2%)  expressed  a  lack  of  trust  in  the 
regulatory framework —both in its outcomes and in the framework itself. The position 
papers emphasise the importance of trust in the regulatory framework for medical devices, 
focusing  on  transparency,  rigorous  evidence,  harmonised  implementation,  and  robust 
oversight.  One  paper  notes  that  the  inefficiencies  and  unpredictability  of  the  MDR  and 
IVDR  have  eroded  trust  in  the  system  among  stakeholders,  including  patients  and 
manufacturers: 'This affects confidence and trust in the system, its stakeholders and the 
reliability of medical devices approved under the system.'302 

As the results above show, stakeholders view the MDR and IVDR as having failed to meet 
their objectives, notably in terms of supporting innovation and creating an even playing 
field  for  health  institutions  and  EOs.  In  addition,  there  is  evidence  to  suggest  that  the 
Regulations may have had unintended effects. Both the CfE and position papers analyses 
highlight  the  negative  impact  of  the  MDR  and  IVDR  on  the  availability  of  medical 
devices.  393  feedback  responses303  to  the  Call  for  Evidence  highlight  concerns  about 
reduced  availability  of  medical  devices  due  to  stringent  MDR  and  IVDR  regulations. 
Indeed,  a  survey  by  a  health  professional  association  found  that  49%  of  clinician 
respondents  in  Europe  confirmed  issues  with  medical  device  availability  (number 
unknown),  with  particular  impact  on  certain  subspecialities  such  as  paediatric 
cardiology.304  61%  of  European  hospital  pharmacists  survey  respondents  (N=1251) 
indicated  that  medical  devices  shortages  are  a  problem  in  their  hospital.305  Of  the  393 
feedback  responses  to  the  CfE,  70%  (278  feedback  responses306)  referenced  market 
withdrawal of devices due to high compliance costs, lengthy certification processes, and 
limited NB capacity. Stakeholders cited different figures related to withdrawals in both the 
CfE  feedback  and  position  papers:  data  from  various  sources  provided  by  stakeholders 
suggested that between 46% (n unknown) and 54% (N=68) of manufacturers are planning 
to  stop  (or  had  stopped)  producing  or  marketing  some  medical  devices  in  Europe.307 
According  to  a  manufacturers  association,  58%  of  manufacturers  that  discontinue  their 
products  in  the  EU  will  continue  to  sell  these  products  outside  of  the  EU  (N=393).308 
Various figures are provided on the potential decreases in availability of medical devices 

301 15 from Company/Business, 9 from EU Citizens, 7 from Health Providers, 6 from Business Associations, 3 from 

Non- EU Citizens, 2 from NGOs. 

302  Position paper of manufacturer association. 
303  139  company/businesses,  76  health  providers,  62  EU  citizens,  40  business  associations,  22  other,  18 
academic/research institutions, 9 NGOs, 8 non-EU citizens, 7 public authorities, 5 patient organisations, 3 consumer 
organisations, 2 trade union, and 2 notified bodies. 

304 CfE of health provider. 
305 Position paper of pharmacists. 
 306  This figure contains feedback from the following groups: 96 from Company/Business; 58 from Health Providers; 42 
from EU Citizens; 34 from Business Associations; 18 from Other; 10 from Academic/Research Institutions; 8 from 
NGOs; 6 from Public Authorities; 4 from Patient Organisations; 2 from Consumer Organisations.   

307 Study conducted by Gesundheid Österreich. Mentioned in CfE of health provider;  3 position papers of academics; 

position paper of manufacturer association.  

308  Position paper of manufacturer. 

109 

 
 
 
(withdrawal of between 20 - 53% of current products)309 and IVDs (withdrawal of between 
17 - 22% (of current products)310, often presented in direct connection to the MDR and 
IVDR’s bureaucratic burden.  

3.2. Efficiency 

The CfE and position papers analyses revealed significant administrative burdens under 
the  MDR  and  IVDR,  emphasising  inefficiencies,  delays,  and  resource-intensive 
processes.  

In  the  CfE,  183311  of  221  respondents  (82.8%)  explicitly  criticise  the  excessive 
administrative burdens and documentation requirements under MDR and IVDR. Excessive 
documentation,  redundant  processes,  and  unclear  guidance  were  generally  highlighted. 
Respondents  emphasised  the  need  for  digitalisation,  harmonisation,  and  streamlined 
processes  to  reduce  costs  and  resource  strain:  46  entries312  (20.8%)  advocate  for 
digitalisation and streamlined processes to reduce administrative burdens. All stakeholders 
agree  on  the  importance  of  EUDAMED  and  it  is  seen  as  a  critical  tool  for  improving 
transparency  and  efficiency,  but  its  incomplete  rollout  exacerbates  challenges:  97 
respondents313 (43.9%) highlight delays, inefficiencies, or incomplete functionality of the 
EUDAMED database.  

The position papers analysis mirrors these views. Significant administrative burdens are 
cited,  such  as  extensive  documentation,  which  strain  resources.  For  example,  a 
manufacturer  association survey reports that 52% of the respondents  (to the 2023-2024 
survey) declared that the average certification time is in the range 13-18 months. A further 
22% of respondents  declared that this time is  in  the range 19-24 months.314 Concerned 
stakeholders advocate for digitalisation, streamlined processes, and centralised systems to 
reduce  redundancies  and  improve  efficiency.  A  recurring  focus  on  the  delayed 
implementation and inefficiencies of the EUDAMED database also features in the position 
papers  analysis.  Differences  emerge  in  focus  areas:  manufacturers  emphasise  the 
disproportionate  impact  on  SMEs  and  innovation,  while  healthcare  professionals  and 
insurers prioritise transparency and data accessibility. Patients and public authorities stress 

309  Position paper of manufacturer; position paper of healthcare professional. 
310 
healthcare 

professional 

Position 

Study 

paper 

of 

performed 

by  MedTech  Europe 

(see 

https://www.medtecheurope.org/wp-content/uploads/2021/09/medtech-europe-survey-report-detailed-results.pdf) 
mentioned in: CfE of health provider and CfE of company/business. 

311 63 from Company/Business, 33 from Health Providers, 28 from Business Associations, 22 from EU Citizens, 12 from 
Other, 8 from Academic/Research Institutions, 6 from Non-EU Citizens, 5 from NGOs, 4 from Public Authorities, 
2 from Trade Unions, 2 from Consumer Organisations, 0 from Patient Organisations. 

312 21 from Company/Business, 10 from Business Associations, 6 from Health Providers, 4 from EU Citizens, 3 from 
Other, 1 from NGOs, 1 from Academic/Research Institutions, 0 from Non-EU Citizens, 0 from Public Authorities, 
0 from Trade Unions, 0 from Consumer Organisations, 0 from Patient Organisations. 

313 38 from Company/Business, 18 from Health Providers, 15 from Business Associations, 10 from EU Citizens, 6 from 
Other, 4 from Academic/Research Institutions, 3 from NGOs, 2 from Non-EU Citizens, 1 from Public Authorities, 
0 from Trade Unions, 0 from Consumer Organisations. 

314 Position paper of manufacturer association. 

110 

 
 
 
 
the importance of EUDAMED for safety and traceability but note current limitations such 
as information gaps or limited staff capacity that prevent full functionality.  

In the public consultation, perceptions of the acceptability of the administrative costs and 
compliance costs associated with the MDR and IVDR were quite negative. For Phase 1315 
and Phase 2316  activities, no more than 10% of respondents agreed that the administrative 
and compliance costs were acceptable. For Phase 3317 and Phase 4318 activities, perceived 
acceptability of costs was slightly higher for the MDR but not for the IVDR.  

Phase 1 

Phase 2 

Phase 3 

Phase 4 

Administrative
: 11/240 or 5% 
Compliance: 
15/240 or 6% 

Administrative
: 9/240 or 4% 
Compliance: 
10/240 or 4% 

Administrative
:28/240 or 12% 
Compliance: 
31/240 or 13% 

Administrative:25/
240 or 10% 
Compliance: 
36/240 or 15% 

Administrative
: 10/113 or 9% 
Compliance: 
11/113 or 10% 

Administrative
: 7/113 or 6% 
Compliance: 
7/113 or 6% 

Administrative
: 10/113 or 9% 
Compliance: 
12/113 or 11% 

Administrative: 
5/113 or 4% 
Compliance:  9/113 
or 8% 

of 

Level 
agreement 
that… 
…the 
administrative/ 
compliance 
costs  associated 
with  the  MDR 
are acceptable  
…the 
administrative/ 
compliance 
costs  associated 
with  the  IVDR 
are acceptable 

Perceptions about the likelihood of costs decreasing were pessimistic: less than 10% of 
respondents  believed  the  costs  resulting  from  the  MDR  would  decrease  once  the 
Regulation  was  fully  implemented,  apart  from  Phase  4,  about  which  respondents  were 
slightly  more  optimistic  (10-15%)319.  For  the  IVDR,  respondents  were  slightly  more 
optimistic about  the costs for Phases 1  and  4 decreasing  once the  Regulation  was  fully 
implemented (10-15%) but were pessimistic about the costs for Phases 2 and 3 (less than 

315 The survey question described the activities to be considered for phase 1 as follows: activities related to generating 
evidence on the safety and performance of devices; activities related to clinical investigations; activities related to 
setting up quality management systems; activities for the designation of notified bodies under the Regulation. 
316 The survey question described the activities to be considered for phase 2 as follows: activities concerning the initial 
certification of devices and the maintenance of certificates; activities concerning the first placing on the market or 
putting into service devices for which the conformity assessment does not involve a notified body; activities related 
to derogations to the conformity assessment. 

317 The survey question described the activities to be considered for phase 3 as follows: Activities for the compliance 

with post market obligations; activities related to vigilance; activities related to market surveillance. 

318  The  survey  question  described  the  activities  to  be  considered  for  phase  3  as  follows:  Activities  for  providing 

information on devices or certificates; activities providing guidance to the sector. 

319 Agreement that administrative cost will decrease MDR Phase 1: 19/240, Phase 2: 14/240, Phase 3: 19/240, Phase 4: 
33/240. Agreement that administrative cost will decrease MDR Phase 1: 20/240, Phase 2: 19/240, Phase 3: 17/240, 
Phase 4: 35/240. 

111 

 
 
 
 
 
10%).320 While optimism about costs decreasing was low across all stakeholder groups321, 
there  were  some  differences  in  patterns  across  phases.  For  both  the  MDR  and  IVDR, 
Notified Bodies were more optimistic about the costs decreasing for Phase 4 than for all 
other phases, health providers were most optimistic about costs decreasing for Phase 1 and 
public authorities were least optimistic about costs decreasing for Phase 3.   

There was a perceived  mismatch between the level  of regulatory burden and the actual 
risks  involved  in  certain  contexts.  In  the  CfE  analysis,  65  entries322  (19.7%)  found  the 
frameworks lack proportionality for specific contexts, highlighting the need for risk-based, 
context-specific  approaches.  As  one  company  explained:  “even  for  low-risk,  well-
established  products,  the  volume  and  complexity  of  required  documentation  is 
overwhelming”. 

In  the  CfE  analysis,  278323  of  325  feedback  responses  (85.5%)  discussed  the 
disproportionate financial and administrative burdens of the MDR and IVDR on SMEs in 
particular. Recurring themes include high certification costs, resource constraints, lengthy 
approval timelines, and complex documentation requirements, which hinder innovation, 
can lead to product withdrawals, and drive some SMEs out of the market. Similarly, in the 
position papers analysis, the impact on SMEs was highlighted, with stakeholders sharing 
concerns  about  increased  certification  costs,  limited  access  to  NBs  in  the  first  years  of 
MDR and IVDR implementation, and reduced innovation, leading to SMEs withdrawing 
products  or  deprioritising  the  Union  market.  Manufacturers,  insurers,  and  healthcare 
professionals highlight the financial strain and market exits, while academics and NGOs 
emphasize the stifling of innovation and competitiveness.  

The analysis of the EO survey pointed to differences in costs based on manufacturer 
size (SME versus  large). Taking  the  example  of QMS  certificates for  annex  IX  (there 
were  insufficient  datapoints  to  analyse  the  results  for  annex  XI  by  size),  the  average 
issuance costs charged to the EO during the period 01/01/2022 - 31/10/2024 were 641,878 
EUR (N = 25) for first certificates and 882,988 EUR (N = 56) for last certificates. Figure  
shows how the costs vary by manufacturer size with large manufacturers (N = 33) paying 
significantly more than SME (N = 23) for the last QMS certificate (percentage difference 
of  165.06%).  Costs  for  hiring  an  external  consultant  follow  the  same  pattern,  for  last 
certificate issuance the percentage difference between SMEs and large manufacturers is 

320 Agreement that administrative costs will decrease IVDR Phase 1: 15/113, Phase 2: 10/113, Phase 3: 8/113, Phase 4: 
18/113. Agreement that complying cost will decrease IVDR Phase 1: 17/113, Phase 2: 11/113, Phase 3: 9/113, Phase 
4: 20/113. 

321 Based on an analysis of the stakeholder types for which a sufficient number of responses was available to make a 

reliable judgement. 

322 30 from Company/Business, 15 from Health Providers, 10 from Business Associations, 5 from EU Citizens, 3 from 
Academic/Research Institutions, 2 from Other. Note that these comments were originally classified as being related 
to relevance, but were judged to be more relevant to efficiency. The percentage (19.7%) is based on the total number 
of entries to the CfE.  

323 120: Company/Business; 45 EU Citizen; 35 Business Association; 30 Health Provider; 15 Other; 10 Non-EU Citizen: 
8 Academic/Research Institution; 5 NGO; 4 Public Authority; 3 Trade Union; 2 Patient Organisation;  1 Consumer 
Organisation. 

112 

 
 
 
185.20%. However, due to low response rate, this cost variation due to manufacturer size 
should be interpreted with caution.  

Figure 4 Average costs (€) for QMS Annex IX certificates under MDR, by manufacturer 
size 

3.3. Relevance  

Respondents to the PC were sceptical about the relevance of the MDR/IVDR to emerging 
health  challenges  and  evolving  patient  needs  (51/240  or  21%  agreement  for  the  MDR; 
18/113  or  16%  agreement  for  the  IVDR).  Although  respondents  were  slightly  more 
positive about the relevance of the MDR/IVDR to cybersecurity324, they were sceptical that 
the Regulations were relevant to emerging future technological and scientific innovation 
in  the  sector  (4%  and  8%  agreement,  respectively).  In  line  with  this,  48  CfE  feedback 
responses325 (13.6%) discuss misalignment of the Regulations with emerging technologies 
and  needs.  Concerns  include  inadequate  support  for  emerging  technologies  such  as  AI, 
digital  health,  personalised  medicine,  genomics,  3D  printing  and  software  as  medical 
device  (SaMD).  This  feedback  contrasts  with  the  Regulations’  objectives  related  to 
ensuring  the  availability  of  safe  and  performant  devices,  the  smooth  functioning  of  the 
internal  market,  and  support  to  innovation  and  competitiveness,  which  stakeholders 

324  Public  consultation: 71/240  respondents  or 30%  and  40/113  respondents  or 35%  agreeing  that  cybersecurity  was 

addressed in the MDR and IVDR, respectively. 

325 25 from Company/Business, 10 from Health Providers, 5 from Academic/Research Institutions, 4 from NGOs, 3 from 

Other, 1 from EU Citizens. 

113 

                                                                                                                                                                                                                 
 
 
 
 
acknowledge  remain  relevant  but  insufficiently  realised  in  practice.    Stakeholders  also 
highlighted that the lack of proportionate pathways – particularly affecting the SMEs, start-
up, and niche or orphan devices – risks undermining access to critical technologies and 
weakens the sector’s capacity to respond to evolving patient needs and health challenges. 
To overcome the lack of clarity in the regulatory framework, the feedback highlighted the 
need  for  clear  and  precise  guidelines,  for  emerging  technologies.  The  position  papers 
analysis was aligned with this.  

3.5. Coherence  

35%  (84/240)  of  respondents  to  the  PC  agreed  that  the  provisions  in  the  MDR  are 
internally coherent, and 33% (78/240) agreed that the provisions of the MDR are coherent 
with the provisions of the IVDR. The same proportion (35%, 39/113) of respondents to the 
PC  agreed  that  the  provisions  in  the  IVDR  are  internally  coherent,  and  44%  (50/113) 
agreed that the provisions of the IVDR are coherent with the provisions of the MDR. Only 
one position paper cited an example of incompatible provisions: ‘[Provisions in Annex X, 
Art. 10 c, Article 20, and Annex X] were mutually incompatible and contradictory; their 
net result has been that in Europe no details of the regulatory review of clinical evidence 
relating to medical devices have been disclosed.'326 In the CfE, no internal coherence issues 
were explicitly identified. 

Perceptions of the  external  coherence  of the MDR  varied according to  the Regulation 
with which it was being compared. Respondents to the PC were most likely to agree that 
the MDR was coherent with other EU rules in the field of market surveillance (33% or 
78/240)  and  packaging  and  labelling  (34%  or  81/240),  and  least  likely  to  agree  it  was 
coherent with other regulations in the field of eco-design (4% or 10/240). Respondents to 
the PC were most likely to agree that the IVDR was coherent with other EU rules in the 
field of cybersecurity (34% or 39/113) and market surveillance (31% or 35/113), and least 
likely  to  agree  it  was  coherent  with  other  regulations  in  the  field  of  eco-design  (4%  or 
4/113).  

109  feedback  responses  to  the  Call  for  Evidence  discussed  the  external  coherence  and 
alignment in the MDR and IVDR regulatory frameworks. 58 of these feedback responses 
327 (53.2%) explicitly highlight misalignment or overlaps with other EU regulations (e.g., 
Artificial Intelligence Act328 (AI Act), General Data Protection Regulation329, the Clinical 
Trials  Regulation330  (CTR)  and  environmental  legislation).  The  position  papers  call  for 
better alignment between the MDR and IVDR and other frameworks, such as the AI Act331, 

326 Position paper of academic. 
327  20  from  Business  Associations,  18  from  Companies,  10  from  Health  Providers,  5  from  Academic/Research. 

Institutions, 3 from NGOs, 2 from Public Authorities. 

328 Regulation (EU) 2024/1689, OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj.   
329 Regulation (EU) 2016/679, OJ L 119, 4.5.2016, pp. 1–88, ELI: http://data.europa.eu/eli/reg/2016/679/oj. 
330 Regulation (EU) No 536/2014, OJ L 158, 27.5.2014, pp. 1–76, ELI: http://data.europa.eu/eli/reg/2014/536/oj. 
331 2 position papers of manufacturer associations. 

114 

 
 
 
GDPR332, and pharmaceutical legislation333,334,335, to reduce overlaps, contradictions, and 
administrative burdens. One position paper from a business association indicated that 58% 
of  companies  are  concerned  about  the  high  level  of  complexity  between  the  MDR  and 
other regulations.336 34 CfE feedback responses337 (31.2%) emphasise the need to integrate 
horizontal frameworks (e.g., AI Act, sustainability, cybersecurity) to avoid contradictory 
requirements. 

Based on European Commission services experience, future reflections on coherence and 
interplay between MDR/IVDR and the following frameworks can be considered:  

•  The Ecodesign for Sustainable Products Regulation (ESPR)338 aims to enhance the 
sustainability  of  certain  products  on  the  EU  market.  Unlike  food  and  medicinal 
products, medical devices and IVDs are not exempt. When setting the potential ESPR 
requirements (such as on durability, reusability, environmental impact etc.), the need 
to not negatively affect the health and safety of patients and users should be taken into 
account.  The  phased  introduction  of  ESPR  requirements  could  eventually  apply  to 
medical devices, though the timeline remains uncertain. 

•  The Basic Safety Standards Directive (BSSD)339 aims to ensure, among others, that 
patients are protected against the dangers arising from exposure to ionising radiation, 
including  by  setting  requirements  for  the  use  of  medical  devices  emitting  ionising 
radiation (in radiology, radiotherapy, nuclear medicine). With respect to the interplay 
with  MDR,  activities  such  as  acceptance  and  performance  testing  of  devices,  or 
vigilance  and  surveillance,  call  for  cooperation  between  radiation  protection  and 
medical devices authorities. The interplay between BSSD and MDR is currently being 
investigated in the “SAMIRA MD study” under the SAMIRA Action Plan340.  

3.6. EU added value  

Respondents to the public consultation agreed that it was preferable to have a single EU 
regulation  in  this  field  instead  of  individual  national  regulations  (93%  or  224/240  of 
respondents for MDR, 87% or 98/113 of respondents for IVDR). In line with this, in the 
position papers, stakeholders broadly agree that a unified regulatory framework enhances 
patient safety, supports innovation, and strengthens the EU's global competitiveness. The 

332 Position paper of manufacturer (large). 
333 Position paper of European body. 
334 Position paper of manufacturer (large). 
335 Position paper of manufacturer (SME). 
336 Position paper of manufacturer. 
337 12 from Business Associations, 10 from Companies, 6 from Health Providers, 3 from Public Authorities, 2 from 

Notified Bodies, 1 from Trade Union. 

338  Regulation (EU) 2024/1781 OJ L, 2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj. 
339 Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against 
the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 
96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. 

340 European Commission website, Radiological and nuclear technology in health, SAMIRA Action Plan. 

115 

 
 
 
 
CE  mark  and  centralised  governance  are  seen  as  valuable  tools  for  market  access  and 
efficiency. 

However, although there was support for the idea of a single EU Regulation in principle, 
there  were  mixed  views  about  the  added  value  of  the  MDR  and  IVDR  in  terms  of  its 
effectiveness. Overall, 98 feedback responses to the CfE highlight concerns about the EU 
added value of the regulations. From the analysis of these feedback responses, the term 
“EU added value” was understood by stakeholders both in the sense of the EU as a market 
and  in  terms  of  EU  regulations  to  regulate  medical  devices.  Recurring  themes  include 
critiques of the regulations for stifling innovation, increasing costs, and driving companies 
to non-EU markets, which undermines the EU’s competitiveness and added value. 

Recurring themes around EU added value in the position papers analysis include the EU's 
leadership in harmonising the laws governing medical devices on the Union market under 
MDR  and  IVDR,  fostering  innovation,  and  ensuring  safety  and  access  to  medical 
technologies.  However,  frequent  critiques  highlight  the  MDR’s  and  IVDR's  stringent 
requirements,  which  are  seen  as  burdensome,  hindering  innovation,  delaying  market 
access,  and  driving  companies  to  non-EU  markets.  Commonalities  among  stakeholders 
include  recognition  of  the  EU's  role  to  create  harmonised  laws  under  one  regulation, 
ensuring safety, and fostering innovation.  

On the other hand, a large proportion of PC respondents agreed that the MDR and IVDR 
decreased compliance and administrative costs compared to having to comply with a 
different set of rules at the national level (MDR: 49% or 117/240 agreement with decreased 
compliance  costs  and  50%  or  119/240  agreement  for  decreased  administrative  costs; 
IVDR:  58%  or  65/113  agreement  for  decreased  compliance  costs  and  56%  or  63/113 
agreement for decreased administrative costs). On the other hand, around half of the PC 
respondents  believed  that  it  was  feasible  to  maintain  adequately  safe  devices  while 
reducing costs (45% or 109/240 agreement for the MDR; 42% or 48/113 agreement for the 
IVDR).

116 

 
ANNEX VI. EFFECTIVENESS TABLES: EVIDENCE AND SCORING 

To synthesise findings across diverse sources, the evaluation applies a five-point ordinal scale consistent with Tool #47 on proportionality:  

•  ++ Strong positive impact  

•  + Some positive impact  

•  0 Neutral/mixed impact  

• 

• 

- Some negative impact  

-- Strong negative impact  

Scores are assigned per evaluation question and then synthesised at section and criterion level. The scoring is qualitative but evidence-based: it is not 
mechanically derived from percentages but reflects a reasoned judgement through triangulation.  

Applying a scoring system across all impacts ensures that findings from very different types of evidence can be compared in a transparent and proportionate 
manner. The MDR and IVDR generate a wide variety of effects: some are quantifiable (e.g. certification fees), while others are qualitative (e.g. perceived 
legal certainty, trust). Without a common framework, it would be difficult to synthesise these diverse results into an overall assessment of efficiency.  

The five-point ordinal scale provides such a framework. It allows evaluators to translate heterogeneous evidence into a comparable format, highlighting 
whether impacts are positive or negative and to what extent. This ensures that the evaluation captures not only the magnitude but also the direction of 
change. Importantly, the scores are not a mechanical output of survey percentages; they reflect a reasoned judgement through  triangulation of multiple 
sources, consistent with the Better Regulation Toolbox.  

This approach offers several advantages:  

•  Transparency: stakeholders can clearly see how different impacts have been weighed and judged.  

•  Comparability: results across stakeholder groups and regulatory areas can be aligned on a single scale, allowing for cross-cutting synthesis.  

117 

 
•  Proportionality: the scoring highlights which impacts are most significant, ensuring that minor issues do not overshadow major burdens or benefits.  

At the end of the analysis, results are synthesised in an overview table, which shows:  

•  Each evaluation criterion  

•  Sub-sections/questions under it  

•  The assigned scores (--/–/0/+/++)  

•  Key supporting evidence 

Legend: 

-  CAPA: Corrective and Preventative Action 
-  CECP/PECP: Clinical/Performance Evaluation Consultation Procedure 
-  CEF: Compliance Exchange Form 
-  CEN: European Committee for Standardization 
-  CENELEC: European Committee for Electrotechnical Standardization 
-  CER/PER: Clinical/Performance Evaluation Report 
-  CfE: Call for Evidence 
-  CI: Clinical Investigation 
-  DA: Designating Authority 
- 
-  EC: European Commission  
-  EMA: European Medicine Agency 
-  EO: Economic Operators 

e-IFU: Electronic Instruction of Use 

118 

 
 
 
 
IEC: International Electrotechnical Commission 
IMDRF: International Medical Device Regulators Forum 
ISO: International Organization for Standardization 
IVD: In Vitro Diagnostic Medical Devices 
IVDR: In Vitro Diagnostic Medical Devices Regulation 
JACOP: Joint Actions on Compliance of Products in the EU and EFTA countries 
JAMS: Joint Actions on Market Surveillance 
JAT: Joint Assessment Team 

-  EO survey: Economic operator survey’ conducted in the context of the Targeted Evaluation of the MDR and IVDR 
-  EPO: European Patents Office 
-  Eudamed: European database on medical devices 
-  FSCA: Field Safety Corrective Action 
-  FTE: Full-Time Equivalent 
-  Governance study: by Ernst and Young  
-  HCP: HealthCare Professional 
- 
- 
- 
- 
- 
- 
- 
- 
-  MD: Medical Devices 
-  MDR: Medical Devices Regulation 
-  MDCG: Medical Device Coordination Group 
-  MDSAP: Medical Device Single Audit Program 
-  MEDDEVs: guidance documents written by competent authorities under the Medical Devices Directives (MDD, AIMDD, IVDD) 
-  MIR: Manufacturer’s Incident Report 
-  MS: Market Surveillance  
-  MTE: MedTech Europe 
-  NB: Notified Body 
-  NB survey: Notified body survey conducted in the context of the Targeted Evaluation of the MDR and IVDR 
-  NBCG-Med: Notified Body Coordination Group 

119 

 
 
 
-  NBO: Notified Body Oversight working group within the MDCG 
-  NBOG: Notified Body Operations Group (NBOG). 
-  NC: Non-Conformity 
-  NCA: National Competent Authority 
-  NCA survey: Targeted national competent authority survey, conducted in the context of the Targeted Evaluation of the MDR/IVDR.  
-  OJEU: Official Journal of the European Union 
-  PC: Public Consultation 
-  PMS: Post-Market Surveillance 
-  PP: Position Papers 
-  PS: Performance Study 
-  PSR: Periodic Safety Report 
-  QMS: Quality Management System 
-  RC workshop: reality check workshop (with manufacturers or with healthcare professionals, users, patients) 
-  Vig: Vigilance 
-  WET: Well-Established Technology 
-  WG: Working Group 

120 

 
 
 
 
 
 
 
 
 
 
 
Table 1: Scoring of legal certainty, transparency and trust 

Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

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

• number of 
classification/qualification 
disputes (Article 52(3) 
and (4) MDR/47(3) and 
(4) IVDR) 
• volume of clarification 
requests to NCAs 

• Most countries report 
no increase in disputes; 
One Member State 
reported a decrease from 
77 (MDD/AIMDD) to 2 
(MDR/IVDR) (NCA 
survey) 
• 1263 disputes on which 
a court decision has been 
taken in relation to 
medical devices under 
MDD/AIMDD between 
2014 and 2021 (data 
from the NCA survey, 
13 respondents) 
• 34 disputes on which a 
court decision has been 
taken in relation to IVDs 
under IVDD between 

121 

• 86% of respondents state 
that unclear definitions, 
inconsistent 
interpretations, and vague 
guidance documents 
create legal uncertainty, 
while 61% of them 
highlight variability in 
interpretations by notified 
body and national 
authorities as causes that 
lead to inefficiency and 
unpredictability (CfE) 

• Widespread critique of 
ambiguous definitions, 

Overall 
assessment 
(scale --/-
/0/+/++) 

0 (neutral/mixed) 

Comments / data gaps 

• Despite missing data 
from several Member 
States, fewer national 
legal disputes in which 
a court decision was 
taken reported under 
the Regulations so far 
compared to the 
Directives. 

• Although quantitative 
trend suggests fewer 
disputes overall, 
qualitative evidence 
points to persistent 
uncertainty. 

• The Regulations 
introduced various EU 

 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

2014 and 2021 (data 
from the NCA survey, 5 
respondents) 
• 787 disputes on which 
a court decision has been 
taken in relation to 
medical devices under 
MDR between 2021 and 
2024 (data from the 
NCA survey, 13 
respondents) 
• 11 disputes on which a 
court decision has been 
taken in relation to IVDs 
under IVD between 2021 
and 2024 (data from the 
NCA survey, 5 
respondents) 
• 167 reported decisions 
taken on the 

inconsistent application 
across MS (PP) 

• 75% of respondents 
disagree or strongly 
disagree that a robust, 
transparent, predictable, 
and sustainable regulatory 
framework exists (MD), 
while 77% believe the 
same for IVD (PC) 

• approximately 40% of 
respondents believe that 
the guidance documents 
produced by MDCG 
enhance legal clarity on 
provisions of the 
Regulations (both MD 
and IVD), while 18% 

122 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

level procedures with 
the aim of enhancing 
legal certainty, for 
example classification 
disputes (Art. 52(3) and 
(4) MDR/47(3) and (4) 
IVDR) and to 
determine the 
regulatory status of 
products (Article 4 
MDR) i.e. qualification 
matters. 

• The impact of 
guidance on small 
economic operators is 
unknown and hard to 
estimate. 

 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

(MD) and 21% (IVD) are 
neutral (PC) 

• One third of 
stakeholders in the CfE 
call for clearer, 
harmonised, and binding 
guidance documents to 
reduce legal uncertainty 
and improve predictability 
under the MDR and 
IVDR, suggesting a 
centralised EU-level 
support or mediation to 
resolve disputes 

classification of devices 
in cases of a dispute 
between the MF and the 
NB under the 
MDD/AIMDD between 
2014 and 2021 (reported 
by 11 countries), while 
under MDR and IVDR 
the numbers dropped to 
23 and 3, respectively 
(NCA survey) 

• 50+ MEDDEV + 
NBOG documents (EC) 
• 600+ number of pages 
in the MEDDEV + 
NBOG documents (EC) 
• 100+ MDCG guidance 
docs issued since 2017 

123 

• number of guidance 
documents issued 
(MDCG) 
• perceived clarity of 
guidance 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

• Guidance volume is 
high, but clarity and 
consistency perceived 
as insufficient. 

• Helsinki procedure is 
not efficient: average 
number of countries 
that participate is 11 
and timeframe to reach 
a decision is too long. 

0/+ (mixed to 
some positive) 

 
 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

• 1500+ number of pages 
in the MDCG guidance 
documents (EC) 

• Helsinki procedures: 
68 ongoing, 11 
published, 2 abandoned, 
and 9 non-majority 
under MDR/IVDR (EC) 
• 75% of procedures are 
on qualification, while 
25% on classification 
(EC) 
• The average duration 
of a Helsinki procedure 
is 347 days (EC) 

• use of EU-level 
procedures 

-  
(some negative 
impact) 

To what extent have the 
Regulations improved 
transparency for 

• number of CE-marked 
devices 
• number of reports 
published 

• 600.000+ UDIs 
registered in 
EUDAMED in Q1 2025 
(EUDAMED) 

• 27.9% of respondents 
cited the need for 
improved transparency in 
EUDAMED (CfE) 

-  
(some negative 
impact) 

• Although the gradual 
rollout of EUDAMED 
is progressing, until its 
full operationality, 

124 

 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

stakeholders (e.g. 
EUDAMED, SSCPs)? 

• number of published DA 
Summary Reports 

• 75.000+ users 
registered in 
EUDAMED in Q1 2025 
(EUDAMED) 
• 1300+ certificates 
registered in 
EUDAMED in Q1 2025 
(EUDAMED) 
• 2800+ clinical 
investigation reports and 
summaries reported, out 
of which 957 (33%) are 
published (EO survey) 
• 4400+ performance 
studies reports and 
summaries reported, out 
of which 21 (0.5%) are 
published (EO survey) 
• 3400+ summaries of 
clinical safety and 

• There is an emphasize 
need for transparency in 
MDR, particularly 
through the 
implementation of the 
EUDAMED database, 
public access to safety 
and performance data, and 
measures like UDI. 
Recurring themes include 
the importance of 
transparency for trust, 
traceability, and informed 
decision-making, as well 
as critiques of delays in 
EUDAMED’s 
implementation and the 
lack of transparency in 
Notified Body processes, 

125 

Comments / data gaps 

centralised device data 
on the Union market 
remains incomplete. 
This stems primarily 
from the gradual 
implementation process 
rather than the design of 
the regulatory 
framework. 

• Quantitative evidence 
is difficult to rely on 
and observations are 
mostly informed by 
qualitative evidence.   

• Limited SSCPs 
available to date. It is 
difficult to tell if low 
publication rates by 

 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

clinical evidence, and 
certification costs (PP) 

performance (SSCPs) 
reported, out of which 
927 (27%) are published 
(EO survey) 
• 1500+ summaries of 
safety and performance 
(SSPs) reported, out of 
which 197 (12.6%) are 
published (EO survey) 
• 18/20 countries that 
have MDR NBs 
designated have 
published their 
monitoring & on-site 
assessment activity 
reports in 2024 (MS 
annual reports) 
• 7/11 countries that 
have IVDR NBs 
designated have 

126 

Comments / data gaps 

manufacturers is due to 
the absence of 
Eudamed module. 

• It is not possible to 
predict whether the full 
availability of 
EUDAMED will result 
in 100% transparency 
of all information that 
some stakeholders 
request. 

• Availability of 
information does not 
always translate to 
awareness on it. It is 
unclear whether 
awareness of available 
information will 

 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

published their 
monitoring & on-site 
assessment activity 
reports (MS annual 
reports) 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

increase for healthcare 
professionals, patients 
and users. 

• perceptions of 
stakeholders on 
transparency 

/ 

• 74.7% of respondents 
disagree or strongly 
disagree that “robust, 
transparent, predictable 
and sustainable regulatory 
framework exists” (PC) 

• 52% of respondents 
disagree or strongly 
disagree that the MDR 
and IVDR have 
contributed to achieving 
transparency of 
information on devices in 
the EU (PC) 

127 

- 
(negative impact) 

 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

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

• perceptions of 
stakeholders on trust 

/ 

• 55% of respondents 
disagree or strongly 
disagree that the MDR 
has contributed to 
achieving trust in the 
regulatory 
system, while 54% 
believe the same for 
IVDR (PC) 

• For both MD and IVD, 
EOs are more negative on 
whether the 
Regulations have 
contributed to achieving 
trust in the system, while 
NB are more positive 
compared to other 
stakeholders on 

128 

Overall 
assessment 
(scale --/-
/0/+/++) 

--  
(strong negative 
impact) 

Comments / data gaps 

• There 
is no quantitative data 
available on the level of 
trust. 

• Qualitative data, albeit 
from limited sources, 
does reveal important 
barriers to trust. 

• There is no data on 
the level of trust in the 
system before 
the introduction of the 
Regulations, therefore 
the evolution is hard to 
assess. 

• No major 
safety crises with 
MD/IVD have occurred 

 
 
 
Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

since the introduction 
of the Regulations. 

Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

achievement of trust in 
the system (PC) 

• 48.2% of 
respondents shared the 
perspective of the erosion 
of trust in the 
regulatory framework, 
with 20% respondents 
mentioning trust in 
relation to transparency, 
safety, and 
accountability (CfE) 

• At the same time, 
academics, healthcare 
professionals, insurers, 
and manufacturers agree 
that transparency and 
rigorous safety standards 
enhance trust in medical 

129 

 
 
 
Evaluation question 

Indicator(s) 

Quantitative evidence  Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

devices and regulatory 
frameworks. Similarly, 
PMS and patient 
engagement are seen as 
trust-building 
measures (PP) 

130 

 
 
 
 
 
 
 
 
Table 2: Scoring of notified bodies, conformity assessment procedures and clinical evidence 

Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

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

•  Context of 

notified bodies 

•  Level of 

harmonisation in 
designation of 
NBs 

•  Level of 

harmonisation in 
monitoring of 
notified bodies 
by designating 
authorities 

•  Level of 

coordination 

•  Gradual increase of 

NBs over time - Total 
of 51 MDR & 18 IVDR 
(EC). 

•  12 MDR & 6 IVDR 
applications for 
designation ongoing 
(EC). 

•  13 applications 

withdrawn (9 MDR & 4 
IVDR) 4 from the UK 
and 1 from CH. 
•  Designation of NBs 
takes an average of 
1041 days (median: 
1022 days) for MDR 
and 1166 days (median: 
1296 days) for IVDR. 

•  Stakeholders outlined criticism of 
capacity shortages in terms of 
number of NBs designated [now a 
solved issue for MDs] and 
availability for review under 
specific codes, inconsistent 
interpretations of regulations, and 
delays in certification processes 
and lack of harmonisation (PP). 

•  112 entries (40.7%) featured 

capacity constraints of NBs (CfE). 

•  Class B and C IVDs now require 
NB involvement. Increased 
demand for IVDR notified bodies 
compared to IVDD. 

•  There has been no change in 

monitoring structures between the 

131 

Overall 
assessment 

(scale --/-
/0/+/++) 

- 

(negative) 

Comments / data gaps 

•  Strong bottleneck on NB 
capacity at the beginning. 
Resolved now for MDR. 

•  Code coverage is not 
evenly spread. Whilst 
most codes applied are 
obtained, highly 
specialised codes have 
low coverage. 

•  Scope extensions require 
following the whole 
designation process. 

•  Most designation NCs are 
in process and resource 
requirements. Significant 
variation between 
Member States. 

 
 
 
Overall 
assessment 

(scale --/-
/0/+/++) 

Comments / data gaps 

•  The number of NBs in a 

country does not correlate 
with the number of 
national experts dedicated 
to JAT process. 

•  NBs and DAs, and their 

activities, are not 
sufficiently coordinated 
nor harmonised. This 
impacts the smooth 
functioning of the internal 
market. 

Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Positive evolution. 
Latest body to apply 
and get designated took 
745 days for MDR and 
686 days for IVDR 
(EC). 

•  Longest steps in 

designation process: on-
site assessment to 
CAPA (245 days for 
MDR and 194 days for 
IVDR) and CAPA JAT 
opinion to national 
DA’s final report (197 
days for MDR and 134 
days for IVDR)(EC). 

•  92% MDR and 97% 

IVDR of codes applied 

Directives and the Regulations. 
Key monitoring activities are 
performed by national authorities 
independently without central 
oversight (the only information 
shared is via the national DA 
annual report). 

•  Calls for harmonised practices, 
improved transparency, and 
streamlined oversight mechanisms 
of notified bodies. Frequently 
mentioned solutions include 
harmonised oversight, centralised 
governance, and improved 
coordination to ensure consistency 
and efficiency. Proposals for 
centralizing governance to oversee 
Notified Bodies are suggested 
(PP). 

132 

 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 

(scale --/-
/0/+/++) 

Comments / data gaps 

for by NBs were 
obtained. 

•  3 out of 9 requests for 
scope extensions under 
the Regulations to date 
already completed. 

•  21 NBO and 12 NBCG-
Med meetings; 29 
MDCG-endorsed 
documents and 3 
NBCG-Med documents 
(EC). 

•  275 entries to the CfE discussed 
challenges with the NB system 
under the Regulations. Recurring 
themes included limited capacity, 
long delays, inconsistent 
interpretations of regulations, high 
costs, and lack of harmonisation 
across NBs (CfE). 

•  88 entries (32.0%) discussed the 
need for harmonisation and 
oversight with calls for centralised 
governance, standardised 
processes, and improved 
coordination (CfE). 

To what extent 
are conformity 
assessments 
carried out 
effectively, 

•  Quality of 
conformity 
assessments 

•  Level of 

predictability of 

•  The number of NB 

FTEs has continuously 
increased. >1,500 of 
NB FTEs (>30%) are 
dedicated to 

•  NBs indicate that most of the 

applications they receive are of 
low quality and incomplete (NB 
survey). 

-- 

(strong 
negative) 

•  Lack of information on 
certification demand. 
Unknown what would 
constitute ‘sufficient’ 
resources. 

133 

 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 

(scale --/-
/0/+/++) 

predictably and 
consistently? 

conformity 
assessment 

• 

administrative and 
supporting tasks (NB 
survey). 

Issuance of a new 
certificate takes 6-18 
months (QMS only) 
and 13-24 months 
(QMS and product) 
(NB survey). 

•  Most refusals of certification 

applications are due to ‘outside 
scope of notified body’s 
designation’ (631/1,149 or 
54.9%), ‘application not complete’ 
(179/1,149 or 15.6%), and ‘wrong 
qualification of 
product/classification of device’ 
(148/1,149 or 12.9%) (NB 
survey). 

•  Half of the total time to 
achieve certification is 
spent with the 
manufacturer (EO and 
NB survey). 

•  The estimated reduction 

in length of the 
conformity assessment 
was <25% or no 
reduction at all for the 

•  Manufacturers disagree that 

conformity assessment activities 
of NBs are harmonised (PC). 

•  Respondents are more likely to 

disagree that conformity 
assessment activities of notified 
bodies are harmonised for the 
Regulations compared to the 
Directives (PC). 

134 

Comments / data gaps 

•  High dissatisfaction with 
predictability of NB 
processes (CfE, PP, 
workshop). 

• 

Inefficiencies, delays, and 
lengthy, inflexible and 
unpredictable processes 
are often cited as causes of 
delays and high costs 
(CfE). 

•  Manufacturers and 

industry associations 
emphasised reducing 
administrative burdens 
and introducing fast-track 
pathways, while 
healthcare professionals 
and insurers stressed 
maintaining robust safety 

 
 
 
Overall 
assessment 

(scale --/-
/0/+/++) 

Comments / data gaps 

standards and streamlined 
assessments for orphan 
devices (PP). 

Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

majority of experiences 
of structured dialogue 
(NB survey). 

•  <50% stakeholders agreed MDR 

contributed to a level playing field 
in assessments, and that 
conformity assessments were 
predictable in duration (PC). 

•  Stakeholders criticised 

inefficiencies, delays, and lengthy, 
inflexible and unpredictable 
processes resulting in knock-on 
delays and high costs, particularly 
for SMEs, orphan devices, and 
low-risk products.  Recurring 
themes raised included 
inefficiency, complexity, and 
unpredictability (PP). 

•  Calls for streamlined processes, 
binding timelines, harmonised 
methodologies, and reduced 
duplication are prevalent (PP). 

135 

 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 

(scale --/-
/0/+/++) 

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

•  Level/Quality of 
clinical data 
available for 
assessment 

•  Level of access 
to external 
scientific and 
clinical expertise 
in regulatory 
process 

•  Average cost of clinical 
evaluation is EUR 
105,654.37 (lowest for 
class Ir MDR: EUR 
27,764; highest for 
class III MDR: EUR 
246,609) (EO survey). 

•  The number of CI 
applications has 
remained stable, with 
the proportion of 
granted (~85%) versus 
denied (~15%) also 
remaining stable (NCA 
survey). 

•  The number of PS 
applications has 
increased (NCA 
survey). 

•  New structures for scientific 
advice have been established. 

•  71.2% NBs reported that over >½ 
of CERs/PERs are incomplete or 
inaccurate, with >50% indicating 
that >¾ of the CERs/PERs are 
incomplete or inaccurate (NB 
survey). 

0/+ 

•  CI/PS reports and their summaries 
are not being made public (<10% 
for MDs and <0.5% for IVDs). 

(mixed with 
some 
positive) 

•  51.1% (or 23/45) notified bodies 
indicated that less than half of 
manufacturers carry out the 
foreseen activities in compliance 
with their PMCF plan for class III 
and implantable medical devices 
(NB survey). 

136 

Comments / data gaps 

•  R&D continues to occur. 

•  Regulatory advice is cited 
as a potential aid to the 
system. 

•  A central structure for 
coordination of multi-
national clinical 
investigations is cited as a 
potential aid to the system 
(RC workshop). 

•  There is significant 

variation in the number of 
applications to conduct 
clinical investigations that 
countries receive. 

•  Whilst data gathering has 
increased, NBs report that 
evaluations are incomplete 

 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

•  The number of PMCFs 
remains low, but has 
steadily increased 
(NCA survey). 

•  CIs for research 

purposes have increased 
(NCA survey). 

•  77 CECP/PECP 

submissions to expert 
panels in 2024 alone, 
and 31 opinions issued 
since their inception 
(EMA) 

•  Expert panels 2025: 32 
opinions on NB’s clinical 
assessment of high-risk 
medical devices (CECP), 
21 views on the 
performance evaluation of 

•  43.8% (or 14/32) of HCPs agree or 
strongly agree that there is more 
clinical data available on medical 
devices today compared to in 
2017, and 40.6% (or 13/32) that it 
is of better quality (PC). 

•  Stakeholders perceive that clinical 
evidence, and its availability have 
increased (RC workshop). 

•  Early dialogue is seen as key for 
planning and developing CIs that 
will bring useful clinical evidence 
(RC workshop). 

•  211 entries to the CfE referenced 
requirements for robust clinical 
evidence. The disproportionate 
requirements for clinical evidence 
were discussed by 78 entries 

137 

Overall 
assessment 

(scale --/-
/0/+/++) 

Comments / data gaps 

and HCPs/users that is not 
available. 

•  Some data collected (e.g. 

perceptions re 
proportionality of 
requirements for low and 
medium risk devices) is 

 
 
 
 
 
 
 
 
 
 
 
 
Overall 
assessment 

(scale --/-
/0/+/++) 

Comments / data gaps 

more appropriate for and 
has been used in section 
4.1.2 ‘Efficiency’ of the 
SWD or section 4.2. 
‘Relevance’ (e.g. re 
proportionality of 
requirements for niche and 
orphan devices) 

Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

class D IVDs (PECP) 
(EMA) 

(36.7%), particularly in relation to 
low-risk and legacy devices (CfE). 

•  53.2% (or 25/47) 
notified bodies 
indicated that more than 
75% of CERs/CERs are 
incomplete or 
inaccurate. 72.3% (or 
34/47) indicate that 
more than half are 
incomplete or 
inaccurate (NB survey). 

•  Challenges for SMEs and startups 
were highlighted by 52 entries 
(24.6%), with the excessive 
burden resulting in high costs, 
delays, and resource (CfE). 

•  49 feedback entries (23.2%) 

maintain that legacy devices with 
proven safety and performance 
should not require duplicative or 
new clinical evidence (CfE). 

•  Patient organisations highlighted 
challenges in meeting clinical 
evidence requirements for rare 
diseases, while an NGO called for 
greater representation of 
unrepresented groups (e.g. women, 

138 

 
 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 

(scale --/-
/0/+/++) 

Comments / data gaps 

children) in clinical investigations 
(PP). 

•  Manufacturers advocated for 

streamlined processes and real-
world evidence, whereas 
regulators and insurers stressed 
maintaining high standards (PP). 

139 

 
 
 
 
 
Table 3: Scoring of market functioning and even playing field 

Evaluation question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

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

• number of patents 
• scientific advice 
provided by expert 
panels 
• number of devices on 
Union market (as 
registered in 
EUDAMED to date) 

• 21168 devices under IVDD 
registered in EUDAMED 
• 206179 devices registered 
under MDRR in EUDAMED 
• 34661 devices registered 
under IVDR in EUDAMED 
• 511086 devices registered 
under MDR in EUDAMED 
(EC, July 2025) 
• number of patent 
applications increased by 
19% between 2017 and 2024 
(EPO) 
• patents granted increased by 
29.5% between 2017 and 
2024 (EPO) 
• Expert panels 2024: the 
number of CECPs grew with 

140 

Overall 
assessment 
(scale --/-
/0/+/++) 

0/+ (mixed to 
some positive) 

Comments/data gaps 

• In 2024, whilst the highest 
number of granted patents 
originated from the US, the 
EU was in the 2nd place, 
with nearly 40% fewer 
patents than the US (EPO). 

• The number of patents 
granted in Europe increased 
between 2009 and 2020, 
experienced a decline in 
2021 coinciding with the 
implementation of the 
MDR, but recovered by 
2024 (EPO). 

• Number of devices and 
new devices on market 
cannot accurately be 

 
 
 
 
  
approx. 720% between 2021 
and 2024 (EMA report) 
• 6 published scientific advice 
by expert panels (on MDCG 
request) for medical device 
and IVDs (EMA website) 

• international 
participation 

• EU is active in 7 out of 8 
active IMDRF WGs (IMDRF 
website) 
• 8 MS have in total 15 
experts participating in these 
WGs (IMDRF website) 
• 1,434 MDR and 180 IVDR 
certificates have been issues 
on the basis of the 
MDSAP/MDR-IVDR 
combined audit (NB survey) 
• EU is aligned with 84% of 
the IMDRF guidance 
(IMDRF) 
• about 85% of the 326 
harmonised standards 

• participation in global 
governance efforts (e.g. 
IMDRF, MDSAP) is 
encouraged and supported to 
enhance market access and 
reduce trade barriers 
(Webinar on the targeted 
evaluation MDR/IVDR:  
International Partners May 
2025, including , 
Switzerland, the UK, and 
Australia), there is need for 
improved communication 
and better alignment with 
international partners, as 
well as better 

141 

0/+ (mixed to 
some positive) 

determined in the absence 
of fully functional and 
mandatory EUDAMED. 
Even with limited data in 
EUDAMED so far due to 
voluntary registrations, 
trend analysis is not 
possible.  

• Since 2017, there are 
fewer operational bi-lateral 
international agreements 
(e.g. mutual recognition 
agreements) than under 
Directives. However, this 
can be influenced by other 
factors (e.g. trade and 
political developments) than 
the regulatory framework.   

• EU’s involvement in 
IMDRF WGs has increased 
in 2024/2025 after 
decreasing for a number of 
years due to focus on 

 
 
 
  
 
communication on safety 
issues and broader 
EUDAMED access.  

requested by the Commission 
from CEN and CENELEC to 
support MDR/IVDR are 
based on international 
standards from ISO and IEC 
(eNorm Platform) 
• 26 of the 38 MDR/IVDR 
harmonised standards 
published in the OJEU are 
based on ISO/IEC standards 
(eNorm Platform) and 12 are 
purely European standards.  

• European MD market 
• European IVD 
market 

• the European medtech 
market is estimated at €170 
billion in 2024, making it the 
world’s second largest with 
26.4% of global share, 
compared to the US (46.4%), 
China (6.5%), and Japan 
(4.7%) (MTE report) 
• there are more than 38,000 
medical technology 
companies in Europe, out of 

• the main trade partners for 
medical devices in Europe 
are the US, China, Japan, 
and Mexico (MTE report) 
• the challenges in the 
innovation climate have 
intensified by 2025, 
significantly affecting SMEs 
and start-ups as reported by 
stakeholders (CfE, PP) 

0/+ (mixed to 
some positive) 

142 

MDR/IVDR 
implementation. 

• Available EU harmonised 
standards are mostly based 
on with international 
standards. 

• Measures of how EU 
remains competitive on 
international stage are 
difficult to interpret with 
data available. 

• Compared to 2017, the 
overall market is larger and 
more resilient, with long-
term average annual growth 
(market expansion and 
rising demands however not 
in terms of number of 
devices, as this is not 
measurable). 

• Data on this topic remains 
limited, as findings rely 

 
 
 
 
which 90% are SMEs (MTE 
report) 
• there are more than 930,000 
employees in the medical 
technology industry (MTE 
report) 
• the European MD market 
has been growing on average 
by 6.0% per year over the 
past 10 years (MTE report) 
• the annual growth rate for 
MD has varied between 2.4% 
(2017) and 9.3% (2015) 
(MTE report) 
• the European IVD market 
has been growing 4.3% on 
average, hitting the record 
40% in 2021 (MTE report) 
• Europe has a positive 
medical devices trade balance 
of €5 billion in 2024 (MTE 
report) 

143 

primarily on a single source 
(MedTech Europe facts & 
figures 2025 i.e. MTE 
Report). 

• The growth in the market 
based on manufacturer 
prices does not indicate 
proportional increase in 
innovation or 
competitiveness, as the 
growth rates rather indicate 
market expansion or rising 
demands. 

• The EU has maintained a 
strong export position, but 
more companies report 
shifting innovation and 
market entry to other 
regions – particularly the 
US – due to regulatory 
predictability and speed 
(CfE, PP). 

 
 
 
• perceptions of 
stakeholders on 
innovation and 
competitiveness 

• 31% of respondents in the 
governance study totally 
disagree and 29% somewhat 
disagree that the EU 
MDR/IVDR frameworks 
support the placing on the 
Union market of highly 
innovative devices 
• 60% of respondents in the 
governance study believe that 
MDR does not stimulate at all 
the introduction of highly 
innovative devices on the 
Union market, while 48% 
believe this for IVDR 
• 65% of stakeholders 
strongly disagree that the 
MDR contributed to 
innovation in the medical 
device sector in the EU (PC) 
• 41% of stakeholders 
disagree, while 33% strongly 
disagree that the MDR 
contributed to the 
competitiveness of the 

144 

• stakeholders from the 
governance study are 
sceptical regarding the 
adaptability of the 
MDR/IVDR to support 
technological innovation in 
the sector over the next 5-10 
years 
• the key regulatory barriers 
for the industry to bring 
innovative devices to the 
Union market are 
considered to be the 
administrative burden and 
costs of regulatory approval, 
followed by the length of 
the certification and 
recertification process (CfE, 
PP) 

-- (strong 
negative 
impact) 

• Data collected through 
multiple sources reveals 
broad consensus across 
stakeholders that the EU’s 
MDR/IVDR regulatory 
frameworks hinder 
innovation, particularly for 
SMEs, start-ups, and niche 
markets. Common concerns 
include high costs, 
administrative burdens, 
lengthy approval processes, 
and regulatory 
unpredictability, which 
divert resources from R&D 
and delay market access 
(CfE, PP, PC, governance 
study) 

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

• single-use devices 
• n. of certificates 
issued by notified 
bodies for 
relabelling/repackaging 
activities 

medical device sector in the 
EU (PC) 

• 17/30 countries prohibit the 
use of reprocessing of single 
use devices (study on the 
implementation of Article 17 
MDR) 
• 10/30 allow the use of 
reprocessing of single use 
devices (study on the 
implementation of Article 17 
MDR) 
• 3/30 did not take a decision 
(study on the implementation 
of Article 17 MDR) 
• 6/38 surveyed NBs certify 
single use devices or 
reprocessing single use 
devices (report on the 
operation of Article 17 MDR) 
• 24 certificates for quality 
management systems issued 
by notified bodies under 
Article 16(4) MDR and 13 

145 

/ 

0 (neutral) 

• Despite efforts to reduce 
fragmentation on the single 
market, approach to the 
regulation of reprocessing 
of single-use devices under 
the MDR Article 17 in MS 
remain disparate 
and the safety & 
performance of these 
devices has not necessarily 
increased. Data is limited 
however and only based on 
one existing study.  

 
 
 
 
• perceptions of 
stakeholders of even 
playing field for 
economic operators 

under IVDR, for re-labelling 
and re-packaging activities by 
importers and distributors 
under Regulations (GOG 
survey) 

• 63.7% of stakeholders state 
that inconsistencies in the 
interpretation, 
implementation, and costs of 
MDR/IVDR Regulations 
across MS and NBs create an 
uneven playing field (CfE) 
• 38.1% highlight that the 
MDR/IVDR 
disproportionately affects 
SMEs compared to larger 
companies, creating 
competitive disadvantages 
(CfE) 

146 

• SMEs are consistently 
highlighted as 
disproportionately burdened 
by high compliance costs 
and limited NB access, 
creating an uneven playing 
field (CfE, PP) 
• Stakeholders share the 
need for harmonised 
regulations, consistent NB 
practices, and reduced 
disparities across MS to 
ensure fairness (CfE, PP) 
• Stakeholders also highlight 
fragmented implementation 
of MDR/IVDR, creating 
regulatory uncertainty and 
competitive disadvantages 
(CfE, PP) 

- (some 
negative 
impact) 

• Data collected through the 
CfE, PP, and PC comes 
with certain limitations as it 
is mostly qualitative. 

• The main causes of the 
uneven playing field for 
economic operators are 
regulatory inconsistencies 
across NB and MS, 
fragmented national 
implementation, and 
disproportionate burdens on 
SMEs. 

 
 
 
To what extent has the 
MDR/IVDR affected the 
availability of devices 
on the Union market 
(shortages, withdrawals, 
delays)? 

• number of devices on 
EU 
market 
• certificates 
• remaining transition 
of devices 

• >2,000,000 medical 
technologies, categorised into 
>7,000 generic devices 
groups (WHO) 
• 10,554 MDR certificates by 
Annex until October 2024 
(GOG survey) 
• 1,273 IVDR certificates by 
Annex until October 2024 
(GOG survey) 
• 28% of NB indicated that 
less than 25% of their clients 
with certificates under the 
Directives have completed 
the transfer to MDR of all 
devices intended to be 
certificated (GOG survey) 
• 28% indicated that between 
76 and 99% of their clients 
with certificates under the 
Directives have completed 
the transfer to MDR of all 
devices intended to be 
certificated (GOG survey) 

/ 

147 

0/- (mixed to 
some negative) 

• Limitation is that 
quantitative data available 
is limited due to on-going 
implementation and tools 
e.g. EUDAMED not yet 
available to fully capture. 

• Scoring is therefore based 
also largely on qualitative 
data. 

• GOG monitoring survey 
has been going since April 
2023 (1st NB survey) to 
April 2025 (14th NB 
survey). 

• Accurately determining 
the number of medical 
devices currently available 
on the Union market 
remains is not yet possible. 
lack of reliable baseline 
data makes it challenging to 
estimate what proportion of 

 
 
 
• 46% of NB indicated that 
less than 25% of their clients 
with certificates under the 
Directive have completed the 
transfer to IVDR of all 
devices intended to be 
certificated (GOG survey) 
• 15% of NB indicated that > 
50% of their clients have 
completed the transfer (GOG 
survey) 

• almost 60% of HCP/HCP 
associations reported that in 
the last 3 years they 
experienced problems 
purchasing/being supplied 
with relevant devices – MD 
(PC) 
• 43% HCP/HCP associations 
and 65% of the health 
institutions reported the same 
for IVD (PC) 
• 393 stakeholders highlight 
concerns about reduced 

148 

• potential shortages 
• stakeholders’ 
perceptions on 
shortages 

devices may not transition 
to the Regulations.  

• Key reasons for 
discontinuing devices from 
the market include low 
revenue, low sales volume, 
replacing the products, and 
life cycle, based on the EO 
survey. Position paper 
emphasises certification 
delays, high compliance 
costs, and bureaucracy. 

• Both the number of 
applications and the number 
of certificates has 
constantly increased since 
the introduction of the 
Regulations. 

• Stakeholder perceptions 
on availability vary 
depending on the group, 
with manufacturers most 

• 70% of surveyed 
stakeholders referenced 
market withdrawal of 
devices due to high 
compliance costs, lengthy 
certification processes, and 
limited NB capacity 
• 61% of European hospital 
pharmacists responded to a 
survey that medical devices 
shortages are a problem in 
their hospital 

- (some 
negative 
impact) 

 
 
 
availability of medical 
devices due to stringent MDR 
and IVDR regulations (CfE) 
Since early 2025, circa 40 
Article 10a notifications for 
discontinuation/interruption 
have been received, a third of 
them affecting devices with 
no alternatives (EC, internal 
sources). 

• General consensus 
amongst stakeholders that 
introduction of Regulations 
has caused problems with 
the availability of devices in 
the EU (CfE, PP) 
• Economic operators were 
the least likely to agree that 
the Regulations contribute 
to the availability of devices 
on the EU, whereas citizens 
and patient associations 
were the most likely to 
agree (PC) 

• over 52% of MD 
respondents that produce 
orphan devices indicate they 
will transfer all their orphan 
devices to the MDR and 29% 
report they do not plan to 
transfer any (MTE 2024 
report) 
• 26.6% of IVD 
manufacturers reported they 

• 47% of respondents 
somewhat or totally 
disagreed that the MDR 
supports the placing on the 
Union market of orphan 
devices versus 14% who 
somewhat or totally agreed 
(governance study) 
• The perceived limited 
adaptability of the 

149 

likely to indicate problems 
with availability and 
citizens and patient 
associations least likely to 
indicate problems with 
availability. 

• A total of 138 MD and 73 
IVD manufacturer 
organisations participated in 
the MTE 2024 survey, with 
an almost equal distribution 
between large companies 
and SMEs. 

• Orphan devices are seen 
as critical to deliver 
essential therapy to patients 
with little alternatives. 
However, many 
manufacturers indicate their 
discontinuation of these 
devices. 

• orphan devices 

 
 
 
  
will transition less than 5% of 
their portfolio of orphan 
devices (MTE 2024 report) 

regulatory framework to 
orphan devices was often 
linked to the difficulties 
with obtaining the required 
clinical evidence for these 
device (governance study) 
• NCAs considered that 
there are difficulties in 
predicting the availability of 
orphan devices for patients 
and end users (governance 
study) 

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

• number of health 
institutions 
• number of in-house 
devices 
• number of 
derogations 

• 30,776 health institutions 
reported by 13 CA who 
responded to the NCA survey 
• 79 health institutions having 
notified IH MDs in 10 CAs 
(NCA survey) 
• 67 health institutions having 
notified IH IVDs in 10 CAs 
(NCA survey) 
• In a BioMed Alliance 
survey, the labs which 
participated indicated they 

• 46% of respondents agree 
that the MDR contributed to 
protecting the health of 
patients in relation to 
medical devices, while 44% 
believe the same for IVD 
(PC) 
• 40% of respondents agree 
that MDR contributed to 
protecting the health of 
users in relation to medical 

150 

0/- (mixed to 
some negative) 

• Although the Regulations 
are designed to address 
specific needs of patient and 
target groups, 
implementation challenges 
often prevent these needs 
from being effectively met, 
particularly in the case of 
in-house devices. 

• Limited to no data was 
collected for in-house 
devices, which limits the 

 
 
 
had 52% CE-IVDs, 14% 
modified/off-label CE-IVDs, 
8% RUOs, and 26% IH-IVDs 
• 10 national derogations for 
“compassionate use” (MD) 
started before 2017 and 48 
started after 2017 (EC) 
• 750 national derogations 
granted for Art 59(2) MDR 
and 49 for Art 54(2) IVDR 
(EC) 

151 

devices, while 35% believe 
the same for IVD (PC) 

analysis and conclusions for 
this topic. 

• While data on 
compassionate use is not 
collected, the MDR 
captures national notified 
derogations, which 
increased during COVID 
and then stabilised, with 
significantly fewer 
notifications for IVDs 
compared to MDs. 

• EU-wide derogation 
mechanism has been used 
only once, with 
stakeholders pointing to 
burdensome procedures as a 
likely reason for its limited 
uptake. 

• Stakeholders call for 
clearer definitions and 
regulatory frameworks, 
emphasising the need for 

 
 
 
flexibility to accommodate 
innovation and the unique 
needs of in-house devices. 

• Healthcare professionals 
and institutions report that 
regulatory requirements are 
unclear and burdensome, 
significantly impacting the 
development of in-house 
devices. 

152 

 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1: Europe in the world of medical device market based on manufacturer prices (MTE facts and figures 2025) 

153 

 
 
 
 
 
 
 
 
Figure 2: European medical device market growth rates based on manufacturer prices (MTE facts and figures 2025) 

154 

 
 
 
 
 
 
 
 
 
 
Figure 3: European IVD market growth rates based on manufacturer prices (MTE facts and figures 2025) 

155 

 
 
 
 
 
 
 
 
Table 4: Scoring of post-market surveillance, vigilance and market surveillance 

Evaluation 
question 

How successful 
have the MDR 
and IVDR been 
in contributing 
to its general 
objectives in 
terms of: 

(a) ensuring a 
high level of 
protection of 
health for 
patients and 
users? 

To what extent 
has post-
market 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

•  Level of vigilance 
activities and 
harmonisation of 
approaches for 
manufacturer 
corrective actions 
across Member 
States 

•  Level of vigilance 
activities by 
manufacturers 

•  Level of market 
surveillance 
activities by 
Member States 

•  Post-market surveillance 
and vigilance activities 
have increased (>20% in 
MIRs, >30% in PSRs, 
and >1% in FSCAs, from 
2017-2024) (NCA 
survey). 

•  15.3% (or 26/170) 

manufacturers indicated 
that the number of MIRs 
they submit has 
increased, and 23.5% (or 
40/170) indicated that at 
least one MIR had led to 
a FSCA (PC). 

•  13.5% (or 23/170) 

manufacturers indicated 
that they had submitted 

•  >¾ (or 13/17) EU/non-EU 
citizens agree or strongly 
agree that devices are 
sufficiently monitored 
(0/17 disagree or strongly 
disagree), and almost ¾ (or 
261/352) of stakeholders 
agree or strongly agree that 
safety issues are 
adequately identified and 
addressed when detected 
(PC). 

•  46.9% (or 15/32) 

healthcare providers 
agreed or strongly agreed 
that they were aware on 
how to report an incident 
with MDs, and 0% (0/14) 

Overall 
assessment 
(scale --/-
/0/+/++) 

+ 

(positive) 

Comments / data gaps 

•  Only 16 EU MS + 1 
EAA + 1 Customs 
Union country 
(18/30) responded to 
the NCA survey. 

•  Most devices on the 
market are still 
legacy devices, yet 
there’s an increase in 
reports of serious 
incidents. Difficult to 
assess whether any 
evolution observed 
reflects changes in 
device safety or 
reportability. 

•  Duplication and 
overlapping of 

156 

 
 
 
 
Evaluation 
question 

surveillance 
and vigilance 
improved the 
detection and 
management of 
risks? 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

MIRs that, after further 
analysis, did not fulfil the 
vigilance reporting 
requirements (PC). 

•  >8-fold increase in 
product samples 
controlled (NCA survey). 

•  >25% increase in CEFs 

(NCA survey). 

• 

Inspections remain 
constant. However, <¼ of 
national inspection 
reports have a 
corresponding final 
inspection report (NCA 
survey). 

agreed or strongly agreed 
with IVDs (PC). 6.5% (or 
3/46) agreed or strongly 
agreed that they are 
reporting more safety 
issues now compared to 
2017. 

•  130 entries to the CfE 

presented perspectives on 
PMS. Recurring themes 
included critiques of the 
excessive administrative 
burden, redundancy, and 
inefficiency of PMS 
requirements (CfE). 

•  21.5% of entries to CfE 
indicated that PMS 
requirements were overly 
burdensome and 

157 

Comments / data gaps 

reporting 
requirements and of 
assessment. 

•  Coordination of NCA 
vigilance and market 
surveillance 
activities, and joint 
actions, are 
increasing. 

•  Experience with 

market surveillance 
measures is starting. 

•  EUDAMED’s 

Market  Surveillance 
module  will  only  be 
and 
available 
mandatory 
to  use 
from  28  May  2026, 
and 
the  vigilance 
module will follow.   

 
 
 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

disproportionate. 
Criticisms included 
excessive documentation, 
redundant reporting, and 
disproportionate 
requirements for low-risk 
or well-established devices 
(CfE). 

•  22 (16.9%) entries argued 
for a risk-based approach, 
with proposals including 
tailoring PMS to device 
risk class, market history, 
or safety profile (CfE). 

•  12 (9.3%) entries 

highlighted the need for 
petter integration of PMS 
with other regulatory 
processes (CfE). 

158 

 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

•  There is broad support for 
leveraging real-world data, 
streamlining reporting, and 
adopting risk-based 
approaches to reduce 
administrative burden 
(CfE). 

•  Mixed perceptions on the 

legal clarity in post-market 
surveillance (32.9% agree 
or strongly agree, and 
42.3% disagree or strongly 
disagree) and on the value 
of MCDG guidance 
documents (57.3% agree 
or strongly agree, and 
45.8% disagree or strongly 
disagree) (PC). 

159 

 
 
 
Evaluation 
question 

Indicator(s) 

Quantitative evidence 

Qualitative evidence 

Overall 
assessment 
(scale --/-
/0/+/++) 

Comments / data gaps 

•  149 vigilance coordination 
exchanges since 2021 
among NCAs. 

•  3 market surveillance 

device safety task forces 
since 2021. 

•  21 Member States 

participate in JAMS 2.0, 
and 9 Member States 
participate in JACOP. 

•  Most NCAs conduct 
market surveillance 
activities for devices 
offered by distance or 
online sales (66.6% or 
12/18) (NCA survey). 

160 

 
 
 
 
Table 5: Scoring of Simplification and streamlined procedures 

Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

Regulatory  structure  and 
coordination 

•  Governance  and 
ways of working  

• Resources 

• 275 responses to the Call for Evidence discuss 
challenges  with  the  notified  body  system  under 
included 
the  Regulations.  Recurring 
limited  capacity, 
inconsistent 
interpretations of regulations, high costs, and lack 
of harmonisation across notified bodies (CfE). 

long  delays, 

themes 

• 95 entries (34.5%) discussed problems related to 
inconsistencies  in  notified  body  practices  were 
raised. 
in 
included 
interpretations, timelines, costs, and requirements 
across notified bodies (CfE). 

variability 

These 

•  88  entries  (32.0%)  discussed  the  need  for 
centralised  governance,  standardised  processes, 
and improved coordination (CfE). 

• Two notified bodies provided feedback calling 
for  clearer  guidance  and  streamlined  processes 
(CfE). 

• One notified body acknowledged proposals for a 
single  governance  structure  for  notified  body 

161 

- 

(negative) 

•  Data from the CfE and 
PP is in the form of 
open contributions. 
The study on 
governance was the 
only structured data 
collection exercise on 
this topic. 

•  Governance is a 

perception-based topic 

•  Lack of quantitative 
data due to difficulty 
to measure. 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

designation  and  monitoring  but  warned  that  it 
could  reduce  competitiveness  and  increase  costs 
while potentially impacting patient safety (CfE). 

• One survey found that only 6% of all companies 
working  with  notified  bodies  have  no  problems 
working with the notified body in question (PP). 

•  Three  manufacturer  associations  propose 
centralising  notified  body  designation,  among 
other tasks (PP). 

•  One  manufacturer  association  also  cites 
'[i]nconsistent  demands  being  placed  on  the 
notified  bodies  from  each  individual  competent 
authority' (PP). 

•  One  position  paper  stated  that  'Manufacturers 
experience  a  fragmented  approach  during  the 
review  of  Technical  Documentation  and  audits, 
resulting  in  inconsistencies  in  the  assessment  of 
conformity and compliance’ (PP). 

•  A  health  provider  suggested  that  ‘enhanced 
harmonisation  and  centralisation,  would  also 

162 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

indirectly  contribute  to  enhancing  predictability 
for  manufacturers  and  researchers  alike  and, 
thereby, fostering innovation.’ (PP). 

• Of the respondents to the NCA survey (16 EU 
MS,  1  EEA,  1  Customs  Union  country),  there 
were  a  total  of  58  FTEs  dedicated  to  EU-level 
coordination (NCA survey). 

• 28% of 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 (governance study). 

• 32% of healthcare institutions, professionals or 
patient  organisations,  and  34%  of  economic 
that 
operators  or 
collaboration  among  actors  is  good  (governance 
study). 

trade  associations,  agreed 

• 33% of both national competent authorities and 
economic  operators  or  trade  associations,  and 
36%  of  healthcare  institutions,  professionals  or 

163 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

Predictability and 
proportionality 

•  Cost-efficiency of 
body 

notified 
certification 

•  Timelines 

for 

certification 

•  Requirements  for 
and 

low- 
medium-risk 
devices 

•  Well-established 
technologies 

patient organisations, agreed that most issues with 
the  governance  structure  were  temporary  and 
were  likely  to  subside  within  the  following  2-3 
years (governance study). 

•  The  average  cost  of  MDR  recertification  was 
EUR  45,748  for  QMS  certificates  and  EUR 
35,104  for  product  certificates,  as  reported  by 
EOs. 

•  There  are  currently  12  well-established 
technologies.  The  current,  on-going  revision  of 
this  list  has  identified  a  further  >50  potential 
candidates for WET designation. 

•  Average  cost  of  drawing  up  the  clinical 
evaluation  was  EUR  105,654  (lowest:  EUR 
27,764  for  Class  Ir;  highest:  EUR  246,609  for 
Class III). 

• Classification disputes/decisions have decreased 
under the Regulations compared to the Directives. 

• The respondents to the NCA survey (16 EU MS, 
1 EEA, 1 Customs Union country), indicated that 

164 

- 

(negative) 

is 

•  Predictability 

a 
perception-based topic 
•  Lack  of  quantitative 
data due to difficulty to 
measure. 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

they had received 349 consultation procedures for 
tissues  or  cells  of  animal  origin  or 
their 
derivatives; 7 for companion diagnostics (+ 24 to 
the EMA); 2 for substance-based devices; and 623 
for  ancillary  substances  incorporated  in  medical 
devices (+ 9 to the EMA). 

•  Almost  ¼  of  NBs  that  had  used  structured 
dialogues experienced >25% reduction in time for 
conformity assessment (NB survey). 

•  198  entries  (61.1%)  highlight  variability  in 
interpretations  by  notified  bodies  and  national 
authorities, 
and 
to 
leading 
unpredictability (CfE). 

inefficiencies 

112 

entries 

discussed 

• 
the 
(31.1%) 
disproportional  impact  of  the  Regulations  on 
SMEs  and  start-ups.  A  NoBoCap  report  found 
innovation  activities/projects  for  new  devices 
declined with 59% for SMEs active in IVDs and 
54% for SMEs active in MDs (CfE). 

165 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

•  76  entries  (23.9%)  criticise  the  stringent 
requirements  for  low-risk  devices,  suggesting 
they do not align with actual safety risks (CfE). 

•  325  entries  discussed  the  impact  of  the 
Regulations on SMEs, with 85.5% of these entries 
(278  entries)  discussing  the  disproportionate 
financial  and  administrative  burdens  of  the 
Regulations  on  SMEs.  67  entries  (38.1%) 
highlighted 
MDR/IVDR 
disproportionately  affects  SMEs  compared  to 
larger 
competitive 
companies, 
disadvantages (CfE). 

creating 

that 

the 

• 132 entries (33.6%) discuss specific challenges 
for  niche  and  orphan  devices,  with  stakeholders 
highlighting  the  disproportionate  impact  of  the 
Regulations (CfE). 

78 

(36.7%) 
requirements 

the 
• 
entries 
disproportionate 
clinical 
evidence, particularly  in  relation  to  low-risk and 
legacy devices (CfE). 

discussed 
for 

166 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

•  A  manufacturer  association  reports  that  the 
attractiveness of Europe to be the first region for 
launching  diagnostic  innovations  has  decreased 
by 40% for large companies and 12% for SMEs 
(CfE). 

•  28  entries 
requirements 
disproportionate (CfE). 

(21.5%)  believe 

are  overly  burdensome 

that  PMS 
and 

• 98 entries (20.9%) discussed solutions related to 
proportionality  and  risk-based  approaches,  such 
as tailoring requirements to device risk levels, and 
reducing burdens for low-risk and legacy devices 
(CfE). 

Administrative burden 

•  Cost-efficiency of 
administrative 
costs 

respondents  agreed 

the 
•  <20%  of 
that 
the 
administrative  costs  of  complying  with 
Regulations are acceptable and will decrease once 
the Regulations are fully implemented (PC). 

•  Reporting 

requirements 

reporting  obligations:  Clinical 
•  Several 
Evaluation  Plan  (CEP),  Clinical  Evaluation 
Report  (CER),  Post-Market  Clinical  Follow-up 

- 

(negative) 

167 

•  Due 

to 

ongoing 
implementation,  there 
is  not  a  full  overview 
reporting 
of 
requirements. 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

•  Documentation 
requirements 

(PMCF)  Plan,  PMCF  Evaluation  Report,  Post-
Market  Surveillance  (PMS)  Plan,  PMS  Report, 
Periodic  Safety  Update  Report  (PSUR)  and 
Periodic  Summary  Report  (PSR),  Summary  of 
Safety  (and  Clinical)  Performance  (SSCP),  and 
Trend Report. 

• 13.5% (or 23/170) manufacturers indicated that 
they  had  submitted  MIRs  that,  after  further 
analysis,  did  not  fulfil  the  vigilance  reporting 
requirements (PC). 

•  <  ¼  of  national  inspection  reports  have  a 
corresponding  final 
inspection  report  (NCA 
survey). 

•  Some  PMS/Vig/MS  activities  are  duplicated 
between notified bodies and NCAs. 

• 221 entries are related to administrative burdens, 
with  183  of  these  entries  (82.8%)  explicitly 
criticising  the  excessive  administrative  burdens 
and  documentation 
the 
Regulations (CfE). 

requirements  under 

168 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

•  58  companies  and  10  business  associations 
indicate  that  the  increased  documentation  and 
administrative 
the 
requirements 
Regulations  do  not  significantly  enhance  device 
safety (CfE). 

under 

•  According  to  a  study  conducted  by  a  business 
association, approximately 60% of IVD and MD 
manufacturers find the administrative burden and 
associated costs the largest regulatory barriers for 
bring innovative products to market (CfE). 

• A health provider claimed that they would need 
up to 14 additional staff members to comply with 
Article  5(5)  of  the  IVDR,  highlighting  the 
significant  administrative  burden  placed  on 
academic hospitals (CfE). 

• In position papers, manufacturers emphasize the 
disproportionate impact of administrative burden 
on  SMEs  and 
innovation,  while  healthcare 
professionals and insurers prioritise transparency 
and data accessibility (PP). 

169 

 
 
 
Topic 

Indicator(s) 

Evidence 

Overall assessment 
(scale --/-/0/+/++) 

Comments/data gaps 

Digitalisation 

•  Electronic 

instructions for 
use (e-IFU) 

• At a survey to healthcare professionals, 88% of 
respondents  preferred  e-IFUs  compared  to  the 
paper version. 61% agreed that e-IFUs should be 
expanded  to  all  medical  devices,  and  a  further 
29%  supported  a  limited  expansion  to  devices 
where a healthcare professional trains the lay user. 

•  46  entries  (20.8%)  advocate  for  digitalisation 
and 
reduce 
administrative burdens (CfE). 

streamlined 

processes 

to 

•  A  business  association  proposed  the  formal 
requirements  (such  information  on  application 
filings  to  a  notified  bodies)  could  benefit  from 
further 
being  more  process  oriented  and 
digitalisation (CfE). 

170 

0 

(neutral) 

•  Digitalisation 

is  an 
evolving  field  which 
was  not  a  priority  of 
the  Regulations  when 
they were adopted. 

•  Limited  quantitative 

data available. 

 
 
 
 
 
 
 
Table 6: Overall evaluation table 

Evaluation 
criterion 

Section / Sub-area 

Summary of findings 

Score (--
/–/0/+/++) 

Section 4.1.1.1. Legal certainty, 
transparency and trust 

Effectiveness 

Section 4.1.1.2. Notified bodies, 
conformity assessments and 
clinical evidence 

• Legal certainty: Mixed. Fewer formal disputes and > 100 MDCG guidance docs, but 
stakeholders (CfE, PC) still perceive ambiguity and incoherence. 
• Transparency: Negative. EUDAMED incomplete, SSCPs limited, <50% of PC 
respondents agreed MDR/IVDR improved transparency. 
• Trust: Negative. CfE and PC show confidence not improved; ~56% of PC respondents 
disagree/strongly disagree that MDR/IVDR increased trust. 

• Resources: Mixed. NBs and FTEs have continuously increased. >30% FTEs dedicated 
to administrative and supporting tasks (NB survey). 
• Designation: Positive. Designation times have decreased. >90% of codes applied for are 
obtained, but there is low coverage for some codes (EC, internal sources). 
• Oversight: Negative. Not coordinated/harmonised. Divergent 
approaches/interpretations without effective central control (PC, CfE, PP). 
• Conformity assessment: Negative. New certificates take 6-18 months (QMS only) and 
13-24 months (QMS and product). 50% time spent with manufacturer. Time and costs are 
seen as barriers (PC, CfE, PP). 
• Clinical evidence: Mixed. Data gathering has increased, and expert panels have been 
established, but evaluations are incomplete and not available (PC, PP). 

Section 4.1.1.3.  Market 
functioning and level playing 
field 

• Market functioning: Mixed. Compared to 2017, the overall market is larger and more 
resilient, with long-term average annual growth of 6% for MD and 4.3% for IVD, 
however no direct translation proportional increase in innovation and competitiveness. 

– 

– 

– 

171 

 
 
 
Evaluation 
criterion 

Section / Sub-area 

Summary of findings 

Score (--
/–/0/+/++) 

• Innovation: Negative. Broad consensus across stakeholders (PP, CfE) that the current 
regulatory framework hinders innovation, particularly for SMEs, start-ups, and niche 
markets. >85% of PC respondents believe that the Regulations dd not contribute to 
innovation in the medical device sector in the EU. 
• Competitiveness: Negative. Stakeholders (governance study) state that due to the 
regulatory barriers, EU-based manufacturers seek market access/certification outside the 
EU. >80% of PC respondents believe that the Regulations did not contribute to 
competitiveness in the medical device sector in the EU. 
• Level playing field: Negative. Consensus among stakeholders (CfE, PP) that 
inconsistencies in the interpretation and implementation of the Regulations across MS and 
NB create an uneven playing field. >75% of PC respondents disagree that the Regulations 
contributed to an even playing field for EOs. 
• Availability: Negative. 65% of governance study respondents consider that the current 
regulatory framework contributes to little or not at all to the availability of devices for 
patients and users. Difficult to estimate the % of transitioned devices from Directives to 
Regulations. 

Section 4.1.1.4. Post-market 
surveillance, vigilance and 
market surveillance 

• Reporting: Mixed. Increased capacity to detect safety risks, but increased burden for 
economic operators (CfE, PC, PP). Duplication: of reports for EOs & of activities 
between NCAs and NBs. 
• Coordination: Positive. Increasing coordination and actions. EUDAMED not available 
yet or mandatory is a limitation. 

+ 

172 

 
 
 
Evaluation 
criterion 

Section / Sub-area 

Summary of findings 

Score (--
/–/0/+/++) 

• Perceptions: Positive. Stakeholders agree that devices are sufficiently monitored, and 
safety issues are adequately identified and addressed (PC). Evaluation complicated by 
predominance of legacy devices currently on the market. 

• Governance: Mixed. Increased complexity, which requires extra coordination and 
resources. 
• Predictability & Proportionality: Negative. The system is perceived as unpredictable 
and disproportionate, particularly towards lower-risk devices. 
• Administrative burden: Negative. Reporting obligations have increased without 
necessarily bringing intended added value for safety in all some areas.  
• Digitalisation: Mixed. e-IFU has been expanded. 

• Costs: Strong Negative. Industry representatives identify clinical evidence requirements, 
certification costs and administrative burdens as significant cost drivers, with implications 
such as product withdrawals and increased allocation of resources. 
• Benefits: Positive. Stakeholders acknowledge the potential for the Regulations to provide 
greater  predictability  and  legal  certainty,  reputational  gains  and  better  market  across 
through harmonisation. Benefits not yet fully realised however, ambiguity and inconsistent 
application remain a stakeholder concern. 

• Costs: Mixed. While average yearly compliance costs for importers and distributers vary 
widely  under  the  Regulations,  with  some  reporting  zero  additional  costs,  others  face 
significant financial burdens associated with verification checks. 

– 

0 

0 

Section 4.1.1.5. Simplification 
and streamlined procedures 

Section 4.1.2.1. Manufacturers 
(large & SMEs) 

Efficiency 

Section 4.1.2.2. 
Importers/distributors  

173 

 
 
 
Evaluation 
criterion 

Section / Sub-area 

Summary of findings 

Score (--
/–/0/+/++) 

Section 4.1.2.3. Notified bodies 

Section 4.1.2.4. National 
Competent Authorities 

Section 4.1.2.5. Health Providers 

• Costs: Negative. Notified bodies have faced resource-intensive costs due to designation 
processes, extensive documentation, and coordination with national authorities. 
•  Benefits:  Strong  positive.  The  Regulations  have  resulted  in  increased  revenues  for 
notified  bodies  due  to  higher  fees  charged  for  certificate  issuance  and  maintenance, 
positioning certification as a core revenue stream. 

•  Costs:  Negative.  National  competent  authorities  have  experienced  significant  (though 
expected) increases in human resource needs and IT infrastructure investments to manage 
the  new  regulatory  tasks  and  coordination  efforts,  disproportionately  straining  smaller 
authorities’ budgets and staff. 
•  Benefits:  Positive.  NCAs  have  gained  a  more  central  role  in  the  harmonized  market 
oversight, with clearer responsibilities and a stronger mandate for intervention. 

•  Costs:  Negative.  Health  institutions  bear  administrative  burdens  and  significant 
compliance costs under the Regulations, impacting research and patient care. 
•  Benefits:  Positive.  Despite  the  costs,  health  providers  acknowledged  improved  safety 
assurance and clinical evidence requirements, along with anticipated gains in transparency 
through Eudamed. 

Section 4.1.2.6. Patients and 
Users 

•  Costs:  Negative.  Patients  face  indirect  costs  through  reduced  device  availability  and 
delays in innovative product certification, particularly affecting individuals affected by rare 
diseases, paediatric conditions, and vulnerable groups. 

0 

0 

0 

0 

174 

 
 
 
Evaluation 
criterion 

Section / Sub-area 

Summary of findings 

Score (--
/–/0/+/++) 

Section 4.1.2.7. EU-level 
Governance 

Coherence 

Internal coherence 

External coherence 

Relevance 

– 

• Benefits: Positive. Patient organisations and consumer groups acknowledge strengthened 
regulatory frameworks through stricter clinical and performance requirements, enhanced 
post-market surveillance and traceability, and increased transparency. 

•  Costs:  Negative.  The  governance  structure  faces  substantial  IT  development  and 
maintenance costs, alongside significant resource investments for regulatory coordination, 
guidance development, and expert panel support. 
•  Benefits:  Positive.  The  reinforced  governance  system  at  the  EU  level  is  enhancing 
regulatory harmonisation, maintaining the EU’s global leadership in the medtech sector. 

Mixed. No major issues identified, however inconsistencies remains, such as relating to 
terminology and requirements between the Regulations and Annexes, with specific issues 
like undefined key terms contributing to uncertainty despite a high percentage of similar 
provisions. 

Mixed.  While  the  Regulations  align  with  broader  EU  health  policy  objectives  and 
contribute  to  international  cooperation  via  IMDRF,  consulted  stakeholders  report  low 
agreement  on  their  alignment  with  other  EU  legislations,  with  ongoing  challenges  in 
integrating newer frameworks and international guidance. 

Mixed. While the Regulations remain relevant for ensuring patient safety and transparency, 
particularly  through  stringent  requirements  and  tools  like  EUDAMED  and  UDI, 
innovation, 
long-term  effectiveness 
stakeholders  question 
competitiveness,  and  harmonised  market  functioning,  highlighting  concerns  about 
implementation challenges and disproportionate impacts on SMEs. 

in  promoting 

their 

0 

0 

0 

0 

175 

 
 
 
Evaluation 
criterion 

EU Added 
Value 

– 

Section / Sub-area 

Summary of findings 

Score (--
/–/0/+/++) 

Mixed.  The  Regulations  provide  significant  added  value  by  establishing  a  unified  legal 
framework  enhancing  safety,  surveillance,  and  vigilance,  preventing  inconsistencies  in 
patient protection across Member States. However, persistent divergences in interpretation 
and  implementation  hinder  realisation  of  intended  benefits,  with  varying  efficiency  and 
proportionality in cost impacts across stakeholders. 

0 

176 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX VII. EXPLANATORY DIAGRAMS 

Figure 1. Governance structure (source: European Commission, internal) 

177 

 
 
 
 
 
Figure 2. EUDAMED timeline (source: European Commission website) 

178 

 
 
 
 
 
 
The 4 first modules (below as quoted in the Commission Decision (EU) 2025/2371) will be mandatory to use from 28 May 2026, 6 months after the 
publication of the notice in the OJEU, in accordance with the transitional provisions set out in Regulation (EU) 2024/1860.341  

a)  Actor module - the electronic system on registration of economic operators referred to in Article 30 of Regulation 2017/745 and Article 27 of 

Regulation (EU) 2017/746; 

b)  UDI/devices module - the UDI database and the electronic system for registration of devices referred to in Articles 28 and 29 of Regulation (EU) 

2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746; 

c)  Notified bodies & Certificates module - the electronic system on notified bodies and certificates referred to in Article 57 of Regulation (EU) 

2017/745 and Article 52 of Regulation (EU) 2017/746; 

d)  Market Surveillance module - the electronic system on market surveillance referred to in Article 100 of Regulation (EU) 2017/745 and Article 

95 of Regulation (EU) 2017/746. 

The 3 first are already available on voluntary basis; Actor since December 2020; UDI/Devices and NBS & certificates since October 2021. 

The 2 remaining modules have the following status: 

•  Vigilance and post-market surveillance – audit planned for mid-2026 
•  Clinical Investigations and performance studies – under development 

341 See note 63, pg 13.  

179 

 
 
 
 
 
 
 
 
 
 
Figure 3. Median number of days for notified body designation under MDR/IVDR (source: European Commission, internal) 

180 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4. Total number of days for notified body designation under MDR/IVDR (source: European Commission, internal) 

181 

 
 
 
 
 
 
 
 
Figure 5. Median number of days for each milestone of the notified body designation process (source: European Commission, internal) 

DA – Designating Authority  
CAPA – Corrective and Preventative Action 
EC – European Commission  
JAT – Joint assessment team 
NANDO – New Approach Notified and Designated Organisations Information System 
PAR – Preliminary assessment review   

182 

 
 
 
 
 
 
Figure 6. Evolution of the number of notified bodies under the MDD/AIMDD and MDR (source: European Commission, internal) 

183 

 
 
 
 
 
 
 
 
Figure 7. Risk classification of medical devices (source: European Commission, internal) 

184 

 
 
 
 
 
 
 
 
 
 
Figure 8. Risk classification of in vitro diagnostics (source: European Commission, internal) 

185 

 
 
 
 
 
 
ANNEX VIII. STAKEHOLDER MAPPING  

(Source: based on Technopolis report342) 

Stakeholder group   

Influence   Interest   Expertise of group / reasoning  

European Commission 
and EU bodies, including 
the EMA   

High   

High    These bodies are central in coordinating 
the implementation of EU-level 
regulation and cross-border consistency 
– institutional and strategic role.   

Corresponding general user type (in surveys, public 
consultation)   
N/A  

High    

High    These authorities are directly 

EU/EEA public authority  

EU MS competent 
authorities for medical 
devices  

EU reference laboratories  High    

342 See note 25, pg 7.  

responsible for national implementation, 
monitoring and enforcement of the 
MDR/IVDR. They shape national 
policies and procedures and contribute 
to shaping EU-level policies and 
direction.   

High    The EU reference laboratories (EURL) 
conduct evaluations of IVDs to support 
conformity assessments of these 
devices. This involves the laboratory 
testing of the performance claims made 

N/A  

186 

 
 
 
 
 
 
by the manufacturer and the device’s 
compliance with safety and performance 
standards. The EURLs are a key 
component of the testing around IVDs , 
issuing a scientific opinion to the 
notified body on devices as requested 
and upholding the standards for IVDs in 
the European Union.   

Large EU based 
manufacturers 
developing, 
manufacturing, and 
placing medical devices 
on the market, and/or 
associations representing 
this group   
Notified bodies   

EU Authorised 
Representatives   
Healthcare professionals, 
and institutions, and/or 
associations representing 

High    

High     These groups are heavily affected by 

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

regulatory compliance requirements and 
contribute to discussions at EU level on 
MDR/IVDR implementation. 

High   

High    These bodies perform conformity 

assessments and issue related 
certifications, essential to establishing 
market access for medical devices.   

Notified body designated under MDR/IVDR (Art 2(42) MDR / Art 
2(34) IVDR)  

Medium    High     EU Authorised Representatives act on 

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

behalf of non-EU manufacturers. 

Medium    High     These groups use medical devices for 

Healthcare professionals / Healthcare professional associations  

the care and treatment of patients. They 
have an interest in the practical use and 
safety of these devices. They may have 

187 

 
 
 
this group (e.g. medical or 
clinical associations)  

Medium    High   

EU based SMEs and start-
ups developing, 
manufacturing, and 
placing medical devices 
on the market  

specific obligations under the 
MDR/IVDR if they manufacture, 
modify or reprocess devices within their 
institution. They also have reporting 
requirements for incidents or adverse 
events in the use of medical devices. 
However, they do not participate in 
assessments of those elements and are 
often not involved in regulatory policy-
making in a structured manner.    
Similar to large manufacturers, these 
groups are also highly impacted by 
compliance costs but generally are less 
represented at EU level discussions.  
These types of manufacturers may be 
underrepresented in data and evaluation 
of these Regulations, possibly due to 
limited resources to participate in 
European discourse.   

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

International and 
European standardisation 
bodies  

Medium    High    These organisations are relevant for 
development of standards on health, 
safety and performance of medical 
devices, as well as on quality and risk 
management, packaging etc. In 
particular, European standardisation 
organisations (CEN and CENELEC) 

N/A  

188 

 
 
 
play an essential role in adopting 
harmonised European standards, as 
specifically requested by the 
Commission in its decision-making 
process, mostly on the basis of standards 
developed by international 
standardisation organisations (ISO and 
IEC). Once received and assessed by the 
Commission, harmonised European 
standards are cited in the Official 
Journal of the European Union (OJEU) 
to provide presumption of conformity 
with the requirements of the 
Regulations. This is very useful for 
manufacturers for conformity 
assessment procedures on their devices, 
as well as for notified bodies and 
competent authorities in charge of 
market surveillance. 

Importers and distributors 
of medical devices in the 
EU, and/or associations 
representing this group   
Insurers, and/or 
associations representing 
this group   

Medium    High     These organisations have specific 

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

obligations under the MDR/IVDR.   

Medium    High   

Insurers have a strong interest in the 
price and type of medical devices on the 
market. They have a strong influence on 

N/A  

189 

 
 
 
 
which products are reimbursed at 
national level, access to these products, 
and healthcare provider behaviour, but 
less so in regulatory policymaking. 
Their degree of influence can be 
affected by the type of insurance 
systems in specific EU Member States.   

Medium    High     National healthcare systems have a 

EU/EEA public authority  

strong interest in the practical use and 
safety of these devices. However, these 
bodies are often indirectly involved in 
the upholding of standards around the 
safety, quality and performance of 
medical devices, relying on other bodies 
in the national or European sphere.   

Medium    High    Often closely linked to manufacturers 

N/A  

and influence implementation and 
compliance practices, with high 
technical input and interest.   

Medium    High     SPPPs have specific obligations under 
the MDR/IVDR.    

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

Medium    High     The ultimate end-users are directly 

EU citizen, non-EU citizen, patient organisation  

affected by safety, efficacy, 

190 

National healthcare 
systems, including 
Ministries of Health, 
public health bodies, and 
publicly funded 
providers100  

Regulatory affairs experts 
active in the medical 
devices field, and/or 
associations representing 
this group   
System/procedure pack 
producers (SPPP), and/or 
associations representing 
this group   
General public, patients 
and consumers, 

 
 
 
associations representing 
them (e.g. patient 
organisations)  

transparency and costs, but their 
influence is limited and indirect. Patient 
associations contribute to discussions at 
EU level.  

Medium    Medium   These organisations are relevant for 

International 
intergovernmental 
organisations and other 
international 
associations    
Large non-EU 
manufacturers developing, 
manufacturing, and 
placing medical devices 
on the market  

Medium    Medium   These organisations have a high 

regulatory convergence and reliance but 
have no formal power over EU decision-
making.    

compliance burden and must appoint EU 
Authorised Representatives in order to 
place their products on the EU market, 
and whilst are not formally/specifically 
involved in regulatory discussions in the 
EU, may be represented by EU 
manufacturer associations.    

N/A  

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

Non-EU/EEA countries     Medium    Medium   Non-EU Member States have no formal 
say in EU legislative processes, however 
may practice reliance on and/or have 
trade considerations affected by the 
MDR/IVDR. Indeed their frameworks 
and practices may indirectly influence 
EU policy making in the interests of 
international convergence in the field.  

Non-EU/non-EEA public authority  

191 

 
 
 
Clinical investigators   

Low   

High    Clinical investigators of medical devices 
must adhere to the ethical and regulatory 
standards.   

Healthcare professionals / Healthcare professional associations  

Digital health, software 
and AI-tech developers   

Low   

High     Digital health and AI are becoming 

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

increasingly relevant under the 
MDR/IVDR, especially with medical 
software being classified as a medical 
device and the resulting need to comply 
with the requirements set out in these 
Regulations. They are not always 
formally/specifically represented in 
consultations but may be represented by 
existing manufacturer associations and 
are an emerging group with growing 
interest and moderate influence in the 
industry.    

Ethics committees   

Low   

High    Ethics committees review clinical 

N/A  

Non-EU SMEs and start-
ups developing, 
manufacturing, and 

Low   

High   

investigation/performance study 
applications. Given these committees 
are run at national level and report to the 
national competent authorities, their 
influence at EU level is limited.    
Similar to large, non-EU manufacturers, 
these organisations have a high 
compliance burden and must appoint EU 
Authorised Representatives in order to 

Economic operator (Art 2(35) MDR / Art 2(28) IVDR)  

192 

 
 
 
placing medical devices 
on the market  

Other civil society 
organisations (CSOs)   

Independent experts from 
academic and research 
institutes active in 
medical devices  

place their products on the EU market. 
They are not directly involved in EU 
regulatory discussions, and may further 
be constrained by financial, human and 
knowledge resources available to 
them.    

Low    

High     CSOs bring ethical and social 

Non-governmental organisation (NGO)  

perspectives and represent (vulnerable) 
groups or themes, however, their 
institutional influence is 
limited. Examples include groups 
focusing on consumer protection, 
environmental protection, digital and 
privacy rights, and/or labour or workers’ 
rights.   

Low   

Medium   Experts contribute evidence and expert 

Academic/research institution  

analysis through publications, which 
may contribute to policy-making in an 
indirect fashion. They may also 
participate in policy and regulatory 
discussions, but this remains indirect 
influence which is often unstructured 
and in difficult-to-enter spheres.    

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