COMMISSION STAFF WORKING DOCUMENT Cost-savings 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) 1050 final  COMMISSION STAFF WORKING DOCUMENT Cost-savings 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) 1051 final} - {SWD(2025) 1052 final}  
 
 
Contents 

INTRODUCTION: POLITICAL, LEGAL CONTEXT AND OBJECTIVES ..................................... 6 
1. 
2.  MAIN ISSUES AT STAKE .................................................................................................................. 8 

2.1.  What is/are the problems and what are their drivers? ....................................... 8 
2.2.  How likely is the problem to persist? .............................................................. 10 
PROPOSED MEASURES AND THEIR ESTIMATED COST-SAVINGS ....................................... 11 

3. 

Part  I  –  Generation  of  Evidence  and  Procedures  for  Performance  Studies  and  Clinical 
Investigations ........................................................................................................................... 14 

3.1.  Non-clinical and clinical data requirements .................................................... 14 
3.2.  Performance studies and clinical investigations processes ............................. 16 
3.3.  Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and 

Performance (SSP) .......................................................................................... 18 

Part II – Elements of Conformity Assessment ...................................................................... 19 

3.4.  Simplification and clarification of classification rules .................................... 19 
3.5.  Simplifying Processes – Maintenance of certificates ...................................... 20 
3.6.  Simplification measures specific to certain devices ........................................ 27 
Part  III  –  Cross-cutting  simplification,  streamlining  processes  and  harmonisation  of 
activities .................................................................................................................................... 36 

3.7.  Support mechanisms ........................................................................................ 36 
3.8.  Efficiency of notified body designation and monitoring ................................. 40 
3.9. 
Internationalisation and competitiveness ........................................................ 41 
3.10.  Other actions to streamline compliance .......................................................... 42 
CONCLUSIONS ................................................................................................................................. 44 
4. 
5. 
BIBLIOGRAPHY ............................................................................................................................... 47 
ANNEX I:   SYNOPSIS OF STAKEHOLDER CONSULTATION ........................................................... 50 
ANNEX II:   SUMMARY OF COST-SAVINGS ........................................................................................ 56 
ANNEX III:   DISTRIBUTION OF DEVICES, CERTIFICATES, AND ENTERPRISES ......................... 59 

Table 1.1: Device distribution ................................................................................................ 59 

Table 1.2: Certificate distribution .......................................................................................... 60 

Table 1.3: Enterprise distribution.......................................................................................... 61 

ANNEX IV: DETAILED CALCULATIONS .............................................................................................. 62 

Generation  of  Evidence  and  Procedures  for  Performance  Studies  and  Clinical 

Investigations ................................................................................................... 62 

Table 1: Use of equivalence, real-world evidence, in silico and other methodologies ....... 62 

Table 2: Removal of mandatory clinical investigations for class IIa implantable devices 63 

Table 3: Authorisation and notification of performance studies ........................................ 64 

Table  4:  Coordinated  assessment  for  clinical  performance  studies  and  clinical 
investigations that are also part of clinical trials .................................................................. 65 

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Table 5: Summary of safety and clinical performance (SSCP) and Summary of safety and 
performance (SSP)................................................................................................................... 66 

Elements of conformity assessment .......................................................................... 67 
Table 6: Change management ................................................................................................ 67 

Table 7: Surveillance frequency ............................................................................................. 70 

Table 8: Sampling of technical documentation .................................................................... 71 

Table 9: Unannounced audits ................................................................................................. 73 

Table  10:  Replace  “re-certification”  by  “periodic  review”  and  remove  general  limit  of 
duration of certificates ............................................................................................................ 74 

Table 11: Periodic safety update reports (PSUR) ................................................................ 76 

Table 12: Analysis of serious incidents .................................................................................. 78 

Table 13: Class I reusable surgical instruments and Class A sterile IVDs ........................ 79 

Table 14: Technical documentation of near-patient tests .................................................... 80 

Table 15: Breakthrough devices............................................................................................. 82 

Table 16: Fee reductions ......................................................................................................... 83 

Table 17: Companion diagnostics (CDx) – Changes to INNs .............................................. 85 

Cross-cutting simplification, streamlining processes and harmonisation of activities86 
Table 18: Early advice and structured dialogue ................................................................... 86 

Table 19: Internationalisation and competitiveness ............................................................. 88 

2 

 
 
 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

CDx 

CE 

CTR 

EMA 

EU 

Companion diagnostic 

Conformité Européenne 

Clinical Trial Regulation 

European Medicines Agency 

European Union 

EUDAMED 

European Database on Medical Devices 

IFU 

IMDRF 

INN 

ISO 

IVDR 

JAT 

QMS 

MDCG 

MDR 

MDSAP 

NB 

PMCF 

PMS 

PMPF 

PSUR 

SME 

SSCP 

SSP 

SWD 

TD 

WET 

Instructions For Use 

International Medical Device Regulators Forum 

International Nonproprietary Name 

International Organization for Standardization 

In Vitro Diagnostic Medical Device Regulation 

Joint Assessment Team 

Quality Management System 

Medical Device Coordination Group 

Medical Device Regulation 

Medical Device Single Audit Program 

Notified Body 

Post-Market Clinical Follow-up 

Post-Market Surveillance 

Post-Market Performance Follow-up 

Periodic Safety Update Report 

Small and Medium-sized Enterprises 

Summary of Safety and Clinical Performance 

Summary of Safety and Performance 

Staff Working Document 

Technical Documentation 

Well-Established Technologies 

3 

 
 
1.  INTRODUCTION: POLITICAL, LEGAL CONTEXT AND OBJECTIVES 

The  European  medical  technology  sector  is  a  cornerstone  of  EU  health  systems  and  industrial 
competitiveness. Europe is home to over 38,000 manufacturers, 90% of which are small and medium-
sized enterprises (SMEs) and is the second largest market in the world following the US1. The sector 
contributes significantly to EU innovation, employment, and exports, while providing patients and 
healthcare professionals with life-saving and life-enhancing technologies. 

Regulation  (EU) 2017/745 on medical  devices  (MDR) and Regulation  (EU) 2017/746 on  in  vitro 
diagnostic medical devices (IVDR) were adopted in 2017. The Regulations aim to “establish a robust, 
transparent, predictable and sustainable regulatory framework for medical devices which ensures a 
high level of safety and health whilst supporting innovation” (MDR/IVDR recital 1) and further align 
it  with  international  practices.  The  Regulations  strengthened  clinical  and  performance  evidence 
requirements, oversight of notified bodies, transparency tools, and post-market surveillance, among 
other topics. 

During the implementation and transition to the Regulations, various issues were observed including 
bottlenecks in notified body capacity, high compliance costs for SMEs, duplication of reporting, and 
uneven uptake of digital tools. Due to implementation challenges, amendments to the Regulation's 
transitional provisions were necessary to mitigate the risk of possible shortages affecting the supply 
of medical devices to patients and healthcare systems. The MDR transitional period was extended 
across all device classes, subject to several conditions: to December 2027 for high-risk devices and 
December 2028 for medium risk devices2. Similarly, the IVDR transitional periods were extended 
twice3,4 and currently run until 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. The modules of 
the  European  database  on  medical  devices  (EUDAMED)  are  also  being  rolled  out  and  made 
mandatory  for  use  gradually,  in  order  to  mitigate  the  consequences  of  development  delays54.  In 
addition,  an  advance  warning  mechanism  for  supply  interruptions  and  discontinuations  was 
introduced6,7. The Medical Device Coordination Group (MDCG) has endorsed various guidance to 
support  the  implementation  of  the  Regulations.  Still,  based  on  experience  and  on  the  evidence 
collected  through  the  targeted  evaluation  of  the  Regulations8,  it  has  emerged  that  the  regulatory 
system would benefit from a more structural simplification of the Regulations. 

In view of the challenges encountered in transitioning to the new requirements and to respond to the 
calls  for  urgent  action  from  the  European  Parliament9,  the  Council10  and  a  large  number  of 
stakeholders, the Commission brought forward the planned targeted evaluation11 of the Regulations 
to 202412. The targeted evaluation assessed the effectiveness, efficiency, relevance, coherence and 
EU added value of the Regulations. The evaluation also focused on the availability of devices in the 
EU (including ‘orphan devices’ and devices for small populations), on the development of innovative 

1 MedTech Europe, Facts & Figures 2024, MedTech Europe website. 
2 Regulation (EU) 2023/607, OJ L 80, 20.3.2023, pp. 24–29, ELI: http://data.europa.eu/eli/reg/2023/607/oj. 
3 Regulation (EU) 2022/112, OJ L 19, 28.1.2022, pp. 3–6, ELI: http://data.europa.eu/eli/reg/2022/112/oj. 
4 Regulation (EU) 2024/1860, OJ L, 2024/1860, 9.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1860/oj. 
5 Refer to footnote 4.  
6 Refer to footnote 4. 
7 Manufacturers must notify relevant competent authorities, health institutions and downstream supply chain actors of potential supply 
issues or cessations of certain devices where there is a risk of serious harm to patients or public health (See further Section 4.1.1.3) 
8 [Placeholder for SWD targeted evaluation, SWD(2025)1051] 
9 Texts adopted - Urgent need to revise the medical devices regulation - Wednesday, 23 October 2024 
10 Necessary reforms in the Medical Device and In vitro Diagnostic Medical Device Regulations, 5 December 2024 
11 Refer to footnote 8. 
12 Article 121 of the MDR indicates that an evaluation report must be finalised by 27 May 2027. Those activities have been brought 
forward by at least three years. 

4 

 
 
devices, and on the costs and administrative burdens for operators, especially SMEs. The targeted 
evaluation  showed  that  while  the  Regulations  do  raise  safety  standards,  there  are  proportionality 
challenges, with high regulatory hurdles hampering EU businesses’ innovation in the EU and their 
competitiveness  at  global  level.  These  burdens  risk  undermining  innovation  and  competitiveness, 
resulting in decreased availability of devices and ultimately having a negative impact on patient care. 

The proposal also supports the competitiveness of the EU industry where the environment is strongly 
protected against pollution. MDs and IVDs need to comply with Union legislation in this area, in 
particular, the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals  (REACH)  or  applying  without  prejudice  to  the  provisions  of  the  Batteries  and  Waste 
Batteries  Regulation  and  the  Packaging  and  Packaging  Waste  Regulation.  Thus,  the  proposed 
revision is consistent with the European Commission’s objectives to achieve climate neutrality set 
out in the EU Climate Law and the Union’s Strategy on Adaptation to Climate Change, and more 
broadly  with  the  ‘do  no  significant  harm’  principle.  Furthermore,  the  proposal  aligns  with  the 
proposal  of  digital  product  passport  by  introducing  the  possibility  of  digital  labelling  which  will 
contribute to the reduction of paper use and contributing directly to climate neutrality. 

Further to the reports of Mario Draghi13 and Enrico Letta14, the need for regulatory frameworks that 
facilitate competitiveness, resilience and the EU’s strategic autonomy has become a key priority for 
the European Commission. The European Commission’s guidelines for 2024-202915 also include a 
strong  focus  on  reducing  administrative  burdens  stemming  from  EU  rules  and  simplify  their 
implementation. This was reiterated in the Commission’s Competitive Compass16 for the EU, which 
includes  as  part  of  its  horizontal  enablers,  among  others,  the  simplification  of  the  regulatory 
environment and the reduction of burden and further outlined in the Commission’s implementation 
and  simplification  agenda17.  Moreover,  the  European  Commission’s  Strategy  for  European  Life 
Sciences also highlights the need to address challenges such as fragmented funding and innovation 
systems,  regulatory  complexities  and  slow  market  uptake  to  help  Europe  regain  its  position  as  a 
global life sciences leader, driving innovation, economic growth, and job creation18. 

The targeted revision responds to these aims to streamline and future-proof the regulatory framework 
by reducing  the administrative burden, enhancing predictability and  making it more cost-efficient 
and proportionate, while maintaining its overall architecture and preserving a high level of public 
health and patient safety. The general and specific objectives of the Regulations remain unchanged 
(see Revised intervention logic, Staff working document on the targeted evaluation). The targeted 
revision does not aim to alter these objectives but to adjust and refine the framework so that those 
original objectives can be better achieved, in particular in ensuring a high level of protection of health 
for patients and users and to ensure a high level of transparency on medical devices for all actors and 
citizens.   

13 European Commission website, The Draghi report on EU competitiveness, September 2024. 
14 Enrico Letta, Much more than a market – Speed, Security, Solidarity, April 2024.  
15 Ursula von der Leyen, Europe’s choice, Political guidelines for the next European Commission 2024−2029, July 2024.  
16 A Competitiveness Compass for the EU, COM/2025/30 final.  
17 A simpler and faster Europe: Communication on implementation and simplification, COM/2025/47 final. 
18 Choose Europe for life science: A strategy to position the EU as the world’s most attractive place for 
life sciences by 2030, COM/2025/525 final 

5 

 
 
2.  MAIN ISSUES AT STAKE 

2.1. 

 What is/are the problems and what are their drivers? 

Experience  with  the  implementation  of  the  MDR  and  IVDR,  as  presented  in  the  staff  working 
document  (SWD)  on  the  targeted  evaluation19,  demonstrates  that,  while  the  Regulations  have 
strengthened safety and performance requirements, a range of structural inefficiencies, duplications, 
disproportionate obligations and divergent interpretations of the requirements have emerged. These 
unintended consequences have contributed to decreased availability of devices, longer certification 
timelines, higher compliance costs and uneven practices across the internal market. These challenges 
are hampering the EU’s competitiveness at global level and affecting patient care. 

The main problem areas can be grouped as follows: 

•  Evidence generation 

The framework places extensive emphasis on clinical and performance evidence, but in practice the 
requirements have proved disproportionate for lower-risk devices and well-established technologies 
(see  also  the  SWD  on  the  targeted  evaluation20,  sections  4.1.1.2.  and  4.1.1.5.).  The  current  rules 
restrict the use of evidence from equivalent devices, information from various types of literature, or 
non-clinical or pre-clinical data. This has made the use of equivalence difficult to operationalise and 
led to duplicative clinical investigations even where sufficient evidence already exists. Moreover, the 
authorisation of performance studies and clinical investigations is fragmented across Member States, 
with divergent procedures, timelines and fee structures. This results in duplicated submissions and 
high  costs  even  for  low-risk  studies.  Emerging  evidence  sources,  such  as  in  silico  models  and 
validated  computational  data  are  not  yet  fully  recognised,  creating  a  regulatory  lag  relative  to 
technological and scientific advances.  

•  Conformity assessment procedures 

Conformity assessment under the Regulations is procedurally dense and has limited proportionality. 
Obligations such as technical documentation sampling, validation of summaries of safety and clinical 
performance (SSCPs) for medical devices or summaries of safety and performance (SSPs) for IVDs, 
and  repetitive  post-market  documentation  apply  not  always  proportionately  across  risk  classes. 
Notified bodies may interpret legislation differently from the manufacturer and among each other, 
generating  uncertainty  for  manufacturers,  inconsistent  workloads  for  notified  bodies  and 
disproportionate costs (see also the SWD on the targeted evaluation; sections 4.1.1.2. and 4.1.1.5. 
under effectiveness and 4.1.2. under efficiency). 

•  Post-market and surveillance obligations 

The Regulations introduced new periodic reporting duties, notably the periodic safety update report 
(PSUR)  and  post-market  clinical  follow-up  (PMCF)/post-market  performance  follow-up  (PMPF) 
requirements. In practice, manufacturers must produce multiple overlapping documents (post-market 
surveillance  (PMS)  Plan,  PMCF  Plan,  PMCF  Evaluation  Report),  often  containing  the  same 
information (see also the SWD on the targeted evaluation8, sections 4.1.1.5. under effectiveness and 
4.1.2.  under  efficiency).  The  frequency  and  scope  of  PSUR  updates  and  notified  body  validation 
obligations have proven disproportionate, particularly for stable technologies with a history of safe 

19 Refer to footnote 8. 
20 Refer to footnote 8. 

6 

 
 
use. Parallel assessments of serious incidents by competent authorities and notified bodies add further 
duplication. 

•  Notified body oversight of maintenance of certificates  

The  system  relies  on  periodic  re-certification  and  annual  surveillance  audits  irrespective  of  risk 
profile or compliance history. This “one-size-fits-all” approach generates administrative peaks at re-
certification  time  for  both  manufacturers  and  notified  bodies,  diverting  resources  from  new 
certifications  (see  also  the  SWD  on  the  targeted  evaluation21,  section  4.1.2.  under  efficiency). 
Unannounced audits are conducted on a fixed schedule rather than triggered by risk signals, providing 
limited  added  value  for  consistently  compliant  operators.  Change  management  processes  remain 
unpredictable,  with  no  agreed  criteria  for  “substantial  changes”  (see  also  SWD  on  the  targeted 
evaluation22,  section  4.1.1.5.)  or  pre-approved  change-control  plans.  This  results  in  divergent 
practices and unnecessary notifications. 

•  Cross-cutting procedural fragmentation and lack of coordination 

Differences  in  national  procedures  for  study  authorisation,  vigilance  reporting  and  qualification 
decisions continue to fragment the internal market. The absence of a robust qualification mechanism 
leads to divergent interpretations on whether borderline products fall under the MDR/IVDR or other 
frameworks.  Similarly,  classification  disputes  are  often  resolved  by  national  authorities  without 
coordinating  with  each  other  (see  SWD  on  the  targeted  evaluation23,  section  4.1.1.1).  This 
undermines legal certainty and smooth operation of the single market. Moreover, the designation, 
monitoring and re-assessment of notified bodies involve repetitive steps and overlapping activities, 
consuming significant administrative capacity at national and EU level (see SWD on the targeted 
evaluation24, section 4.1.1.2). 

•  Limited support mechanisms and predictability for innovators  

Unlike other major jurisdictions,  the EU framework lacks structured, early-stage scientific  advice 
and  pre-submission  dialogue  mechanisms.  Manufacturers,  especially  SMEs,  face  uncertainty 
regarding  evidence  expectations  and  conformity  assessment  strategy,  often  resorting  to  external 
consultants at substantial cost (see also the SWD on the targeted evaluation25, section 4.1.1.2.). This 
absence  of  coordinated  advice  and  structured  dialogue  contributes  to  late  identification  of 
deficiencies during conformity assessment and repeated review cycles. 

•  International misalignment and competitiveness challenges 

Finally,  whilst  alignment  with  international  frameworks  such  as  International  Medical  Device 
Regulators Forum (IMDRF) is high, limited alignment with Medical Device Single Audit Program 
(MDSAP) constrains the EU’s global competitiveness (see also the SWD on the targeted evaluation26, 
section  4.1.1.3.  under  effectiveness  and  section  4.1.3.  on  coherence).  Duplication  of  audits  and 
divergent  evidence  expectations impose additional compliance  costs for  manufacturers seeking  to 
market devices internationally. 

21 Refer to footnote 8. 
22 Refer to footnote 8. 
23 Refer to footnote 8. 
24 Refer to footnote 8. 
25 Refer to footnote 8. 
26 Refer to footnote 8. 

7 

 
 
2.2. 

 How likely is the problem to persist? 

Without targeted regulatory simplification, these structural inefficiencies are likely to continue. The 
Regulations  are  directly  applicable  with  limited  administrative  flexibility.  Most  obligations, 
including  audit  frequency  and  evidence  thresholds  are  embedded  in  law,  leaving  little  scope  for 
harmonisation through experience or guidance alone. 

These inflexible requirements, combined with divergent practices as to the extent of assessments, 
will  continue  to  delay  certification  and  result  in  high  costs,  particularly  for  SMEs,  orphan  and 
breakthrough devices. 

Fragmented  national  procedures  qualification,  classification,  vigilance  and  other  aspects  of 
implementation  of  the  Regulations  create  persistent  divergence  that  cannot  be  resolved  without 
legislative clarification or EU-level coordination mechanisms. 

Certification and post-market reporting obligations are cyclical and tied to fixed frequencies in the 
Regulations. Without amendments, these will continue to impose repetitive administrative workload 
regardless of actual risk or performance. 

The  lack  of  formalised  early-interaction  tools  (structured  dialogue,  joint  scientific  advice)  limits 
learning and convergence between manufacturers and notified bodies; experience shows such tools 
have not been put in place spontaneously due to absence of legal basis and mechanisms to manage 
possible conflicts of interest. 

Finally, international fragmentation will persist unless the legal framework explicitly enables reliance 
and cooperation mechanisms with other regulators. 

Overall, the status quo is unlikely to improve spontaneously. While more experience with applying 
the Regulations over time may somewhat improve the efficiency of some processes, the structural 
inefficiencies and lack of proportionality  stemming from  the Regulations themselves will remain. 
Further explanation in the form of guidance is also insufficient to address the issues stemming from 
the Regulations themselves. Without intervention, the combination of high fixed compliance costs, 
limited  predictability,  and  uneven  implementation  will  continue  to  hinder  innovation,  strain  the 
regulatory system’s capacity, and slow patient access to safe and performant devices in the Union. 

8 

 
 
 
 
3.  PROPOSED MEASURES AND THEIR ESTIMATED COST-SAVINGS  

Overview of simplification measures 

The targeted revision of the MDR and IVDR aims to ensure that the Regulations’ original regulatory 
objectives to “establish a robust, transparent, predictable and sustainable regulatory framework for 
medical devices which ensures a high level of safety and health whilst supporting innovation” are 
achieved in a manner that is efficient, proportionate, and coherent. It does not imply a lowering of 
standards but rather a simplification and a shift toward more risk-based and data-driven approach 
through targeted measures, which preserve a high level of protection while improving the system’s 
functionality.  

Moreover,  these  measures  are  contributing  to  the  original  general  and  specific  objectives  of  the 
Regulation, in particular the two general objectives to ensure a high level of protection of health for 
patients and users and to ensure a high level of transparency on medical devices for all actors and 
citizens.  By  eliminating  unnecessary  administrative  burden  and  enhancing  coordination  among 
regulatory actors, the revision would support the timely availability of safe and innovative medical 
technologies  across  the  Union  and  reducing  the  risks  to  patient  safety  and  health  related  to 
discontinuation of devices and limited availability of innovation. 

Simplification  under  this  proposal  operates  along  several  complementary  dimensions  reducing 
redundant  requirements,  improving  proportionality,  strengthening  coordination,  and  enhancing 
predictability so that regulatory oversight becomes more data-driven, consistent, and focused on areas 
of highest public-health impact.  

Simplification actions fall broadly into four mutually reinforcing types, each contributing to a more 
predictable, coherent, and innovation-friendly regulatory environment. 

Simplification  type 1:  More  emphasis on risk-based rather than fixed frequency assessment 
approach 

Simplification can be achieved by shifting certain conformity-assessment activities from fixed and 
cyclical to a more flexible, risk-based approach, where activities are carried out when warranted and 
to  the  depth  appropriate  for  the  specific  case.  For  example,  the  current  annual  technical-
documentation sampling for class IIa and IIb non-implantable devices, as well as for class B and C 
IVDs,  would  be  replaced  by  targeted,  for-cause  assessments.  Similarly,  the  automatic  yearly 
surveillance audit cycle would be extended to every two years where there are no identified concerns. 

By  lightening  the  regular  administrative  workload  from  fixed  frequency  processes  for  both 
manufacturers and notified bodies, the move to more targeted activities would generate measurable 
cost savings associated with the preparation and assessment of documents and performance of audits.  
This  would  be  particularly  beneficial  for  SMEs,  which  are  disproportionately  affected  by  heavy 
administrative requirements. At the same time, it enables notified bodies, manufacturers, and where 
relevant  competent  authorities  to  concentrate  their  efforts  on  cases  that  present  higher  risk  or 
emerging concerns, rather than distributing resources across files that pose little or no issue.  

Simplification type 2: More appropriate differentiation between lower and higher-risk devices 

Several measures propose to reduce unnecessary administrative burden on certain lower risk devices 
for which specific needs have been identified, better reflecting the risks associated with their use (and 
when applicable, based on their safety history). The purpose is that the resources of manufacturers, 
notified  bodies  and  competent  authorities  would  be  more  focused  on  higher-risk  activities  where 

9 

 
more oversight is really needed, while maintaining minimum standards for lower risk devices overall, 
in  line  with  the  objectives  of  the  regulations.  This  includes,  for  example,  the  introduction  of  the 
definition  of  well-established  technologies  and  certain  exemptions  for  them,  adjustment  of 
classification rules notably  for software, removal  of authorisation  or notification requirements for 
certain performance studies, removal of obligation for clinical investigations for class IIa implantable 
devices, removal of notified body oversight for class A sterile IVDs and for class I reusable surgical 
instruments, provided they comply with standards or common specifications, or greater distinction 
in the extend of technical documentation sampling between class B and C IVDs.  

These proposals would result in significant reduction of burden on the manufacturers, as well as time 
saving  for  notified  bodies  and  competent  authorities,  and  allow  a  redistribution  of  resources 
ultimately focusing on higher risk devices and activities. These measures would greatly benefit SMEs 
as they are particularly active in the area of low-risk devices. 

Simplification type 3: Reducing burdens and redundancies in processes 

Simplification  also  addresses  burdensome  processes  and  procedural  overlaps  that  create 
disproportionate  efforts  or  duplication  in  conformity-assessment  and  oversight.  For  example,  re-
certification  that  currently  results  in  a  heavy  review  by  the  notified  body  and  a  re-issuance  of 
certificates is proposed to be replaced by a more focused and limited periodic review without the 
need to re-issue the certificate. The management of changes is also proposed to be streamlined with 
the use of pre-determined change control plans covering several changes at once, as opposed to their 
individual assessment.  To take another example, currently serious incidents  are reviewed by both 
competent authorities and notified bodies. The proposal would reduce this overlap by requiring the 
notified bodies to review only a limited subset of the most critical serious incidents.  

A  special  case  of  this  type  of  simplification  is  the  reinforcement  of  the  EU’s  role  in 
internationalisation,  through  reinforced  participation  in  the  IMDRF  and  the  use  of  reliance 
mechanisms  such  as  MDSAP.  The  EU’s  contribution  to  IMDRF  and  MDSAP  would  promote 
regulatory  convergence,  reduce  duplicated  audits,  and  enhance  the  global  competitiveness  of  EU 
manufacturers. 

Simplification type 4: Improving legal certainty and predictability 

There are two ways in which the proposal aims to provide more legal certainty and predictability. 
Firstly,  the  proposal  includes  clearer  definitions  or  criteria,  for  example  for  well-established 
technologies  and for breakthrough, and orphan devices.  It  also  includes clearer and more explicit 
descriptions for reliance on equivalence or use of methods such as in silico or other new approach 
methods, on which there can be currently different expectations between manufacturers and notified 
bodies.  

The second way of increasing legal certainty  and predictability is the introduction of mechanisms 
through which questions on individual cases can be resolved. This includes strengthened mechanisms 
to resolve issues of qualification or classification of devices, or the possibility for manufacturers and 
notified bodies to raise disputes with the authority responsible for notified bodies regarding issues 
during  a  specific  conformity  assessment  procedure.  Moreover,  there  are  proposals  for  support 
mechanisms to manufacturers such as joint scientific advice including both scientific and regulatory 
experts, and enhanced provisions for structured dialogue between the manufacturer and notified body 
prior to the submission of the application. Through these processes, the manufacturer would have 
greater clarity upfront about what would be expected during conformity assessment. The measures 
are also in line with the specific objective of the Regulations to increase the involvement of external 
scientific and clinical expertise. 

10 

 
This  legal  clarity  and  predictability  are  expected  to  yield  indirect  but  substantial  simplification 
benefits by reducing procedural delays, legal and consultancy costs, and uncertainty for innovators, 
ultimately lowering costs and reducing time to market. By ensuring consistent implementation across 
Member States, it would also reinforce the functioning of the single market. 

Overall, the simplification measures  proposed in  this targeted revision of  the Regulations seek to 
make  the  regulatory  framework  more  proportionate,  predictable,  and  innovation-friendly,  while 
maintaining  high  levels  of  safety  and  performance.  By  reducing  reporting  burdens,  streamlining 
conformity-assessment  and  oversight,  enhancing  legal  certainty,  and  modernising  regulatory 
cooperation, the revision supports the general and specific objectives of the Regulations, as well as 
the priorities of the Commission set out in the Competitiveness Agenda and SME Relief Package and 
strengthens the EU’s global leadership in medical device regulation.  

This SWD analyses the proposed simplification measures and quantifies cost savings, where possible. 
For each measure, a short description is provided followed by a quantitative or qualitative summary 
of the estimated cost savings. Annex I provides a summary of stakeholder feedback. Annex II of this 
document provides a summary table of the measures with the estimated cost saving where possible, 
type of simplification they provide, and the actors benefitting from them. Annex III provides the base 
distributions utilised for  the calculations,  whilst  Annex  IV contains detailed calculations  for each 
quantified measure.  

11 

 
  
 
 
PART  I  –  GENERATION  OF  EVIDENCE  AND  PROCEDURES  FOR  PERFORMANCE  STUDIES  AND 
CLINICAL INVESTIGATIONS  

Proposed measures  

3.1. 

 Non-clinical and clinical data requirements 

3.1.1.  Use of equivalence, real world evidence, in silico and other methodologies  

The revision clarifies that the term clinical data used for medical devices encompasses not only data 
generated  from  the  device  itself  but  also  relevant  data  from  an  equivalent  device,  from  a  generic 
device group or from literature. Manufacturers would no longer be required to  hold  a contractual 
agreement granting access to the equivalent device’s full technical documentation if equivalence can 
be  scientifically  demonstrated  on  the  basis  of  public  or  published  information.  In  addition,  the 
equivalence criteria are broadened by the addition of “similar” to the existing definition of generic 
device group27. This would permit the broader use of equivalence claims, improving proportionality 
and regulatory flexibility. The need to allow for greater flexibility in the definition of equivalence, 
and therefore in the evidence required, was highlighted in the call for evidence. 

The proposal also aims to acknowledge an increased reliance on the use of non-clinical or in silico 
evidence, including bench testing and computational modelling. This codifies the possibility to rely 
on  validated  modelling  approaches  as  well  as  other  forms  of  modern  methodologies  alongside 
existing practices. In the call for evidence, some stakeholders supported broader use of non-clinical 
evidence, real-world evidence and in silico methods. 

These proposed measures remain in line the specific objective of the Regulations of strengthened 
requirements  for  clinical  evidence.  The  measures  acknowledge  recent  developments  in  scientific 
evidence generation, also recognized in other markets, and the special context of certain devices (e.g. 
registries in the context rare diseases, etc). 

In addition to directly reducing costs for generating new clinical data, these changes are expected to 
generate further efficiencies. Broader acceptance of alternative evidence may also shorten the pre-
market  phase  by  several  months.  At  the  same  time,  there  should  be  fewer  disagreements  or 
misalignment of expectations between manufacturers and notified bodies with regard to acceptability 
of the alternative methodologies, reducing the number of clarifications and additional information 
required.  Competent  authorities  are  also  expected  to  carry  out  fewer  assessments  of  clinical 
investigations  where  the  revised  framework  allows  conformity  to  be  demonstrated  through 
alternative evidence sources. This contributes to  a more proportionate use of regulatory resources 
while maintaining a high level of oversight. 

27  ‘generic  device  group’  means  a  set  of  devices  having  the  same  or  similar  intended  purposes  and  a  commonality  of  technology 
allowing them to be classified in a generic manner not reflecting specific characteristics. 

12 

 
 
Cost savings:  

•  Stakeholder and expert inputs indicate that the cost of generating clinical evidence 
ranges from €125,000 - €1.5 million for medical devices and between €200,000 - 
€300,000 for IVDs. Allowing greater reliance on equivalence, real-world data and non-
clinical evidence enables a portion of packages to reduce costs, particularly those for 
modified devices as opposed to new devices.  

•  Based on an estimated 5,300 clinical-evidence packages/year and differentiated adoption 
rates for new vs modified devices, the annual cost savings are estimated at an average of  
€245 million per year. A large share of these savings are for modification of devices 
where the above methodologies are more often applicable compared to new devices. 

Detailed analysis can be found in Annex IV - Table 1 

3.1.2.  Removal of mandatory clinical investigations for class IIa implantable devices 

Under the current MDR Article 61(4), implantable devices (including class IIa implantable devices) 
are  presumed  to  require  clinical  investigations  unless  it  is  a  modification  of  an  already  marketed 
device of the same manufacturer and equivalence between these can be demonstrated. In practice, 
this creates a default investigation requirement even for low-risk implants (e.g. dental screws, braces, 
etc.) where post-market and literature evidence already exist. 

It is proposed to remove this default requirement for clinical investigations of class IIa implantable 
devices. Manufacturers would remain responsible for demonstrating and justifying that the available 
evidence  is  appropriate  during  the  conformity  assessment,  and  the  requirements  for  post-market 
surveillance, surveillance and vigilance remain unchanged. However, clinical investigations would 
only be carried out in those cases where already available clinical, literature or other non-clinical 
evidence  is  not  sufficient.  This  is  expected  to  reduce  the  number  of  clinical  investigations 
manufacturers need to design and conduct for these relatively low-risk devices, while maintaining 
the option to perform them investigations where it is essential. 

Overall, this step towards aligning the level of evidence requirements with the risk class of the device, 
as intended under recitals 63–66 of the MDR, enhances regulatory proportionality and frees resources 
for  genuinely  higher-risk  or  novel  technologies  where  new  clinical  investigations  add  value.  In 
addition,  competent  authorities  would  face  fewer  clinical  investigations  to  assess  and  approve, 
supporting more efficient use of regulatory capacity. 

Cost savings:  

• 

• 

• 

The cost of a class IIa device clinical investigation can be estimated at around €500,000 with 
typically around 50 patients enrolled. Around 40 such clinical investigations are estimated 
to take place in the EU per year.  
This gives an aggregate EU-wide estimated savings potential of €20.6 million per year for 
this measure. 
Further savings can be expected from faster access to market of these  devices, as clinical 
investigations require a significant time investment.  

Detailed analysis can be found in Annex IV – Table 2 

3. 

13 

 
 
 
 
 
3.2. 

 Performance studies and clinical investigations processes 

3.2.1.  Authorisation and notification of performance studies 

The revision aims to simplify the requirements for certain low-risk non-interventional performance 
studies, by removing the obligation for authorisation  of the study by Member State authorities  or 
notification  of  the  study  to  them.  This  namely  concerns  studies  with  low-risk  studies  involving 
surgically invasive specimen taking, such as those involving venous or capillary blood draws from 
non-vulnerable individuals and studies involving companion diagnostics using leftover samples. This 
aligns the level of regulatory scrutiny with the actual risk to participants and avoids disproportionate 
administrative effort for studies that pose negligible risk. The sponsors would face a significantly 
reduced  administrative  and  procedural  burden,  as  they  would  no  longer  need  to  prepare  full 
authorisation dossiers or submit notifications for studies with minimal risk. At the same time, national 
competent  authorities  would  save  resources  by  processing  fewer  applications  or  notifications, 
allowing them to focus oversight on higher-risk or more complex studies.  

Cost savings:  

•  For  performance  studies  using  routine  blood  draws,  using  data  from  authorities  on  the 
number of requests and estimations from industry, about 7 such studies can be estimated 
to take place in the EU per year with an average number of between 4-5 Member States 
per  study.  Taking  into  account  manufacturer  administrative  costs  and  fees  from  the 
authorities, a total saving for sponsors of around €200,000 per year can be expected from 
removing  the  authorisation  requirement.  It  would  also  save  about  €76,000  in  national 
competent authority resources. 

•  For notifications of studies involving companion diagnostics and left-over samples, about 
280 of them can be estimated to be made across the EU per year based on data provided 
by national competent authorities. Removing the notification requirement is expected to 
save around €410,000 per year for sponsors and about  €112,000 in national competent 
authority resources.  

Further savings can be expected from the gain in efficiency due to removal of these requirements, 
meaning that the studies can be started sooner and ultimately the devices may reach the market 
and patients faster.  

Moreover,  currently  the  number  of  such  studies  in  the  EU  may  be  low  due  to  the  high 
administrative burden and therefore the sponsors’ preference for conducting them elsewhere. The 
removal  of  the  requirements  is  an  incentive  for  more  such  studies  to  take  place  in  the  EU, 
stimulating innovation and ultimately faster access of EU patients to new devices.   

Detailed analysis can be found in Annex IV - Table 3 

3.2.2.  Enable coordinated assessment for clinical performance studies and clinical 

investigations that are also part of clinical trials 

Under the current framework, where a clinical investigation of a medical device is conducted jointly 
with  a  clinical  trial  of  a  medicinal  product  (for  example,  for  a  drug–device  combination  or  a 
companion diagnostic), the sponsors must undergo two parallel regulatory processes—one under the 
MDR or IVDR for the device part and one under the Regulation (EU) No 536/2014 on clinical trials 

14 

 
 
 
on medicinal products (CTR)28. This dual process leads to a high administrative burden, difficulty 
for  the  sponsors  to  manage  potentially  different  views  of  various  Member  State  authorities, 
misaligned timelines and delays. The proposed revision is in line with the findings of the targeted 
evaluation on the need to increase the coherence between the MDR and IVDR with the CTR. The 
revision  of  the  IVDR,  MDR  and  CTR  on  this  point  enables  a  coordinated  assessment  between 
competent authorities responsible for the three Regulations, when both the device and the medicinal 
product are studied together. For the performance study or clinical investigation component that is 
part  of  a  combined  study,  the  sponsor  has  the  option  of  going  through  a  combined  authorisation 
process  described  specifically  for  these  studies  in  the  CTR,  rather  than  be  subject  to  a  separate 
assessment  under  either  the  IVDR  or  the  MDR.  This  measure  aims  to  reduce  procedural 
fragmentation, facilitate integrated clinical  studies, and align the EU framework with  other major 
jurisdictions  that  already  allow  combined  or  harmonised  submissions  for  such  studies.  It  also 
responds  to  stakeholder  feedback  from  industry  on  the  need  for  more  efficient  processes  for 
integrated  studies  involving  both  medical  devices  and  medicinal  products.  Manufacturers  are 
expected  to  benefit  from  reduced  administrative  workload  and  improved  predictability,  while 
national  competent  authorities  would  save  resources  by  avoiding  duplication  of  assessments  and 
coordinating efforts across regulatory domains. 

Cost savings:  

Since the combined coordinated process would be put in place under the CTR, in this analysis 
focusing on the medical devices only a simple estimate of the reduction of administrative costs 
for the device part is made. In addition, since the great majority of combined studies involve IVDs 
rather than medical devices, the analysis is focusing on the cost savings for performance studies 
of IVDs that are linked to a clinical trial.  

•  Data  from  national  authorities  indicate  an  annual  volume  of  477  applications  for 
performance  study  authorisations,  of  which  approximately  78%  are  linked  to  clinical 
trials. Using an average of about 4-5 Member States per study, this gives about 80 studies 
linked to a clinical trial per year.  

•  For performance studies connected to clinical trials, administrative costs for sponsors and 
authorities  amount  to  an  estimated  €1.5  million  per  year.  Introducing  a  coordinated 
assessment  is  expected  to  reduce  procedural  duplication  by  around  30%,  generating 
savings for the performance studies of approximately €367,000 per year. 

These estimated savings do not take into account cost savings on the clinical trials side of the 
combined study or savings for clinical investigations of medical devices combined with a clinical 
trial. Moreover, they do not take into account missed opportunity costs due to delays to the start 
of the performance studies and clinical trials, which the stakeholders indicate as significant. The 
overall savings are therefore expected to be much higher than the above.  

Detailed analysis can be found in Annex IV - Table 4 

28 OJ L 158, 27.5.2014, pp. 1–76, Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on 
clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 

15 

 
 
 
 
 
3.3. 

 Summary of Safety and Clinical Performance (SSCP) and Summary of Safety 

and Performance (SSP) 

The revision proposes a targeted streamlining of the SSCP under the MDR and the SSP under the 
IVDR, with the aim of reducing unnecessary documentation and validation burdens while preserving 
the transparency and accessibility of information. 

Under the current framework, manufacturers of all implantable and Class III devices (MDR), as well 
as Class C and D IVDs (IVDR), are required to prepare a SSCP / SSP that is validated by the notified 
body and made publicly available for the users and, where relevant, for the patients. In practice, these 
summaries impose recurring costs for drafting, translation, validation and publication and, especially 
for IVDs, duplicate certain information already contained in the instructions for use (IFU), which are 
made  available  to  users  and  will  also  be  made  publicly  available  through  EUDAMED.  Thus,  the 
proposed changes are still in line with the general objective of the Regulations to ensure a high level 
of transparency of medical devices for all actors and citizens.  

The proposed adjustments include the following: 

•  Remove the obligation to prepare an SSCP for class IIa implantable and  WET devices, as 
well as for SSP for class C IVDs for professional use which are not companion diagnostics. 
•  Enable  the  manufacturer  to  draft  the  SS(C)P  in  a  language  readable  by  professionals  and 

remove the requirement to provide an additional section in lay language. 

•  Remove  the  systematic  requirement  for  notified  body  validation  of  the  SS(C)P  before 
publication.  The SS(C)P would be reviewed as part of the technical documentation (TD) of 
a device either during initial certification or during surveillance (if the TD file is selected by 
the notified body).    

•  For IVDs, remove overlapping content with the IFU to ensure that the SSP provides easy-to-
navigate  non-duplicative  information,  and  make  the  IFU  publicly  available  through  the 
EUDAMED database. 

These measures maintain transparency while avoiding duplication and non-essential costs for higher-
risk devices while reducing burden for lower-risk devices. Manufacturers would benefit from reduced 
drafting, translation, and validation costs, and notified bodies would save resources by reviewing less 
documentation. At the same time, clinicians, patients and researchers would continue to have access 
to the additional information from the SS(C)P on clinical and performance evaluation on the higher-
risk devices.  

16 

 
Cost savings: 

Cost saving is expected for internal manufacturer costs due to the removal of validation costs by 
the notified body and the reduction of the number of pages in the SS(C)P files, and. 

•  The notified body fees for initial validation of SS(C)Ps vary between €1 200 – 4 000 per 
document. The savings expected from removing this separate validation step are around 
€20.7  million.  In  addition,  assuming  that  there  is  one  update  per  year  of  the  SSCP 
document,  which  would  currently  also  need  to  be  validated  by  the  notified  body  with 
similar fees, there would be additional savings on the order of €20 million per year. 

•  The manufacturer costs for drafting and translating an SSCP reach €42 000 – 70 000, with 
the equivalent costs for an IVD SSP of €17 250 – 28 750. Removing the part of the SSCP 
in lay language, for those SSCPs that are likely to have this additional part, can generate 
savings of around €13 million.  For IVDs, there is an additional cost saving from removal 
of duplication with the instructions for use. The combined reduction of the number pages 
of the SSP for IVDs is expected to yield a saving of €11.3 million.  

Detailed analysis can be found in Annex IV - Table 5 

PART II – ELEMENTS OF CONFORMITY ASSESSMENT   

• 

Proposed measures – Part IIA  

3.4. 

 Simplification and clarification of classification rules 

The revision proposes a targeted revision and clarification of the classification rules under Annex 
VIII of the MDR, with the objective of improving legal clarity, predictability, and consistency in the 
application of classification principles. This adjustment does not alter the overall level of safety and 
performance required for medical devices; rather, it ensures that products are classified in a consistent 
and proportionate manner across the Union, to ensure smooth functioning of the internal market, and 
improve the competitiveness of the Union. 

The key proposed changes include: 

•  Re-classification of reusable surgical instruments intended for transient or short-term use to 
class  I,  under  Rules  6  and  7,  recognising  their  long  history  of  safe  use  and  standardised 
manufacturing. 

•  Re-classification of most accessories for active implantable devices, meaning that they would 
be classified in their own right based on actual risk, instead of being automatically assigned 
to the highest class (Rule 8). 

•  Re-classification  of  well-established  technologies  (WET)  used  as  components  in  joint 
replacements  or  spinal  disc  replacements,  reflecting  mature  designs  and  extensive  post- 
market data (Rule 8).  

•  Addition of accessories for Annex XVI products (i.e. products with no medical purpose but 
similar function or risk profile) and adaptation of Rule 9 to cover these products, ensuring 
coherent treatment under the MDR. 

•  Alignment  of  software  classification  (Rule  11)  with 

international  guidance  (e.g. 
IMDRF/SaMD  WG/N81  FINAL:  2025),  leading  to  re-classification  of  certain  software 

17 

 
 
 
 
functions  whose  risk  lies  primarily  in  information  provision  rather  than  direct  patient 
management. 

These proposed changes strengthen legal  certainty for manufacturers and authorities by codifying 
long-standing interpretations and aligning classification approaches with international norms. They 
aim to reduce divergent national or notified body interpretations, which currently lead to inconsistent 
classification outcomes for similar products. 

By ensuring that classification reflects actual risk and technological maturity, the revision enhances 
predictability  and  proportionality  within  conformity  assessment  procedures.  This  contributes  to 
greater transparency of regulatory pathways, which is particularly beneficial for SMEs and software 
developers entering the EU market. Importantly, the simplifications do not affect patient safety, as 
the above proposed classification is appropriate for the risk posed by the devices, and they would still 
undergo conformity assessment according to the procedures determined by that class, as well as being 
subject to post-market surveillance, market surveillance and vigilance requirements.  

Collectively, the proposed adjustments clarify the boundaries between classes, reduce interpretative 
divergences among manufacturers, notified bodies, and competent authorities, and provide clearer 
guidance to manufacturers at the earliest stages of product development. 

The cost savings from this measure arise both from avoiding disproportionately rigorous and costly 
conformity-assessment procedures for the devices concerned, and from consequently enabling their 
faster access to the market. It also promotes a more efficient use of notified body resources, allowing 
them  to  focus  on  higher-risk  or  more  complex  assessments  where  their  expertise  is  most  needed. 
Greater regulatory efficiency resulting from this measure would also help ensure that patients benefit 
from an earlier and broader availability of these devices. 

Note: While this measure is expected to generate efficiencies and potential cost savings, these cannot 
be reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.5. 

 Simplifying Processes – Maintenance of certificates  

3.5.1.  Change management 

The medical device and in vitro diagnostic medical device sectors are characterised by continuous 
iterative technological improvements. Manufacturers routinely introduce design refinements, process 
optimisations, or material substitutions to enhance device quality or adapt to evolving standards. This 
implies changes to their quality management system (QMS) or technical documentation of devices, 
which may be covered by QMS or product certificates.  

There are different levels of oversight for changes, depending on their extent. Certain changes can be 
implemented by the manufacturer without the need for prior approval of the notified body, with some 
of these needing to be reported. Major changes need to be assessed by the notified body, who would 
decide whether additional conformity assessment activities and / or updates of the certificate(s) are 
needed.  

To  support  a  more  proportionate  and  internationally  aligned  approach  for  changes  that  currently 
require  prior  approval  from  a  notified  body,  the  revision  would  introduce  the  possibility  of  a 
predetermined change control plan (PCCP). This plan would be agreed between the manufacturer 
and  the  notified  body  in  advance,  defining  the  boundaries  within  which  modifications  may  be 
implemented without further prior notified body notification and approval. The type of change that 

18 

 
could  be  covered  by  it  can  include  certain  changes  related  to  the  manufacturing  process  (e.g. 
replacement of equipment) or to the characteristics of the product (e.g. changes to the shelf life of the 
device when there is a validated protocol for its determination, or certain changes to software as a 
medical device). This approach is aligned with international regulatory principles, in particular with 
the  work  of  the  IMDRF  on  change  management  of  software,  promoting  global  convergence  and 
predictability for manufacturers operating in multiple jurisdictions. It aims to provide a structured 
and transparent mechanism for handling changes, improve predictability and efficiency to the change 
management  process  while  maintaining  a  high  level  of  regulatory  oversight  through  a  continued 
control over modifications that could impact safety or performance. Manufacturers are expected to 
benefit  from  reduced  administrative  and  compliance  costs  and  shorter  timelines  linked  to  change 
notifications. Notified bodies would save resources by preliminary approval of planned changes and 
decrease  of  change  notifications  thereof.  Patients  would  benefit  from  timely  access  to  improved 
devices, as non-critical changes can be implemented more rapidly without compromising safety or 
performance. 

Cost savings:  

•  An estimation of number of changes submitted to notified bodies per year was estimated 
based  on  surveys  with  both  notified  bodies  and  manufacturers,  for  QMS  distributed 
according  to  manufacturer  size  and  for  technical  documentation  independent  of 
manufacturer size. Average notified body review fees amount to around €17,500 per QMS 
change and €52,500 per technical documentation change.  

•  Estimates  from  industry  indicate  that  savings  from  managing  eligible  changes  under  a 
PCCP would be about a third of current costs. This factor considers that firstly only certain 
changes  would  be  eligible  to  be  covered  by  a  PCCP,  and  secondly  that  preparing  and 
reviewing the PCCP would also generate certain costs. 

•  Combining the above information for both medical devices and IVDs, the shift of eligible 
changes into PCCPs would generate annual savings of approximately €477.6 million.  
This  calculation  does  not  take  into  account  the  internal  administrative  costs  of  the 
manufacturers,  which  would  also  decrease if eligible changes can be managed under  a 
PCCP  rather  than  individually.  Therefore,  the  above  saving  is  likely  to  be  an 
underestimate.  

Detailed analysis can be found in Annex IV - Table 6 

3.5.2.  Surveillance frequency 

The proposed revision provides for a more flexible approach to the frequency of surveillance audits 
performed by notified bodies as part of the conformity assessment activities under the Regulations. 
Currently, manufacturers are subject to annual surveillance audits irrespective of their portfolio, the 
nature of their devices, the performance of their QMS, or post-market feedback. While this aimed at 
ensuring continuous oversight, a high frequency of surveillance audits for all manufacturers may not 
always be proportionate to the level of risk or justified by available post-market data. 

With a more proportionate approach aimed at improving efficiency, the revised framework would 
allow surveillance audits to take place every two years, where this is supported by good compliance 
history of the manufacturer and absence of concerns coming from post-market feedback.  

19 

 
 
 
Manufacturers  are  expected  to  benefit  from  lower  audit-related  costs  and  reduced  operational 
disruption, while notified bodies would save time and resources by focusing surveillance efforts on 
manufacturers or devices that present higher or evolving risks. 

Cost savings:  

•  Annual surveillance audit costs for MDR and IVDR manufactures are around €13,750 for 
micro and small manufacturers, €37,000 for medium-size manufacturers, and €85,000 for 
large manufacturers.  

•  These costs can be applied to the expected future number of MDR and IVDR certificates 
distributed by enterprise size (8,452 micro/small; 3,694 medium; 3,229 large) and reduced 
by  20%  to  take  account  of  activities  that  may  be  combined  (e.g.  with  MDSAP  or  ISO 
13485). This yields a total annual surveillance audit burden of approximately €529 million. 
•  Allowing  surveillance  audits  to  take  place  every  two  years,  where  justified  based  on 
compliance  history,  PMS/vigilance  performance,  and  the  absence  of  significant  safety 
concerns,  would  reduce  the  number  of  audits  required  each  year.  It  can  be  reasonably 
assumed that between 10-50% certificates could benefit from biennial rather than annual 
audits.  

•  Taking  a  30%  eligibility  rate  for  reduced-frequency  audits,  annual  savings  can  be 

estimated at: €63.5 million. 

This calculation does not take into account the reduction in internal costs of the manufacturer and 
less  disruption  to  the  operation  of  the  manufacturer  due  to  lower  audit  frequency,  so  this  is 
expected to be an underestimate. 

Detailed analysis can be found in Annex IV - Table 7 

3.5.3.  Sampling of technical documentation  

Under  the  current  Regulations,  notified  bodies  are  required  to  assess  the  TD  for  “at  least  one” 
representative device per generic device group (class IIb and C) and per category (class IIa and B) 
prior  to  issuing  a  certificate.  In  addition,  notified  bodies  must  continue  assessing  technical 
documentation on a sampling basis during surveillance activities, ensuring that the entire range of 
devices  covered  by  the  certificate  is  sampled  during  the  certification  period.  In  practice,  this 
formulation  in  conjunction  with  the  MDCG  guidance  on  sampling  has  resulted  in  high  time  and 
resource  costs  for  both  manufacturers  and  notified  bodies,  and  divergent  practices  hampering  the 
functioning of the internal market. While this systematic approach provides continuous verification, 
it is unwarranted for devices with proven safety and performance history supported by post-market 
data. It may even include repetitive review of unchanged documentation. 

To strengthen proportionality and efficiency, the proposed revised approach is to: 

• 

require that only one TD per representative generic device group or category is assessed for 
initial certification for classes IIa and IIb medical devices and class C IVDs, and one device 
per manufacturer’s portfolio for class B IVDs; 

•  exclude assessment of aspects related to the design for class IIa devices; 
•  apply  a  more  proportionate  approach  during  initial  certification  of  devices  that  are  well 

established technologies; 

•  discontinue the requirement for systematic annual TD sampling during surveillance audits; 

20 

 
 
 
 
• 

limit TD reviews after initial certification to “for cause” assessments, triggered by specific 
information  from  vigilance,  PMS  a,  significant  changes  notified  under  the  QMS,  possible 
QMS non-compliances, or other justified concerns; and 

•  clarify  that  notified  bodies  remain  empowered  to  request  TD  review  at  any  time  where 

necessary to verify continued compliance. 

These measures shift the approach from regular comprehensive activities to more risk-based selective 
oversight, reducing burden and ensuring that regulatory attention is focused on areas where it adds 
demonstrable value to patient safety. Manufacturers would see reduced administrative costs related 
to TD sampling, while notified bodies would be able to use their time and expertise more efficiently 
by limiting detailed reviews to cases where the level of risk warrants it, such as cases where PMS, 
vigilance trends, QMS findings or significant changes may indicate a genuine safety or performance 
concern. 

Cost savings:  

•  TD sampling under the current regime represents a major recurring cost driver. The biggest 
one is the sampling during annual surveillance after the certificate is issued, so the cost 
saving calculation is focusing on this element.  

•  The number of generic device groups / categories per manufacturer, the typical number of 
TDs reviewed per surveillance, and sampling fees can vary. A representative TD sampling 
landscape for different manufacturer sizes and device classes was developed using data 
from notified bodies, analysis of certificates and expert input.  

•  The total current costs of TD review on a sampling basis during annual surveillance were 

estimated at €1.4 billion per year.  

•  Removing systematic TD sampling and limiting reviews to “for-cause” assessments would 
substantially reduce annual review volumes.  Three scenarios were modelled, with  “for-
cause” assessments accounting for 10%, 20% or 30% of current TD review volume. Using 
the 20% rate, the annual savings amount to €1.1 billion.     

These savings calculations are based only on the notified body review fees and do not take 
into  account  the  decrease  in  manufacturer  internal  administrative  costs  associated  with  the 
lower TD sampling rates. The real savings should therefore be even greater.  

Detailed analysis can be found in Annex IV - Table 8 

3.5.4.  Unannounced audits 

Under  the  current  provisions  of  the  Regulations,  notified  bodies  must  perform  at  least  one 
unannounced audit during each five-year certification cycle. This strict requirement ensures a high 
level  of  regulatory  control  but  applies  flatly  to  all  manufacturers,  without  considering  real  needs, 
track  record  of  compliance,  or  the  manufacturer’s  performance  in  PMS,  ultimately  resulting  in 
possible superfluous verifications being conducted. The revision introduces a more targeted and risk-
based approach to unannounced audits conducted by notified bodies. 

The revised approach replaces the mandatory frequency with a more flexible needs-based principle, 
whereby unannounced or short-notice audits are carried out “for cause”, e.g. based on vigilance cases, 
non-compliance, PMS outcomes, or market surveillance signals. Routine unannounced audits would 
therefore no longer be a fixed procedure applied uniformly to all manufacturers but would remain a 
valuable tool for notified bodies to be applied in case of potential risk or concern. 

21 

 
 
 
 
 
 
This change maintains the high level of safety required under the Regulations while aligning audit 
practices with the principles of proportionality and evidence-driven oversight. It would also reduce 
unnecessary burden and generate cost savings for manufacturers, while freeing up notified bodies’ 
resources to focus on areas of higher regulatory relevance.  

Cost savings:  

•  Under the existing fixed requirement of one unannounced audit per five-year cycle, across 
all  MDR  and  IVDR  expected  QMS  certificate  holders,  unannounced  audits  currently 
entail an estimated total cost of €200 million.  

•  By  replacing  the  fixed  frequency  with  a  targeted,  risk-based  approach,  the  number  of 
audits would decrease. Three scenarios were considered, in which 30%, 50% or 70% of 
audits would remain. The 50% reduction would result in total estimated savings of €62.7 
million per year. 

This  calculation  does  not  take  into  account  the  internal  manufacturer  costs  related  to  audit 
activities as well as the savings from the manufacturer’s operational disruption during the audit. 
Therefore, the actual savings are expected to be greater.  

Detailed analysis can be found in Annex IV - Table 9 

3.5.5.  Replacement  of  ‘re-certification’  by  periodic  review  and  removal  of  general 

duration limit of certificates 

The  revision  replaces  the  current  re-certification  process  with  a  system  of  periodic  review  of 
certificates conducted by notified bodies. Under the existing framework, certificates are limited to a 
maximum  duration  of  five  years,  at  the  end  of  which  a  re-certification  procedure  is  required. 
According  to  some  stakeholders,  this  in  practice  creates  unnecessary  duplication  of  work  already 
performed, significant administrative burden with limited added value in terms of safety benefit and 
possible  negative  impact  on  tender  procedures  and  third-country  registrations.  The  heavy  re-
certification procedure also presents unnecessary overlap with continuous post-market surveillance 
of the manufacturer, the surveillance by the notified bodies, and market surveillance and vigilance.  

The  measure  introduces  a  more  proportionate  regular  review  mechanism  in  the  form  of  periodic 
review  of  certificates,  ensuring  continuous  oversight  of  certified  devices  while  reducing 
administrative  burden  and  possible  duplication  of  assessments.  Periodic  review  would  focus  on 
elements relevant to guarantee continued compliance such as alignment to the state of the art, impact 
of  changes,  and  PMS  outcomes.  The  revision  also  proposes  removal  of  the  maximum  five-year 
validity limit for certificates issued by notified bodies and a system in which certificates remain valid 
provided that the manufacturer continues to comply with the applicable requirements as confirmed 
by the notified body’s oversight. Notified bodies would nevertheless retain the possibility to limit 
certificate duration when needed. 

This measure is expected to generate cost savings for manufacturers and reduce the administrative 
burden associated with full-recertification cycles. It would also save time and resources for notified 
bodies. Removing the maximum validity aims to reduce administrative workload for both notified 
bodies and manufacturers, ensuring uninterrupted market presence of compliant devices and avoiding 
administrative  bottlenecks.  The  measures  are  also  expected  to  facilitate  third-country  regulatory 
registrations, as many jurisdictions require proof of valid up-to-date EU certifications. All in all, it 

22 

 
 
 
 
 
 
reflects a shift from fixed validity cycles to continuous monitoring based on performance, risk and 
post-market data.  

Cost savings:  

•  Re-certification for the quality  management system  currently involves an  audit, with  a 
major factor in the cost being the size of the manufacturer and their portfolio (e.g. €20,000 
for a micro manufacturer and €100,000 for a very large manufacturer). It also involves 
sampling of the technical documentation, similar to what would be expected in a typical 
surveillance year. For technical documentation certificates, the re-certification involves 
review of the technical  documentation taking into account  possible changes that might 
have been made during the certification cycle. 
•  Cost reductions from the proposed measure include: 

o 

o 

 around 10% administrative savings from removing the need for re-issuance of the 
certificate, 
the reduction of technical documentation sampling activities during surveillance, 
taking  into  account  the  policy  change  described  in  section  3.5.3,  applying  a 
somewhat  lower  saving  due  to  some  additional  activities  of  scanning  and 
reviewing changes in technical documentation, 

o  for product certificates the reduction of costs of technical documentation review 

due to the expected reduced depth of assessment to about 60%.  

•  Combined  savings  across  medical  device  and  IVD  sectors  from  the  above  factors  can 
reach an aggregate of €1.1 billion per current 5-year cycle, or about €227 million per year.  

This calculation does not take into account the reduction in internal manufacturer costs due to 
lighter periodic review  activities, as well as lower administrative costs associated with  liaison 
with third-country authorities where the device may also be registered, in order to inform them of 
the change. The saving calculated above is therefore likely to be an underestimate.  

Detailed analysis can be found in Annex IV - Table 10 

3.5.6.  Periodic Safety Update Reports (PSURs) 

Under the current framework, manufacturers of class IIa, IIb and III MDs and class C and D IVDs 
must prepare PSURs at fixed intervals and, for higher-risk devices, submit them to notified bodies 
for validation. The revision streamlines the PSUR requirements, introducing a more proportionate 
approach to reporting and review, based on device class, risk, and post-market experience.  

The targeted evaluation identified a need to streamline reporting requirements in the context of post-
market surveillance. 

To improve proportionality while maintaining the same level of safety oversight, the  proposal for 
revision is to: 

•  exclude custom-made devices from the PSUR requirement, recognising their individualised 

• 
• 

nature and low public health impact; 
remove the requirement for regular notified body evaluation of PSURs; 
reduce the fixed frequency of PSUR updates for class IIb and III devices and class C and D 
IVDs to every two years, instead of annually; 

23 

 
 
 
 
•  allow  class  IIa  implantable  device  manufacturers  to  update  PSURs  only  when  necessary, 

based on post-market data or identified trends. 

At  the  same  time,  notified  bodies  and  competent  authorities  may  continue  to  request  PSURs  or 
conduct targeted reviews were justified by vigilance data or market surveillance findings. 

This approach preserves the integrity of post-market safety monitoring while reducing duplication 
and  administrative  burden.  By  limiting  reporting  to  what  is  necessary  and  proportionate, 
manufacturers  are  expected  to  benefit  from  significant  cost  savings  and  reduced  administrative 
workload.  At  the  same  time,  the  removal  of  routine  notified  body  validation  for  certain  device 
categories would free up notified body resources, enabling them to focus on higher-risk areas and 
improving overall system efficiency.  

Cost savings:  

•  Based on extrapolation of data provided by notified bodies, around 15,700 medical device 
and 2,000 IVD PSURs can be expected after the transition to the Regulations is completed. 
Updating these PSURs on a yearly basis currently entails around €78,5 million for medical 
devices and €8,0 million for IVDs in notified body fees. Updating these PSURs on a yearly 
basis  currently  entails  manufacturer  internal  costs  of  around  €78,5  million  for  medical 
devices and €8,0 million for IVDs. 

•  Under the revised framework, removing the requirement for annual update for class IIa 
implantable  devices  and  reducing  the  frequency  of  mandatory  update  from  one  to  two 
years for the remaining devices would result in aggregate savings of about €53.7 million 
annually. 

•  The proposed measure also includes the requirement to update the PSUR when there is a 
significant change in the benefit-risk determination or in the acceptability of undesirable 
side-effects. This is not taken into account in the cost savings calculation as this type of 
update is already expected to take place today and would not change under the proposed 
revision.  

The calculation does not take into account the cost savings from the reduction in the frequency of 
notified  body  evaluations,  both  due  to  the  reduced  frequency  of  update  of  PSURs  by  the 
manufacturer  and  possible  reduced  frequency  of  annual  surveillance  activities  described  in 
section 3.5.2. 

Detailed analysis can be found in Annex IV - Table 11 

3.5.7.  Analysis of serious incidents 

The proposal for revision refines the vigilance process by clarifying the respective roles of competent 
authorities and notified bodies in the evaluation of serious incidents and field safety corrective actions 
under Articles 87 and 89 MDR and Articles 82 and 86 of the IVDR. Under current practice, notified 
bodies are often involved in incident assessments alongside competent authorities, which can lead to 
duplication of assessment, high costs and extended handling times. 

The  proposal  envisages  to  remove  the  systematic  requirement  for  notified  body  participation  and 
require  their  review  only  for  serious  incidents  linked  to  a  field  safety  corrective  action,  a  serious 
public health threat or where assistance is requested by the competent authorities.  

24 

 
 
 
These measures aim to streamline vigilance processes by reducing parallel evaluations and redundant 
correspondence between manufacturers, notified bodies, and national competent authorities. Notified 
bodies would only assess the most critical cases, reducing duplication with the work of the competent 
authorities. The authorities would still retain the possibility to request their assistance when needed. 
Therefore, this measure can be considered to keep the same level of patient safety, since all serious 
incidents would still be reviewed by the competent authorities and notified bodies would be involved 
in a proportionate manner. However, manufacturers would have less administrative burden and less 
cost to bear, since fewer formal submissions to notified bodies would be required. Moreover, notified 
bodies would save significant time and resources from reviewing fewer submissions.  

Cost savings: 

•  Based on data from national competent authorities about 144,000 serious incidents are 

reported per year across the Union market for medical devices and about 5,000 for IVDs.  

•  The current handling cost of a serious incident report by notified bodies is around €400 

per report. 

•  Removing the systematic requirements for notified body assessment would result in 
estimated annual cost savings of €50 million across medical devices and IVDs. 

The costs of notified body handling of serious incidents related to field safety corrective actions 
and serious public health threats are significantly higher. However, these activities are expected 
to continue, therefore their cost is not taken into account in this calculation.  

Detailed analysis can be found in Annex IV - Table 12 

Proposed measures – Part IIB 

3.6. 

 Simplification measures specific to certain devices  

3.6.1.  Well-Established Technologies (WET)  

The  revision  introduces  a  definition  of  WET  to  ensure  a  proportionate  application  of  regulatory 
requirements  for devices with  a proven record of safety  and performance. Rather than  relying on 
static  lists,  such  as  the  one  in  Article  52(4),  the concept  would  be  based  on  criteria  codified  in  a 
definition in Article 2. To maintain a high level of legal certainty, the Commission would retain the 
empowerment to draw up a non-exhaustive list of devices that should be considered to meet, or to 
not meet, the criteria of the new definition of WET devices. 

In the proposed revision, a device would qualify as a WET if it meets the following criteria:  it belongs 
to a generic device group with a simple, common and stable design, the generic device group is not 
associated with safety issues in the past, has well-known clinical performance characteristics and a 
long history on the Union market, and the device is a standard of care device with little evolution in 
indications and the state of the art. These strict criteria have been defined in line with the objectives 
of the Regulations to ensure a high level of protection of health for patients and users. 

Consequently, WET devices would benefit from targeted regulatory flexibilities, including: 

•  Exemption from implant-card obligations under Article 18 MDR; 
•  Simplified conformity assessment procedures under Article 52 MDR; 
•  Adapted clinical evidence requirements under Article 61 MDR. 

25 

 
 
The aim of these measures is to reduce unwarranted compliance burden for these devices, increase 
flexibility  by  introducing  an  adaptable,  criteria-driven  approach  and  have  the  option  to  further 
increase legal certainty via the empowerment for non-exhaustive lists of such devices. This set of 
measures would help focus regulatory oversight on higher-risk or novel technologies. By virtue of 
lightening the evidence generation and documentation obligations for WET devices, manufacturers 
would experience notable cost savings and decreased administrative burden. At the same time, the 
streamlined treatment of WET would allow notified bodies to reallocate capacity towards higher-risk 
or  innovative  technologies,  resulting  in  significant  time  savings  and  more  efficient  use  of  expert 
resources. Patients would ultimately benefit from lower costs and potentially greater variety of these 
devices available on the market as a consequence of lower regulatory hurdles for them.  

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.6.2.  Class I reusable medical device surgical instruments and class A sterile IVDs 

Under the current framework, notified bodies are involved for class I reusable surgical instruments 
(also referred to as class Ir devices) to assess aspects related to the cleaning, disinfection, sterilisation, 
maintenance,  and  functional  testing.  As  for  class  A  sterile  IVDs,  the  notified  body  involvement 
focuses on aspects related to sterility. 

To  improve  proportionality  of  the  regulatory  framework,  the  proposal  envisages  that  where 
manufacturers of class I reusable surgical instruments have applied harmonised standards or common 
specifications covering all relevant aspects of these requirements, the involvement of a notified body 
would no longer be necessary. The simplification is conditional on the availability of the harmonised 
standards or common specifications. Given that this is a relatively large group of products, it is likely 
that there would be significant interest in developing the standards or common specifications and that 
they would become available in a few years. The proposed simplification is therefore very likely to 
be applied in practice.  

For class A sterile IVDs, the intervention of a notified body is proposed to no longer be required, 
while  the  same  safety  and  performance  requirements  would  still  apply  to  the  manufacturer.  IVD 
sterility can be very important for generating correct results, however it is an established practice 
where standards are available. The risk is also not comparable to class I sterile medical devices which 
come into direct contact with the patient. Therefore, self-declaration by the manufacturer, a practice 
which  was  already  in  place  under  Directive  98/79/EC,  can  be  considered  appropriate  for  class  A 
sterile IVDs, in addition to vigilance and market surveillance generally applicable to all devices.  

For  both  class  I  reusable  surgical  instruments  and  class  A  sterile  IVDs,  the  proposal  reflects  the 
extensive standardisation and long-standing safe use of such instruments across healthcare settings 
and better aligns the level of regulatory oversight with the level of risk of these devices. It would 
reduce administrative burden and remove notified body fees for manufacturers, generating tangible 
cost savings for them, especially for SMEs as they tend to be more active in devices of lower risk 
classes. It would also free up notified body resources to focus on higher-risk devices. Similarly to 
WET devices, patients would benefit from lower costs and potentially greater variety of these devices 
available on the market as a consequence of lower regulatory burden for them. 

26 

 
Cost savings:  

•  The number of QMS certificates expected to cover class Ir devices after the transition to 
the Regulations is completed can be estimated to be about 700, and those covering class 
A sterile IVDs at about 24. Notified body fees for certification for these devices can be 
estimated at around €32,000. 

•  These fees would no longer be applicable in case of no  notified body involvement, for 
class Ir where harmonised standards or common specifications are applied. The resulting 
savings amount to approximately €22.5 million for class Ir devices and €767,000 for class 
A  sterile  devices.  Combined  across  both  categories,  the  total  average  saving  is  €23.3 
million. 

Detailed analysis can be found in Annex IV - Table 13 

3.6.3.  Technical documentation of near-patient tests 

The proposal for revision aims to simplify technical documentation assessment for near-patient tests. 
Near-patient tests are a small but important category of IVDs. They are performed by professional 
users but unlike other professional-use tests for which the patient specimen is sent to a laboratory, 
the  near-patient  tests  can  be  done  next  to  the  patient  or  in  the  clinic  where  the  patient  is  being 
examined.  Examples  include  rapid  antigen  infectious  agent  tests,  C-reactive  protein  tests,  blood 
coagulometers  or  urinalysis  dipsticks.  Currently,  they  are  subject  to  individual  technical 
documentation  assessment  regardless  of  the  class  they  fall  in.  However,  many  near-patient  test 
technologies  have  now  been  in  use  for  decades  and  benefit  from  mature,  standardised  and 
increasingly  automated  technologies,  and  are  operated  by  trained  healthcare  professionals  within 
controlled clinical environments.  

For the professional use tests the primary determinant of risk  can be considered to be the clinical 
impact of an incorrect result and the device’s inherent characteristics, rather than where the test is 
performed. Therefore, the revision proposes to treat them similar to other professional use devices of 
the same class as regards assessment of technical documentation. This means that near-patient tests 
falling in classes B and C would be subject to technical documentation assessment on a sampling 
basis. For class B near-patient tests only one device out of the manufacturer’s portfolio, and for class 
C near-patient tests one device out of a category of devices would be assessed by the notified body 
during initial certification. 

Cost savings: 

•  According to industry estimates of the number of near-patient tests on the EU market is 
around 150029. The majority of them is likely to have not yet transitioned to the IVDR as 
the transition deadlines for class C and B devices are in 2026 and 2027 respectively.  
•  Using typical notified body fees for technical documentation assessment, the cost saving 
for these devices moving from a comprehensive to a sampling-based approach would be 
around €68 million.  

29 MedTech Europe, Survey Report analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in May 2022 when the 
new EU IVD Regulation applies, September 2021. 

27 

 
 
 
 
 
 
• 

In addition to this one-off cost, assuming that around 5% new near-patient tests would be 
coming  on  the  market,  a  yearly  saving  of  €3.4  million  can  be  expected  only  from  the 
simplification related to the initial certification. 

This  does  not  take  into  account  additional  savings  expected  from  the  internal  costs  of  the 
manufacturer related to the notified body’s assessment. It also does not take into account further 
savings expected from reduction in annual surveillance of the technical documentation certificates. 
Therefore, the above saving is likely to be an underestimate.  

Healthcare is becoming increasingly decentralised and personalised, and technology development 
enables more portability and faster results with similar performance to laboratory-based tests. As 
the availability and use of near-patient tests grow, the associated cost savings generated by a more 
proportionate regulatory approach would also increase, amplifying the overall benefit for health 
systems.  

Detailed analysis can be found in Annex IV - Table 14 

3.6.4.  In-house devices 

The  revision  introduces  targeted  flexibilities  for  devices  manufactured  and  used  within  health 
institutions under Article 5(5) of the Regulations (so-called in-house devices).  

Under the current framework, health institutions must meet certain documentation and justification 
requirements.  Health  institutions  have  reported  that  these  new  obligations  are  burdensome, 
particularly  for  public  hospitals  and  diagnostic  laboratories  operating  under  accredited  quality 
systems,  often  leading  to  repetitive  paperwork  and  shifting  staff  time  from  clinical  or  diagnostic 
activities. Moreover, the high burden and notably the need to justify that that the target patient group's 
specific  needs  cannot  be  met,  or  cannot  be  met  at  the  appropriate  level  of  performance  by  an 
equivalent  device  available  on  the  market  discourages  health  institutions  from  investing  into  the 
development  of  in-house  devices  with  adverse  effects  both  for  the  needs  of  patients  and  for  the 
preparedness for crises and emergency situations (such as during the COVID-19 pandemic). 

To  improve  proportionality  and  reflect  the  special  nature  of  in-house  device  manufacturing,  the 
proposal introduces the following simplifications:  

• 

• 

transferability: allow the transfer of in-house devices between health institutions, provided 
that there is duly justified interest of public health or patient safety or health; 
justification  for  absence  of  equivalent  CE-marked  devices:  introduce  a  10-year  transition 
period for health institutions to adopt a suitable equivalent  CE-marked device once such a 
product becomes available for medical devices, and remove this condition for IVDs, for which 
it is considered particularly burdensome; 

•  accredited laboratories (IVDR): where a health institution is accredited under ISO 15189, the 
requirement to draw up full documentation demonstrating compliance with Annex I (general 
safety and performance requirements) is proposed to be waived, recognising that accreditation 
already ensures a comparable level of quality control and traceability. 

These simplifications would benefit health institutions by reducing the costs and time required for 
compliance and allowing them to invest resources into treating patients rather than administrative 
tasks. They would also benefit patients, in particular those suffering from rare conditions for which 
commercial devices are not available, as health institutions would be better able to satisfy their needs. 

28 

 
 
 Cost savings:  

•  Setting  up and maintaining an  Article 5(5)  compliant  system  typically requires  substantial 
investment by health institutions, including a significant time investment and initial system-
establishment costs of approximately €176,000 for medical devices and €200,000 for IVDs, 
and recurring annual maintenance and staff needs amounting to €42,000 for medical devices 
and €34,000 for IVD. In case of possibility to transfer the in-house device for use in another 
health institution, the receiving health institution would not have to incur these costs. 

•  The  10-year  transition  period,  or  removal  of  the  justification  condition,  allows  health 
institutions  to  continue  using  in-house  devices  when  an  equivalent  CE-marked  alternative 
becomes available, avoiding immediate replacement.  

o  This means that the above costs incurred by the health institution for the development 
of the manufacturing system, plus additional costs to create the documentation of the 
in-house device, would not be rendered obsolete.  

o  The extended transition period or removal of the condition would also provide more 
time  for  market  competition  to  drive  down  prices  and  improve  performance  of  the 
alternative  CE-marked  devices.  Health  institutions  report  that  CE-marked  devices 
currently replacing in-house devices can be about 5 times more expensive, and they 
can have higher running costs, which the health institution is currently obliged to bear. 
Moreover, their performance may not be superior to the in-house device, making the 
costs of changeover difficult to justify. With a longer transition time, these negative 
consequences  of  an  obligatory  immediate  switch  to  the  first  available  CE-marked 
device can be mitigated. 

o  Thirdly, the proposal would preserve the incentive for health institutions to develop 
in-house  devices,  therefore  better  addressing  the  needs  of  patients  and  developing 
expertise and infrastructure essential for crisis response. 

•  For  IVDs,  accredited  laboratories  operating  under  ISO  15189  would  benefit  from  an 
exemption  from  the  device  documentation,  avoiding  substantial  documentation  and 
justification  requirements.  Health 
technical 
documentation in addition to what is already required by ISO 15189 can range from 5 to 1,000 
pages and demand between 8 and 2,880 hours, with the corresponding cost ranging from 
€400 to €140,000. This illustrates the significant administrative burden that could be avoided 
for these accredited institutions under the revised framework. 

institutions  report 

that  preparing 

the 

•  The number of in-house devices and health institutions across the EU is difficult to estimate 
as there is no universal requirement to notify them. Member State policy towards in-house 
devices can also vary, so they can be more widespread in some Member States compared to 
others.  Belgium  has  a  publicly  available  portal  where  health  institutions  need  to  register 
themselves and their devices and currently has 43 registered health institutions and a total of 
around 1600 in-house devices. However, some institutions have not registered any devices 
yet, so this number is likely to be an underestimate. A study of one university hospital shows 
that one health institution can have as many as 500 in-house devices (Vermeersch P, Van Aelst 
T,  Dequeker  EMC.  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. Clin Chem Lab 
Med. 2020 Jul 21;59(1):101-106. doi: 10.1515/cclm-2020-0804. PMID: 32692695). This is 
likely  to  be  an  overestimate  compared  to  the  EU-wide  average  as  this  is  a  large  health 
institution. All in all, the number of in-house devices across the EU is likely to be in the tens 
to hundreds of thousands, used in several thousands of health institutions. The savings from 
the above simplifications are therefore likely to be significant.  

29 

 
 
3.6.5. 

Orphan and Breakthrough Devices 

The proposal for revision introduces a dedicated regulatory pathway for  orphan and breakthrough 
medical devices and IVDs. Under the current framework, there are no specific provisions to facilitate 
the assessment or market entry of devices addressing rare conditions or introducing high levels of 
technological or clinical innovation. This has led to fragmented treatment of such devices and longer 
time-to-market  compared  to  jurisdictions  with  dedicated  programmes,  delaying  patient  access  to 
technologies with potentially transformative impact on health outcomes and healthcare systems. 

Breakthrough and orphan devices often originate from start-ups, SMEs, and academic innovators, 
which face significant challenges in generating extensive pre-market evidence despite the potential 
of their technologies to deliver substantial clinical or public-health benefits. Many of these devices 
target unmet medical needs, including rare diseases or life-threatening conditions with limited or no 
existing alternatives, where small patient populations make evidence generation costly and complex, 
amplifying the burden on manufacturers with low sales volumes. 

The  proposed  new  framework  establishes  eligibility  criteria  for  designation  as  a  breakthrough  or 
orphan device, supported by an expert panel opinion. Through the empowerment for an implementing 
act, it aims to further introduce prioritised and rolling review during conformity assessment and allow 
for conditional certification where benefits of early access outweigh residual uncertainty, provided 
that additional clinical data are collected post-market. This approach reduces the regulatory burden 
and  associated  costs  for  developers  while  enabling  earlier  access  to  promising  technologies  for 
patients with urgent or rare conditions. Thus, the proposed framework would contribute to the general 
objective of the Regulations to ensure a high level of protection of health for patients and users. This 
measure aligns the EU framework with international best practices and provides a more predictable 
route for innovative developers while safeguarding patient safety, ultimately accelerating access to 
breakthrough innovation and supporting healthcare systems in addressing unmet medical needs more 
efficiently.  

Cost savings:  

The numbers of both orphan and breakthrough devices are likely to be small, due to their special 
nature, but the cost savings a manufacturer of either device type can be significant.  The main 
benefit from the policy would be for patients who would gain faster access to these devices which 
could be essential for them. It is particularly difficult to estimate the number of orphan devices, 
to quantify savings during conformity assessment for both types of devices and to quantify the 
impact  on  patients.  The  below  cost  savings  analysis  focuses  on  quantifying  opportunity-cost 
savings for breakthrough devices due to expected shorter time-to-market.   

•  Prioritised assessment of breakthrough devices could shorten certification timelines by at 
least 3 months, accelerating access to market. Considering different scenarios of device 
complexity, price and volumes sold, estimated average opportunity-cost savings from the 
earlier market access possibility are at €1,500-4,500 per device.  

•  Assuming that 80 breakthrough devices are certified out of an estimated 165 designated 
per year (based on data from comparable market data from US FDA), this could result in 
estimated cost savings of around €570 million per year.  

This calculation considers only one aspect of savings from the described measures, as explained 
above. Therefore, this amount is an underestimate.  

Detailed analysis can be found in Annex IV - Table 15 

30 

 
3.6.6.  Grandfathering of Orphan Medical Devices and IVDs Already on the Market 

The proposal for revision introduces a derogation mechanism allowing certain legacy devices that 
qualify as orphan devices to remain on the market beyond the current transitional deadlines. This 
measure  addresses  situations  where  withdrawal  of  such  devices  could  leave  patients  with  rare 
diseases without suitable alternatives, as the costs of compliance are too high for the manufacturers 
of such devices. The proposal would therefore help ensure continued access to essential technologies 
while avoiding unnecessary regulatory and financial burdens for manufacturers. 

According to the proposal, devices that meet the orphan device criteria, as confirmed by an expert 
panel, may continue to be placed on the market or put into service, provided that they: 

•  continue to comply with the essential requirements of the Directives30; 
•  have not undergone significant changes in design or intended purpose; and 
•  do not present any unacceptable risk to patients, users, or public health. 

These  devices  would  not  bear  the  CE  marking  but  must  include  a  clear  statement  in  the  EU 
declaration of conformity and associated documentation indicating that they are placed on the market 
under this specific derogation. Manufacturers remain subject to the Regulations’ provisions on post-
market  surveillance  and  vigilance,  including  annual  PSUR  submission  and,  where  required,  post-
market clinical follow-up. The post-market oversight of these devices is proposed to be ensured by 
the  national  competent  authorities.  This  measure  would  significantly  reduce  manufacturers’ 
compliance costs, save notified bodies’ resources that would otherwise  be spent reassessing long-
established low-volume orphan devices, while safeguarding patients’ continued access to essential 
treatments  and  avoiding  unnecessary  shortages.  National  authorities  would  need  to  carry  out 
additional  post-market  monitoring  activities  for  these  devices;  however,  this  workload  remains 
significantly  lower  than  the  full  conformity  assessment  that  would  otherwise  be  required  from  a 
notified body. Given that the number of such devices is expected to remain limited, the additional 
effort  for  national  authorities  is  likely  to  be  outweighed  by  the  benefits  described  above,  most 
importantly the continued availability of these devices for patients.  

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

30 Council Directive 93/42/EEC (MDD) on medical devices, Council Directive 90/385/EEC on active implantable medical device and 
Directive 98/79/EC on in vitro diagnostic medical devices. 

31 

 
 
3.6.7.  Fee reductions 

The proposal for revision introduces fee reductions to ensure a more proportionate and equitable cost 
structure, particularly for smaller economic operators and for manufacturers of orphan devices. Under 
this new proposed provision, notified bodies would be required to apply at least a 50% fee reduction 
for micro-enterprises and at least 25% fee reduction for small enterprises, as well as at least 50% 
reduction for conformity assessment of orphan devices. This measure promotes a level playing field 
for micro and small companies, supports early-stage innovators, and ensures that cost considerations 
do not hinder the development or maintenance of devices addressing rare diseases.  Overall, these 
measures  would  ease  the  financial  burden  on  micro  and  small  companies,  while  also  sustaining 
continued  availability  of  devices  serving  very  small  patient  populations  and  supporting  overall 
system resilience. 

Cost savings:  

This  calculation  is  focusing  on  the  fee  reductions  for  micro  and  small  enterprises.  The  fee 
reductions for orphan devices would make a further contribution, however it is challenging to 
estimate  due  to  lack  of  quantitative  data  on  the  number  of  orphan  devices.  The  number  of 
applications from manufacturers of orphan devices per year is expected to be small.   

•  Across MDR and IVDR, notified bodies can be expected to receive approximately 834 
applications  per  year  from  micro-enterprises  and  1,428  from  small  enterprises, 
considering both applications for new certificates and for changes to existing certificates. 
•  Under the revised provisions, notified bodies must apply at least a 50% fee reduction for 
micro-enterprises and 25% for small enterprises. Application of these factors to the annual 
application volumes in both medical devices and IVD, taking into account different costs 
of conformity assessment for different risk classes, results in a total estimated saving for 
these manufacturers of €90 million per year. 

Detailed analysis can be found in Annex IV - Table 16 

3.6.8.  Companion diagnostic (CDx) consultation 

Currently  the  IVDR  requires  a  consultation  of  the  medicinal  products  authority  (in  practice  most 
frequently the European Medicines Agency (EMA)) on the suitability of the companion diagnostic 
in relation to the medicinal product. The proposal simplifies the scope of the consultation by limiting 
it  to  the  suitability  of  clinical  performance  only.  It  also  clarifies  that  this  consultation  should  not 
duplicate the assessment of the notified body, which would fully assess all aspects of the device in 
accordance with the IVDR. Moreover, devices that have the same intended purpose and performance 
as  another  device  that  already  underwent  the  consultation  are  proposed  to  be  exempt  from  the 
consultation requirement.  

Cost savings: 

•  The current consultation cost of the EMA is €56,500, with an additional €5,000 charged 
for assessment of changes to the device. The proposed simplifications should result in both 
the reduction of the fee per consultation and the frequency of the consultation. Moreover, 
there  would  also  be  significant  savings  of  costs  internal  to  the  manufacturer  and  to  the 

32 

 
 
 
 
 
notified  body  linked  to  the  interaction  with  the  medicinal  product  authority,  as  well  as 
resource savings at the EMA and the national competent authorities for medicinal products.  

3.6.9.  CDx – association of similar medicinal products  

Currently, the IVDR requires that the International Nonproprietary Name(s) (INNs) of the associated 
medicinal  product  must  be  indicated  in  the  intended  purpose  of  the  device  and  associated 
documentation of a CDx IVD. Adding a new medicinal product to the intended purpose of a CDx is 
currently considered by the notified bodies as requiring a new conformity assessment, regardless of 
whether the new medicinal product is similar to those already covered or different31. This revision 
introduces  a  targeted  simplification  for  CDx,  namely  giving  the  manufacturers  a  possibility  to 
reference a group of medicinal products with common characteristics in the intended purpose and 
associated documentation instead of individually specifying the INNs. The evidence requirements 
remain  unchanged,  i.e.  manufacturers  would  still  need  to  justify  that  their  clinical  evidence  is 
sufficiently  broad  to  support  the  use  of  the  CDx  with  the  medicinal  products  in  the  group.  This 
justification  would  still  be  reviewed  by  the  notified  body  and  the  CDx  would  be  subject  to  a 
consultation  of the medicinal product  authorities (unless  it is  covered by the simplification in  the 
previous section). Therefore, the measure does not affect the safety of the patients. However, it does 
reduce  the  administrative  burden  associated  with  repeated  updates,  for  example  when  a  new 
medicinal product with the same mechanism of action and indications is approved and can be safely 
paired with an existing CDx. By avoiding multiple repetitive dossier revisions and consultations of 
the medicinal product authorities, the measure delivers cost and time savings for manufacturers and 
reduces the burden on notified bodies and the medicinal product authorities, while maintaining an 
appropriate level of oversight of these devices. 

Cost savings:  

•  Based  on  current  data  from  the  study  on  monitoring  the  medical  device  market,  and 
information available on CDx on the US market, a conservative estimate of the number 
of CDx on the EU market once the transition to the IVDR is completed is around 70. It 
can be assumed that the addition of similar medicinal products occurs around every two 
years, which currently trigger conformity assessment costs around €75,000 and current 
medicinal  product  authority  consultation  costs  of  €56,500,  as  they  are  considered  to 
require a new conformity assessment and a new consultation. 

•  Allowing to reference to a group of medicinal products in the description of CDx intended 
purpose  would  reduce  the  burden  related  to  these  updates.  Applied  to  the  above  CDx 
volume, this simplification yields an estimated Union-wide cost saving of €5.5 million 
per year.  

Given  that  the  CDx  market  is  likely  to  grow  in  the  future  with  the  greater  trends  towards 
personalised medicine, these savings could be even higher.   

Detailed analysis can be found in Annex IV - Table 17 

31 Team-NB website, Team-NB Position Paper. 

Detailed analysis can be found in Annex IV - Table 17 

33 

Detailed analysis can be found in Annex IV - Table 17 

 
 
 
 
 
 
 
 
 
PART III – CROSS-CUTTING SIMPLIFICATION, STREAMLINING PROCESSES AND HARMONISATION OF 
ACTIVITIES 

Proposed measures 

3.7. 

 Support mechanisms  

3.7.1.  Qualification and Classification  

The  new  proposed  provisions  introduce  a  coordinated  process  among  competent  authorities, 
supported  where  necessary  by  expert  panel  opinions,  to  determine  whether  a  specific  product  or 
product group falls within the scope of the MDR or IVDR. The new formal advisory mechanism 
would  allow  competent  authorities,  notified  bodies,  developers  or  the  European  Commission  to 
request  expert  panel  advice  on  a  product’s  regulatory  status  and  proposed  classification.  The 
framework also establishes structured consultation channels between Member States and with other 
EU  regulatory  agencies  (e.g.  EMA,  ECHA,  EFSA  and  the  SoHO  Coordination  Board)  to  ensure 
coherence  across  related  legislative  frameworks  and  to  avoid  conflicting  regulatory  outcomes. 
Moreover,  the  Commission  may  adopt  legally  binding  implementing  acts  to  ensure  uniform 
qualification decisions across the Union.  

This coordinated Union-level mechanism allows different types of actor to benefit from the scientific 
and technical expertise available in the expert panels, reduces duplication of work among Member 
States,  and  avoids  divergent  national  interpretations,  ultimately  leading  to  more  legal  clarity, 
smoother operation of the single market and faster and less costly access of devices to market. 

The proposal for revision also introduces a structured process for Member State competent authority 
resolution  of  classification  disputes  between  manufacturers  and  notified  bodies.  It  includes 
consultation of other Member States and consultation of an expert panel in cases of disagreement 
between them.    

For both qualification and classification, decisions of the Member State competent authorities and 
opinions  of  the  expert  panel  would  be  published,  increasing  transparency  and  predictability  for 
stakeholders. 

This  approach  ensures  a  more  uniform  application  of  qualification  and  classification  rules  across 
Member States. Manufacturers and innovators, particularly SMEs, would benefit from earlier clarity, 
fewer disputes and discussions with notified bodies and competent authorities, resulting in devices 
reaching the market faster, and a more level playing field with other manufacturers. 

Notified bodies would also gain efficiency from greater clarity, have more consistent expectations 
from manufacturers and more harmonised practices among each other, allowing them to use their 
resources more efficiently. 

Member  State  authorities  would  also  make  more  efficient  use  of  their  resources  through  this 
streamlined process and increased transparency of decisions already taken. 

Patients  would  benefit  from  devices  being  available  on  the  market  sooner,  in  particular  more 
innovative devices which typically bring qualification or classification challenges. 

By  establishing  a  single,  coherent,  and  predictable  Union-level  mechanism  for  qualification  and 
classification, the revision enhances legal certainty, accelerates market access, reduces repetitive or 
parallel  assessment  across  Member  States  and  notified  bodies,  and  reinforces  the  uniform 

34 

 
implementation of the Regulations. The strengthened coordination mechanisms ensure that decisions 
are  evidence-based,  transparent,  and  consistently  applied,  thereby  supporting  a  more  coherent 
regulatory environment for manufacturers and authorities alike. 

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability. 

3.7.2.  Dispute resolution 

The  current  regulatory  framework  does  not  provide  a  structured  procedure  for  resolving 
disagreements  arising  from  during  conformity  assessment,  such  as  divergent  interpretations  of 
requirements by the manufacturer and the notified body. In the absence of such a mechanism, disputes 
are  handled  bilaterally  between  notified  bodies  and  manufacturers  or  escalated  through  litigation, 
leading to prolonged uncertainty and inefficient use of resources. 

The proposed measure introduces a framework allowing manufacturers or notified bodies to raise 
substantiated  disputes  before  the  authority  responsible  for  the  notified  body.  The  authority  may 
examine  the  case,  seek  clarifications,  or  request  further  input  from  the  notified  body  and  other 
relevant  actors.  Where  the  manufacturer  is  established  in  another  Member  State  than  the  notified 
body,  the  authority  responsible  for  the  notified  body  must  consult  the  competent  authority  of  the 
Member State where the manufacturer is established.  In duly justified cases, the authority responsible 
for  notified  bodies  may  seek  guidance  from  the  MDCG.  By  providing  a  structured  avenue  for 
resolving  disagreements,  the  revision  enhances  predictability  and  legal  certainty,  offering 
stakeholders a more reliable basis for planning and compliance. It is expected to generate efficiency 
gains for manufacturers and notified bodies by limiting prolonged exchanges, appeals, and associated 
costs, thereby enabling disputes to be settled more swiftly and with fewer administrative burdens. 

This  mechanism  also  supports  a  more  aligned  and  consistent  approach  across  notified  bodies, 
reducing the risk of contradictory interpretations and contributing to more proportionate and balanced 
application of regulatory requirements. 

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.7.3.  Early advice to manufacturers and structured dialogue with notified bodies  

Article  61(2)  of  the  MDR  currently  allows  manufacturers  of  class  IIb  devices  administering  a 
medicinal  product  and  of  class  III  devices  to  consult  expert  panels  on  their  clinical  development 
strategy. In practice, however, use of this early advice mechanism has been limited and perceived as 
disconnected from notified body expectations, which reduces its practical value to manufacturers. 

To address these shortcomings, the proposal for revision expands this consultation mechanism into a 
joint scientific, technical and regulatory advice procedure, where the manufacturer would be able to 
request  advice  from  a  panel  consisting  of  both  scientific  and  technical  experts  and  experts  from 
notified bodies, clarifying expectations also from the conformity assessment perspective. The scope 
of the procedure is also proposed to be expanded to class IIb or III medical devices and class C or D 
IVDs.   

The expanded early advice would further support manufacturers by giving them broader access to 
advice from experts and enhance the relevance of the advice by including not only the scientific and 

35 

 
technical but also regulatory perspective. The clinical strategy is one of the most costly and time-
consuming aspects of the manufacturer’s conformity assessment work. Being able to obtain advice 
on  this  early  on  and  including  also  the  regulatory  component  offers  significant  benefits  to  the 
manufacturer,  avoiding  potential  significant  delays  and rework  for months  or even years in  cases 
where the clinical strategy would otherwise be later questioned by the notified body.  

Notified bodies would also benefit from this procedure.  The advice would be given by experts in 
their individual capacity and not on behalf of the notified bodies, preserving the independence of the 
notified  bodies.  Nevertheless,  by  participating  in  the  panel,  the  notified  body  experts  would  gain 
exposure  to  state-of-the-art  developments,  benefit  from  peer  exchange  and  cross-fertilisation  of 
expertise in the panel and enhance their broader competence in assessing similar types of devices in 
the  future.  The  expanded  early  advice  mechanism  would  therefore  support  a  more  informed  and 
efficient notified body assessment environment.  

Considering the regulatory framework as a whole, the greater use of clinical, technical and regulatory 
expertise available across the sector would support the gradual convergence of expert views on what 
constitutes an appropriate clinical strategy and appropriate clinical evidence, contributing to greater 
harmonisation  of  approaches  among  manufacturers  and  notified  bodies  without  compromising 
notified body independence in individual assessments.  

In parallel, the revision aims to formalise and expand the concept of a structured dialogue between 
manufacturers and notified bodies before and during conformity assessment, by requiring notified 
bodies to have procedures in place for this. Structured dialogue is a tool intended to be used later in 
the conformity assessment process compared to the early advice described above. Its objective is to 
help manufacturer prepare a good quality application for conformity assessment to be submitted to 
the notified body. 

Currently, notified bodies report that applications from manufacturers are frequently incomplete32, 
and it is common practice for documentation to go through several cycles of revision by the notified 
body, which is costly and time-consuming. Structured dialogue between manufacturers and notified 
bodies is currently already being implemented but in a limited and ad hoc manner in the absence of 
a clear legal basis. The greater use of structured dialogue under the proposed revision would provide 
manufacturers with a systematic opportunity to clarify expectations regarding their application and 
to address issues proactively before formal submission. This is expected to increase the quality of the 
application and reduce the number of rounds of assessment.  

These measures directly respond to stakeholder feedback highlighting that fragmented or late-stage 
interactions  with  notified  bodies  often  lead  to  uncertainty,  repetitive  reviews,  and  prolonged 
certification timelines. By providing more possibilities for advice at an early stage, with an integrated 
regulatory  perspective,  and  a  predictable  dialogue  process  with  the  notified  bodies,  the  measures 
would  help  ensure  good  quality  of  manufacturers’  applications  and  a  smooth,  efficient  and 
predictable  conformity  assessment  framework.  This  is  expected  to  translate  into  faster  and  more 
efficient market access of devices, with significant cost reductions for manufacturers. The measures 
are  expected  to  particularly  benefit  SMEs,  which  tend  to  have  limited  resources  and  need  more 
support to navigate the regulatory framework. Notified bodies would also benefit from participating 
in the advice process as described above and be able to use their resources more efficiently due to 

32 GÖG et al. (2022–2025) 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. Data extracted from February 2025. 

36 

 
 
improved  quality  of  submissions.  Patients  would  ultimately  benefit  from  greater  availability  of 
devices on the EU market.  

Cost savings: 

•  The  frequency  of  manufacturers’  recourse  to  early  advice  and  the  savings  they  may 
experience  can  vary.  Therefore,  several  scenarios  were  considered.  A  base  number  of 
5,500 annual clinical evidence packages was used, of which the majority would be for 
changes to existing devices and a smaller part for new devices. Assuming that for 50% 
of new packages and 10% of modified packages the manufacturers would make use of 
the early advice, that certain proportions of them would benefit from minor, moderate or 
major savings, and applying a factor to take into account fees for the early advice, annual 
total savings of €84.5 million can be expected. A more conservative scenario with 30% 
of new packages and 5% of modified packages making use of the early advice delivers a 
saving of €46.2 million per year. 

•  For  structured  dialogue,  modelled  across  5,500  annual  applications  to  notified  bodies, 
higher rate of recourse can be anticipated. With all applications for new devices and 10% 
of applications for changes using structured dialogue, the measure yields €101.3 million 
in annual savings. A conservative alternative with 80% of applications for new devices 
and 5% of applications for changes using structured dialogue, savings of €70 million per 
year can be estimated. 

This  calculation  uses  rather  conservative  saving  rates  of  between  €40,000  and  €250,000  per 
intervention. In reality the costs of e.g. re-doing a clinical investigation can exceed €1 million. 
Therefore, some  manufacturer savings would be  significantly higher than the above  estimate. 
Overall,  several  factors  could  either  increase  or  decrease  the  final  savings,  so  the  figures 
presented should be seen as indicative rather than definitive. 

Detailed analysis can be found in Annex IV - Table 18 

3.7.4.  Regulatory sandboxes 

The proposal for introduction of regulatory sandboxes at both national and Union level. At national 
level, the sandboxes would create new possibilities for controlled development, testing and validation 
of innovative medical technologies under real-world conditions. At Union level, sandboxes would 
additionally enable the testing alternative regulatory approaches or practices, supporting a forward-
looking  assessment  of  whether  existing  rules  remain  appropriate  for  emerging  technologies  and 
alignment with regulatory science. 

These mechanisms would offer several benefits for innovation and public health. By enabling early, 
supervised  experimentation,  sandboxes  would  help  accelerate  responsible  development  while 
ensuring that high levels of patient safety and public health protection are maintained through tailored 
risk-control measures. At the same time, the structured evaluation of regulatory adaptations would 
support more agile policymaking, help identify potential gaps or bottlenecks in current requirements 
and provide evidence to inform future regulatory improvements. Importantly, Union-level sandboxes 
would not permit the placing on the market of non-compliant devices, ensuring that experimentation 
occurs without compromising patient safety or health. 

A  range  of  actors  would  be  able  to  participate  in  or  contribute  to  sandbox  activities,  including 
manufacturers, notified bodies, healthcare professionals, and other relevant stakeholders. National 

37 

 
 
 
 
 
 
competent  authorities  would  supervise  the  implementation  of  national  sandboxes,  while  the 
Commission oversees Union-level initiatives. Expert panels are proposed to play a central advisory 
role  in  the  design  of  sandbox  plans,  ensuring  appropriate  scientific,  technical  and  regulatory 
guidance. Both Member States and the Commission would be required to keep the Medical Device 
Coordination Group informed of sandbox establishment and outcomes, helping foster transparency, 
learning across jurisdictions, and the potential development of multi-country sandboxes in the future. 

Overall, the measure aims to make the EU more agile in addressing the regulatory needs of novel 
device types, facilitating faster or, in some cases, enabling market access for safe novel technologies 
and strengthening competitiveness of EU innovators. 

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.7.5.  EMA support scheme to SMEs  

The proposed revision introduces an EU-level support scheme to be set up by the EMA in order to 
strengthen the ability of small and medium-sized enterprises to navigate the medical device and IVD 
regulatory framework. Many SMEs face structural challenges such as limited regulatory capacity and 
have particular challenges dealing with complex systems and high volumes of regulatory information. 
This measure is intended to provide targeted support and access to regulatory knowledge specifically 
for SMEs. 

By  improving  SMEs’  understanding  of  regulatory  requirements,  the  measure  reduces  avoidable 
errors,  lowers  compliance-related  costs,  and  helps  ensure  a  more  even  playing  field  with  larger 
manufacturers. This support is expected to facilitate faster and smoother market access for SMEs, 
reduce redesigns and repeated submissions, and generate significant cost savings.  

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.8. 

 Efficiency of notified body designation and monitoring  

The proposal for revision introduces a set of targeted measures to improve the efficiency, coherence, 
and  predictability  of  the  oversight  system  for  notified  bodies.  These  measures  address  both  the 
designation and monitoring of notified bodies, aiming to optimise the use of administrative resources 
while maintaining a high and uniform level of competence and performance across the Union. By 
reinforcing  coordination  structures,  the  revised  framework  also  strengthens  mutual  learning  and 
supports  a  more  consistent  application  of  requirements  across  authorities,  thereby  facilitating 
smoother  interactions  between  notified  bodies  and  manufacturers  and  contributing  to  more 
proportionate and predictable implementation. 

For the  designation  process,  the authority  responsible for notified bodies  would  become a  formal 
member of the Joint Assessment Team (JAT) besides experts from other Member States and experts 
nominated by the Commission, to streamline the process and foster harmonisation among the actors 
involved.  This  enhances  mutual  understanding  and  improves  the  consistency  of  assessments, 
minimising unnecessary duplication of work and communications. As a result, Member States can 
develop more harmonized expertise and practices, which would, in turn, lead to a more consistent 
approach among notified bodies and stable expectations for manufacturers. 

38 

 
The proposal for revision strengthens coordination mechanisms between the authorities responsible 
for notified bodies, including structured exchanges to resolve diverging opinions on the assessment 
of notified bodies, thus aiming to ensure a uniform level of rigour and reduce procedural delays in 
reaching consensus. 

The monitoring of notified bodies would similarly benefit from enhanced cooperation. JATs would 
participate in periodic monitoring at least every two years, supporting early identification of systemic 
issues and promoting harmonised practices across the Union. Monitoring activities would be planned 
based  on  the  activities  of  the  individual  notified  body  and  customised  ensuring  the  continuous 
compliance is properly verified.   

The replacement of the current obligation for full five-year reassessments of all notified bodies with 
a strengthen central monitoring mechanism would allow authorities and joint assessment teams to 
focus resources on targeted and “for-cause” reviews, while ensuring full notified bodies compliance 
is verified. This contributes to a more efficient use of resources authorities and notified bodies and 
lower administrative costs. 

Overall,  the  proposed  measures  aim  to  reinforce  coordination  and  communication  between 
designating  authorities,  notified  bodies,  and  the  Commission.  This  would  enhance  harmonisation 
across Member State designating authorities and downstream alignment of notified bodies’ practices, 
contributing to a more predictable regulatory environment. 

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.9. 

 Internationalisation and competitiveness  

Stakeholders  underline  that  while  the  medical  device  market  is  increasingly  global,  there  are 
differences between regulatory requirements of the EU and other major jurisdictions. This means that 
EU  manufacturers  must  often  undergo  separate  processes  (depending  on  notified  body  practices) 
under other schemes or lengthier combined processes, reducing the competitiveness of the EU as a 
base for innovation. In this context, strengthening international regulatory cooperation and alignment 
becomes essential not only to facilitate global market access but also to  generate cost savings for 
manufacturers  by  reducing  multiplicity  of  processes.  The  proposal  for  revision  strengthens 
international  regulatory  cooperation  and  alignment,  allowing  the  Union  to  participate  more 
effectively in global harmonisation fora such as the IMDRF, enhancing the EU’s strategic position 
in  global  regulatory  cooperation.  It  also  empowers  the  Commission  to  conclude  administrative 
arrangements  and  develop  implementing  acts  to  operationalise  reliance  mechanisms  such  as  the 
MDSAP. 

Participation in international reliance schemes, in which the EU requirements are taken into account, 
would  bring  cost  and  time  savings  for  manufacturers  placing  devices  on  the  market  in  several 
jurisdictions and improve efficiency, predictability, and competitiveness without lowering safety or 
performance  requirements. Notified  bodies  would  also  benefit,  as  reliance  reduces  the  need  for 
parallel  or  overlapping  assessments,  duplicative  reporting  and  frees  resources  for  additional 
assessments and higher-risk products, thereby reducing certification time and possible bottlenecks. 
Patients would benefit from earlier availability of devices on the Union market.  

39 

 
Cost savings:  

This  calculation  focuses  on  cost  savings  for  manufacturers  interested  in  using  the  MDSAP. 
According to the proposed measures MDR / IVDR requirements could be integrated in MDSAP 
programme.  This  would  allow  manufacturers  to  undergo  only  MDSAP  process,  including  a 
single MDSAP audit, instead of a combined MDSAP+MDR/IVDR audit, receiving a single audit 
report and having one single scheme to follow to address findings.   

•  The  number  of  EU  manufacturers  interested  in  benefiting  from  MDSAP  reliance 
varies by enterprise size, ranging from 5% of micro-enterprises to 100% of large and 
very large manufacturers. Out of about 15,400 notified body clients, the total number 
estimated to be interested in using MDSAP is about 5,800 manufacturers.  

•  Estimated cost savings per avoided MDR/IVDR and MDSAP combined approach are 
on average around €16,000. This reduction stems from avoided duplicative processes, 
reduced preparation and follow-up costs, and decreased documentation and internal 
resource effort.  

• 

 Combining these elements yields average savings of €92.2 million per year. 

In addition to direct audit-related savings, with greater use of MDSAP, EU manufacturers would 
also avoid substantial opportunity costs from longer conformity assessment times associated with 
undergoing separate or combined audits processes to access non-EU markets, and consequent 
postponing  or  slowing  planned  expansion  into  additional  jurisdictions.  Therefore,  the  above 
savings calculation is likely to be an underestimate. 

Detailed analysis can be found in Annex IV - Table 19 

3.10. 

 Other actions to streamline compliance 

3.10.1. Supply chain monitoring  

The revision of Article 10a of the Regulations reinforces EU’s capacity to anticipate and manage 
medical device supply disruptions.  The new provision strengthens the EU’s ability to anticipate and 
manage shortages of medical devices that could seriously affect patient care. It requires the EMA to 
set up or further develop an EU-wide IT system dedicated to reporting and exchanging information 
on  interruptions  or  discontinuations  in  the  supply  of  medical  devices.  This  system  would  be 
interoperable with EUDAMED and would also allow hospitals and healthcare professionals to report 
situations  in  which  a  device  is  unavailable  or  at  immediate  risk  of  becoming  unavailable  in  their 
clinical practice. 

To ensure that reporting obligations focus on the devices with the greatest potential impact on public 
health, EMA and the Executive Steering Group on Shortages of Medical Devices (MDSSG) would 
draw  up  and  publish  an  EU  list  of  these  critical  devices  or  device  categories.  These  proposed 
measures  aim  to  streamline  reporting  of  potential  or  actual  supply  disruptions  into  a  single  EU 
mechanism, reducing  duplication for manufacturers and improving coordination and transparency 
across the Union. It also provides hospitals and users of devices prior information of shortages or 
possible  disruptions  that  could  result  in  shortages,  supporting  continuity  of  care  and  ensuring 
continued availability of devices to patients and healthcare systems. The system enables coordinated 
mitigation  when  shortages  have  cross-border  consequences  and  therefore  strengthens  crisis 

40 

 
 
 
 
 
preparedness.  In  conclusion,  the  proposed  amendment  aims  at  a  more  coherent  Union-wide 
monitoring framework that enhances patient safety, legal certainty, and crisis preparedness,  while 
easing administrative burden on both authorities and manufacturers.  

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.10.2. Simplified process for measures in emergency situations  

The  proposed  revision  strengthens  the  Commission’s  capacity  to  act  in  emergency  situations, 
allowing for temporary Union-wide derogations where urgent measures are necessary to ensure the 
availability  of  critical  medical  devices  or  to  safeguard  public  health.  This  empowerment  reflects 
lessons  learned  from  the  COVID-19  pandemic,  as  reflected  also  in  the  targeted  evaluation  of  the 
MDR  and  IVDR,  when  fragmented  national  derogations  led  to  inconsistent  application,  parallel 
administrative procedures, and delayed access to essential devices.  

The proposed empowerment enables a faster and more harmonised Union response in emergency 
situations.  By  allowing  the  Commission  to  adopt  temporary  and  coordinated  derogations  or 
regulatory action, the proliferation of parallel or diverging national derogations is avoided and the 
availability of critical devices during crises can be facilitated. This is further supported by improved 
coordination among Member States, contributing to more harmonised approaches across the Union. 
At the same time, the introduction of clear rules for emergency decisions enhances legal certainty for 
manufacturers  and  competent  authorities,  reducing  administrative  complexity  and  ensuring 
predictable implementation. The proposal for revision also promotes more efficient use of resources, 
as streamlined Union coordination would prevent duplication of assessments and support coherent 
crisis management efforts. 

Overall, this measure strengthens the EU’s preparedness and resilience in responding to future health 
emergencies.  It  provides  a  consistent  and  transparent  framework  for  action,  improving  both  the 
responsiveness and legal clarity of the regulatory system while safeguarding the continuity of supply 
for essential medical technologies. This measure is expected to facilitate faster access to the market 
for  manufacturers  producing  critical  medical  devices  during  an  emergency,  support  national 
competent authorities in taking coordinated decisions, and most importantly provide for continued 
availability of critical medical devices to healthcare systems and patients in a time of emergency.  

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability.  

3.10.3. Digital labels   

The proposal for revision introduces the possibility for digital labelling of medical devices and IVDs, 
to be established through a future Commission implementing act, following the model of the existing 
electronic Instructions for Use (eIFU) Regulation (EU) 2021/2226. This measure would allow certain 
information currently printed on physical labels to be provided in electronic form, while maintaining 
essential safety information on the device or its immediate packaging. 

A pragmatic, risk-based approach would guide implementation: information critical for safe use and 
identification  would  remain  physically  displayed,  whereas  other  elements,  may  transition  to 
electronic access. 

41 

 
This measure would be expected to come with  several benefits for both  manufacturers and users: 
reduced  printing,  packaging  and  distribution  costs,  faster  updates  and  reduced  risk  of  errors,  and 
potential  for  improved  accessibility  for  readers  such  as  bigger  symbols.  Overall,  digital  labelling 
supports a more efficient, flexible, and sustainable regulatory framework while improving access to 
accurate information for patients and healthcare professionals. 

Note:  While  this  measure  is  expected  to  generate  efficiencies  and  cost  savings,  these  cannot  be 
reliably quantified due to factors such as case by case variation, fluctuations over time or frequency 
of cases or data complexity and/or availability. 

4.  CONCLUSIONS 

The  targeted  revision  of  the  MDR  and  IVDR  aims  to  address  the  structural  challenges  observed 
during implementation, while fully preserving the Regulations’ objectives of “a robust, transparent, 
predictable and sustainable regulatory framework for medical devices which ensures a high level of 
safety and health whilst supporting innovation”. Building on the framework’s decentralised approach 
and harmonising the practices of notified bodies and of Member States, the initiative aims for a leaner, 
more cost-effective, and more predictable system. This would not only lower compliance costs for 
stakeholders  across  sectors  but  would  also  provide  greater  certainty,  enabling  more  confident 
planning of research and development activities. All in all, the measures put forward by the proposal 
aim to shift from fixed-frequency to risk-based processes, improve proportionality by differentiating 
more  appropriately  between  lower  and  high-risk  devices,  reduce  administrative  burden  and 
redundances in processes and provide more legal certainty and predictability. Ultimately the proposal 
aims to ensure continued availability of safe and performant devices for patients. 

This analysis provides an overview of cost savings of some of the major measures put forward by the 
proposal and places particular emphasis on manufacturers, the stakeholder group with the biggest 
cost saving. In this context, the quantified cost-saving estimates focus on manufacturers and include 
a breakdown, where possible of savings across micro, small, medium and large enterprises, reflecting 
the  differentiated  impact  by  company  size.  The  available  data  did  not  consistently  allow  for  a 
meaningful assessment of cost reductions expected to also benefit other stakeholder groups, including 
notified bodies, competent authorities, healthcare institutions or other actors. It should also be noted 
that certain broader public health benefits—such as faster patient access to innovative technologies, 
efficiencies resulting from clearer classification rules, and overall system-level improvements—are 
inherently difficult to quantify. Nonetheless, these impacts are expected to generate meaningful value 
for patients and healthcare systems and are qualitatively described under each measure, as they cannot 
be expressed through numerical estimates. 

As for the methodology employed for the quantified measures, publicly available data, information 
provided  by  manufacturers,  notified  bodies,  national  authorities,  healthcare  institutions  and  other 
relevant stakeholders was utilised (see bibliography). As in several cases the data was not always 
consistent,  or  available  only  from  a  limited  number  of  sources,  the  results  are  likely  to  be  an 
underestimate and should be interpreted with the abovementioned limitations in mind. 

Proposed measures aimed at facilitating the generation of clinical or non-clinical evidence include 
expanding the conditions under which equivalence, based on publicly available information, may be 
used, and recognises different types of literature, real-world evidence and validated non-clinical or 
in silico methods as acceptable sources of data, among others. In addition, certain simplifications of 
processes  related  to  performance  studies  and  clinical  investigations,  as  well  as  administrative 
simplification related to the summary of safety and (clinical) performance are expected to provide an 
administrative and financial relief to the sector. Based on stakeholder input, the estimated savings 

42 

 
arising from the measures related to generation of evidence could amount to around €311 million per 
year.  

A significant part of the cost burden under the current framework stems from cyclical activities as 
part  of  conformity  assessment,  such  as  change  management  activities,  annual  activities  related  to 
sampling of technical documentation and recertification. The introduction of predetermined change 
control plans (PCCPs) enables predictable and more efficient handling of foreseeable modifications 
and  associated  administrative  cost  reductions.  The  most  substantial  savings  arise  from  replacing 
systematic sampling of technical  documentation  with  reviews that are carried out when there is  a 
clear  reason  or  risk  signal.  The  precise  cost  saving  calculation  is  subject  to  some  uncertainties, 
including  variation  in  manufacturers’  portfolio  size  and  composition,  sampling  intensity  and  fee 
variation  between  notified  bodies,  and  the  proportion  of  reviews  that  would  still  be  triggered  by 
specific concerns. Nevertheless, the significant reduction in workload associated with this measure 
is expected to generate savings of a significant order of magnitude. Moreover, the proposal to replace 
recertification every five years with a lighter periodic review focused on ongoing compliance and 
post-market performance is expected to provide further relief. The measures also include reduction 
in  frequency of fixed  audits,  administrative simplification of periodic safety  update reporting and 
reduction  in  duplication  of  assessment  of  serious  incidents.  Overall,  the  general  conformity 
assessment measures are estimated to provide around €2.1 billion in savings per year.  

In  addition  to  the  above,  there  are  several  measures  specific  to  particular  types  of  devices.  This 
includes putting in place accelerated conformity assessment pathways for orphan and breakthrough 
devices. Devices falling under the breakthrough category are estimated to benefit from opportunity-
cost savings from faster access to market, estimated at around €570 million per year (figure estimated 
relying on assumptions about the number of devices that would qualify and the value attributed to 
earlier market access). Simplification from removal of notified-body involvement for class I reusable 
surgical instruments (when harmonised standards or common specifications are applied) and class A 
sterile  IVDs,  removal  of  individual  technical  documentation  assessment  for  near-patient  tests, 
simplified treatment of companion diagnostics covering multiple medicinal products and mandatory 
fee reductions for micro and small  enterprises—50% and 25%  respectively—provide further  cost 
combined cost savings of around €122 million per year. Further measures such as grandfathering for 
certain orphan devices and simplification for devices manufactured and used in a health institution 
are based on qualitative or semi-quantitative data and are expected to result in further savings.  

Furthermore,  several  cross-cutting  measures  are  expected  to  enhance  predictability  and  improve 
coherence across the internal market. Early advice and structured dialogue mechanisms are expected 
to provide support to manufacturers at early stages of conformity assessment, reducing the likelihood 
of  divergent  interpretations  or  iterative  assessments  and  providing  an  estimated  €146  million  in 
annual savings (figure calculated using assumptions about frequency of their use, individual saving 
rates and associated fees). Reliance on MDSAP, where appropriate, avoids duplicative administrative 
processes for manufacturers placing devices on the market in several jurisdictions and could result in 
around €92 million in annual saving, although this depends on current and future uptake rates. The 
establishment of a Union-level system for monitoring supply disruptions provides qualitative benefits 
by  reducing  fragmented  reporting.  Several  measures  also  aim  to  streamline  interaction  among 
authorities and between various actors in the conformity assessment framework, such as improved 
mechanisms for notified body designation and monitoring, resolving qualification and classification 
issues, disputes in conformity assessment, and regulatory sandboxes. They represent simplifications 
that are expected to result in increased efficiency of the regulatory framework and savings for many 
actors in the system.  

43 

 
In  conclusion,  the  targeted  revision  of  the  MDR/IVDR  represents  a  strategic  initiative  aimed  at 
supporting  EU  competitiveness  and  innovation,  notably  providing  relief  to  SMEs,  through 
streamlined  conformity  assessment  and  overall  functioning  of  the  regulatory  system,  bringing 
substantial  annual  savings.  The  measures  remain  fully  aligned  with  the  Regulations’  objective  of 
ensuring a high level of safety and health, as they simplify requirements in areas where this does not 
compromise  safety  or  performance.  Moreover,  competitiveness  and  innovation  are  integral  to 
safeguarding high-quality patient care, since patient safety also depends on the timely availability of 
effective  medical  devices.  By  supporting  a  more  efficient  and  innovation-friendly  system,  the 
measures  ultimately  help  ensure  that  patients  continue  to  have  access  to  the  devices  they  need. 
Overall, the combined quantifiable impact of the simplification measures described in this document, 
taking into account the limitations and assumptions outlined throughout, is estimated to reach around 
€3.3 billion per year, including estimated €0.9 billion in adjustment costs savings and €2.4 billion in 
administrative  cost  savings.  Alongside  financial  relief,  the  measures  aim  to  put  in  place  a 
proportionate,  efficient  and  flexible  framework,  increase  legal  certainty,  support  more  coherent 
implementation across the Union and sustain the high level of health protection set out in the MDR 
and IVDR. 

44 

 
 
 
5.  BIBLIOGRAPHY 

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final, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0047. 

Belgian FAMHP register for devices, 
https://www.vas.ehealth.fgov.be/registers/sadm/web/search/public. 

BVMed,  MedicalMountains,  SPECTARIS  and  VDGH  (2025),  Impact  of  EU  Regulations  MDR 
(2017/745) and IVDR (2017/746) on innovation, competitiveness and security of supply in the EU – 
Results  of  an  industry  survey  2025,  https://www.bvmed.de/download/mdr-ivdr-survey-results-
2025.pdf. 

Choose Europe for life science: A strategy to position the EU as the world’s most attractive place for 
life 
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content/EN/TXT/?uri=CELEX%3A52025DC0525. 

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turnover, 
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turnover/.  

than  5%  of  annual 

Confindustria  Dispositivi  Medici,  Il  settore  in  numeri  2024,  https://www.confindustriadm.it/il-
settore-in-numeri-2024/. 

DIHK,  MedicalMountains  and  SPECTARIS  (2023),  Current  assessment  of  the  German  medical 
device manufacturers on the effects  of the EU  Medical  Device Regulation  (MDR) 2023,  Current 
assessment of the German medical device manufacturers on the effects of the EU Medical Device 
Regulation 
(MDR), 
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S_MDR_Survey_2023.pdf. 

(2024),  Much  More  Than  A  Market  –  Speed,  Security,  Solidarity, 

Enrico  Letta 
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letta.pdf. 

European Commission, Eudamed, https://ec.europa.eu/tools/eudamed/. 

European Commission, Published fees on notified body websites, Published fees on notified bodies 
websites 
services, 
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fcf3da4acd15_en?filename=md_nbs_fees_en.pdf. 

for  MDR 

related 

(Table 

(Table 

IVDR 

and 

1.) 

2.) 

European Commission (2023), Communication from the Commission to the European Parliament, 
the Council, the European Economic and Social Committee and the Committee of the Regions, SME 
Relief  Package,  https://single-market-economy.ec.europa.eu/document/download/8b64cc33-b9d9-
4a73-b470-8fae8a59dba5_en?filename=COM_2023_535_1_EN_ACT_part1_v12.pdf. 

45 

 
European  Commission 
https://commission.europa.eu/topics/competitiveness/draghi-report_en. 

The  Draghi 

(2024), 

report 

on 

EU 

competitiveness, 

European  Commission  (2025),  Call  for  Evidence  on  the  targeted  revision  EU  rules  for  medical 
devices and in vitro diagnostics, Medical devices and in vitro diagnostics – targeted revision of EU 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-
rules, 
devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en. 

European  Commission  (2025),  Public  consultation  –  EU  rules  on  medical  devise  and  in  vitro 
targeted  evaluation,  https://ec.europa.eu/info/law/better-regulation/have-your-
diagnostics  – 
say/initiatives/14155-EU-rules-on-medical-devices-and-in-vitro-diagnostics-targeted-
evaluation/public-consultation_en. 

European  Council  (2024),  Employment,  Social  Policy,  Health  and  Consumer  Affairs  Council 
(Health), 3 December 2024, https://www.consilium.europa.eu/en/meetings/epsco/2024/12/03/. 

European Parliament (2024), European Parliament resolution of 23 October 2024 on the urgent need 
to revise the Medical Devices Regulation, https://www.europarl.europa.eu/doceo/document/TA-10-
2024-0028_EN.html. 

Expert input from AKRA Team GmbH. 

GÖG et al. (2022–2025) Study supporting the monitoring of availability of medical devices on the 
EU  market.  Data  extracted  from  February  2025,  https://health.ec.europa.eu/study-supporting-
monitoring-availability-medical-devices-eu-market_en. 

GÖG  et  al.  (2025)  Study  supporting  the  monitoring  of  availability  of  medical  devices  on  the  EU 
market,  17th  Notified  Body  survey,  https://health.ec.europa.eu/study-supporting-monitoring-
availability-medical-devices-eu-market_en. 

Global Unique Device Identification Database (GUDID), https://accessgudid.nlm.nih.gov/. 

de 
I.P., 
INFARMED 
https://extranet.infarmed.pt/SIDM-fo/. 

Sistema 

Informação 

para  Dispositivos  Médicos 

(SIDM), 

Italian  National  Database,  Elenco  dei  dispositivi  medici,  accessed  November  2025, 
https://www.salute.gov.it/interrogazioneDispositivi/. 

Medical Device Single Audit Program (MDSAP), https://www.mdsap.global/. 

MedTech Europe (2021), Results: Market composition of in vitro diagnostic medical devices (IVDs), 
https://www.medtecheurope.org/wp-content/uploads/2021/09/medtech-europe-survey-report-
detailed-results.pdf. 

(IVDs) 

MedTech Europe (2021),  Survey Report analysing the availability of  In vitro Diagnostic Medical 
Devices 
applies, 
https://www.medtecheurope.org/wp-content/uploads/2021/09/medtech-europe-survey-report-
analysing-the-availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-
eu-ivd-regulation-applies-8-september-2021.pdf. 

IVD  Regulation 

2022  when 

new  EU 

in  May 

the 

MedTech  Europe 
content/uploads/2024/07/medtech-europes-facts-figures-2024.pdf. 

(2024),  Facts  &  Figures  2024,  https://www.medtecheurope.org/wp-

46 

 
MedTech Europe (2024), IVDR & MDR Survey Results 2024. https://www.medtecheurope.org/wp-
content/uploads/2025/01/mte_report_ivdr_mdr_2024-v7.pdf. 

MedTech  Europe 
content/uploads/2025/09/medtech-europe-facts-and-figures-2025-digital-1.pdf. 

(2025),  Facts  and  Figures  2025,  https://www.medtecheurope.org/wp-

MedTech  Europe 
content/uploads/2025/07/250730_ivd-sampling-reflection-paper_final_pub.pdf. 

(2025),  Sampling  under 

IVDR,  https://www.medtecheurope.org/wp-

Regulation (EU) 2022/112, OJ L 19, 28.1.2022, pp. 3–6, ELI: 
http://data.europa.eu/eli/reg/2022/112/oj. 

Regulation (EU) 2023/607, OJ L 80, 20.3.2023, pp. 24–29, ELI: 
http://data.europa.eu/eli/reg/2023/607/oj. 

Regulation (EU) 2024/1860, OJ L, 2024/1860, 9.7.2024, ELI: 
http://data.europa.eu/eli/reg/2024/1860/oj. 

Regulation (EU) 2024/568, OJ L, 2024/568, 14.2.2024, ELI: 
http://data.europa.eu/eli/reg/2024/568/oj. 

Targeted  surveys  and/or  workshops  with  national  competent  authorities,  large  and  medium 
manufacturers, micro and small manufacturers, notified bodies, health institutions. 

Team-NB  (2024),  Medical  Device  Survey  2024,  Medical  Device  Survey  2024  Data  from  all  41 
designated members, https://www.team-nb.org/wp-content/uploads/2025/06/Survey-2024.pdf. 

Team-NB (2025), Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 
2017/746,  https://www.team-nb.org/wp-content/uploads/2025/06/Code-of-Conduct-Team-NB-V5-
1-20250625.pdf. 

Team-NB  (2025),  Position  Paper  on  Changes  to  companion  diagnostic  devices  under  the  IVDR, 
Annex  IX,  section  5.2  that  require  prior  approval  by  a  notified  body,  Team-NB  Position  Paper, 
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changes-V2.pdf. 

Ursula  von  der  Leyen  (2024),  Europe’s  choice,  Political  guidelines  for  the  next  European 
Commission  2024−2029,  https://commission.europa.eu/document/download/e6cd4328-673c-4e7a-
8683-f63ffb2cf648_en?filename=Political%20Guidelines%202024-2029_EN.pdf. 

US  FDA,  Breakthrough  devices  program,  https://www.fda.gov/medical-devices/how-study-and-
market-your-device/breakthrough-devices-program. 

US  FDA,  Companion  diagnostics,  https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-
cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. 

Vermeersch P, Van Aelst T, Dequeker EMC. 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 
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2020 Jul 21;59(1):101-106. doi: 10.1515/cclm-2020-0804. PMID: 32692695. 

47 

 
 
 
ANNEX I:   SYNOPSIS OF STAKEHOLDER CONSULTATION 

1.  Consultation approach 

The  Commission  conducted  a  targeted  and  proportionate  stakeholder  consultation  to  inform  the 
revision of the Regulations, in particular in the refinement of the proposed measures and to collect 
specific evidence on their expected costs savings or potential additional costs incurred.  

First, the targeted revision of the Regulations results from the findings of the targeted evaluation33 
that  has  been  launched  in  2024.  The  targeted  evaluation  was  informed  by  extensive  consultation 
activities, including a Call for Evidence and a Public Consultation (12 December 2024 to 21 March 
2025)34, which were complemented by targeted consultation activities. 

Second, to inform the preparation of the simplification proposal a specific Call for Evidence was 
open for feedback from 8 September to 6 October 202535. A total of 427 individual feedback36 and 
166  attachments37  were  considered  valid.  The  final  analysis  is  based  on  these  427  feedback 
contributions  and  165  attachments38.  Position  papers  sent  by  stakeholders  to  the  European 
Commission were also taken into consideration. 

Third, targeted consultation activities  have been conducted.  This  encompassed targeted surveys 
and/or  workshops  for  the  following  groups:  national  competent  authorities,  large  and  medium 
manufacturers, micro and small manufacturers, notified bodies, health institutions. 

2.  Overview of respondents to the Call for evidence  

In  terms  of  stakeholder  groups,  companies  and  businesses  were  the  largest  contributors  (199 
contributions, 46.6%) followed by business associations (61 contributions, 14.29%). Notified bodies 
were identified separately (5 contributions, 1.17%). The other represented groups were NGOs (36 
contributions, 8.43%), academic / research institutions (31 contributions, 7.26%), public authorities 
(13  contributions,  3.04%),  trade  unions  (6  contributions,  1.41%)  and  consumer  organisations  (1 
contribution) as well as from stakeholders that selected ‘Others’ (30 contributions, 7.03%). A large 
number of feedback came from citizens, including 37 feedback from EU citizens (8.67%) and 8 from 
non-EU citizens (1.87%). 

As part of the participating public authorities, the scope varies, with 8 national authorities, 4 regional 
authorities and one local authority. However, feedback from this group should be interpreted with 
care as some feedback were submitted by stakeholders representing health providers,  

A  large  majority  of  contributing  companies/businesses  represented  SMEs  (129  feedback,  64.8%) 
with 34 medium-, 54 small-, 41 micro- sized companies.  

In terms of geographical scope, the respondents to the Call for Evidence were mostly from Germany 
(100 feedback, 23.42%), Belgium (48 feedback, 11.24%) and France (39 feedback, 9.13%). Other 

33 [Placeholder for SWD Targeted Evaluation, SWD(2025)1051] 
34 European Commission website, EU rules on medical devices and in vitro diagnostics – targeted evaluation. 
35 European Commission website, Medical devices and in vitro diagnostics – targeted revision of EU rules. 
36 This included 1 contribution discarded as not respecting the feedback rules, 5 contributions from 4 contributors were removed as 
considered duplicates, and 14 contributions were merged into 6 contributions as considered complementary feedback. 
37 As part of the 171 attachments received in the CFE, 5 were not taken into account in the analysis (1 attachment from the discarded 
feedback,  2  attachments  were  part  of  the  above  duplicates,  and  one  document  was  sent  3  times  by  one  contributor  (merged 
contributions)).  
38 The one attachment sent 3 times by one contributor was considered off-topic. 

48 

 
 
participants  were  from  Sweden  (33  feedback,  7.73%)  and  the  Netherlands  (31  feedback,  7.26%) 
followed by respondents from the United Kingdom (22 feedback, 5.15%) and the United States (20 
feedback, 4.68%). 

3.  Stakeholder views: 

3.1.General views on the targeted revision 

Feedback  to  the  call  for  evidence  indicated  that  respondents  agreed  with  the  identified  hurdles 
stemming from the Regulations. They referred to their disproportionate costs, high administrative 
burden  and  overall  regulatory  complexity,  also  echoing  the  findings  of  the  targeted  evaluation. 
Stakeholders  showed  overall  broad  support  for  measures  aiming  at  simplifying  and  making  the 
regulatory framework more proportionate and efficient, reducing administrative burden, and allowing 
for more flexibility to support innovative devices to reach the market.  

Respondents across all stakeholder groups overall recognized the objectives of the Regulations and 
stressed that maintaining safety standards and a high level of public health, including by ensuring 
the availability of devices or by supporting innovation for small population groups, should remain at 
the centre of the revision.  

Overall, stakeholders underlined the need for a risk-based approach to requirements, supported 
greater digitalisation and a more efficient governance. Feedback included proposed changes related 
to  several  areas,  including  clinical  and  post-market  data  requirements,  simplification  and  greater 
predictability of the conformity assessment process, as well as changes related to audits and post-
market surveillance 

Feedback  also  particularly  emphasized  the  implications  of  the  Regulations  for  SMEs  as  costs  to 
comply  with  the  requirements  are  viewed  as  particularly  disproportionate  for  SMEs;  many 
stakeholders are asking for SMEs’ needs to be taken into account. 

3.2. Detailed analysis 

The detailed analysis is based on feedback received through the Call for Evidence and other channels. 

3.2.1.  Legal clarity 

Stakeholders stressed the need to clarify some definitions and terms in the Regulations to improve 
the  legal  clarity  of  the  framework.  Examples  of  terms  mentioned  in  feedback  received  included 
intended use and intended purposes, as well as substantial changes, custom-made, patient-matched 
or mass-produced devices. 

Concepts that stakeholders believe should be considered as part of the regulatory framework include 
well-established technologies, orphan devices and breakthrough devices.  

Some stakeholders are also seeing the definition of health institutions unclear and too narrow, asking 
for  a  revised  definition  notably  as  regards  organisations  that  use  devices  in  clinical  trials,  and 
improved coherence with the Clinical Trials Regulation. 

3.2.2.  Clinical evidence, clinical investigations and performance studies 

The  need  to  allow  for  more  flexibility  in  the  requirements  for  clinical  evidence  was  underlined. 
Feedback concerned the evidence required as part of clinical investigation and performance studies 

49 

 
but also greater use of evidence generated in the post-market phase (e.g. during post-market clinical 
follow-up (PMCF). 

First, there was feedback calling for a broader recognition of clinical data from equivalent devices, 
which as a result would allow for more flexibility in the requirements for clinical evidence. 

Second, stakeholders across various groups supported broader definition of clinical data and greater 
guidance  and  use  of  non-clinical  evidence.  Feedback  varied  in  the  examples  cited,  which  mainly 
covered the use of real-world evidence, data from registries, literature data, post-market data, or in-
silico methods. 

Thirdly  some  stakeholders  argued  that  the  requirements  for  clinical  investigations  and  for 
performance studies should be more risk-proportionate 

3.2.3.  Classification 

Stakeholders  expressed  concerns  on  the  rules  related  to  the  classification  of  devices  under  the 
Regulations.  Stakeholders  are  calling  for  more  predictability  in  the  classification  of  devices  – 
including for instance through clearer guidance on certain devices - but also for revised classification 
rules  that  are  more  risk-proportionate.  Many  contributions  underlined  challenges  in  software 
classification. 

3.2.4.  Conformity assessments and re-certification 

With regards to conformity assessments, contributions across many stakeholder groups underlined 
the  high  costs  and  lengthy  conformity  assessment  procedures;  representatives  of  companies, 
including  SMEs,  indicated experiencing  a lack of predictability and diverse interpretations across 
notified  bodies  and  competent  authorities.  Stakeholders  are  calling  for  simplification  of  the 
conformity assessment procedures and in particular of re-certification of devices. 

As part of the proposed measures, some stakeholders advocated for the setting of maximum timelines 
for conformity assessment.  

Some stakeholders also support greater harmonisation of documentation. One example suggested 
further harmonization in the templates and technical documentation required by notified bodies for 
conformity assessment under the IVDR. 

To  improve  the  transparency  and  predictability  of  the  system,  stakeholders  also  ask  for  the 
publication  of  transparent  information  from  notified  bodies  such  as  on  their  fees  structure, 
timelines, performance. Other proposed changes were the definition of maximum prices, the set-up 
of fee systems with premium charges for accelerated procedures, or reduced fees for SMEs.  

Furthermore, many stakeholders advocate for adapted conformity assessment pathways for special 
types of devices. Stakeholders indicated different categories of devices to which these specific rules 
could apply, such as innovative products, especially breakthrough, devices for patients with specific 
needs (e.g. orphan devices, paediatric devices, niche products), as well as low risk devices. 

As part of the suggested changes to streamline the conformity assessment procedures, stakeholders 
proposed to simplify the re-certification requirements for both MDs and IVDs. Various proposals 
were  made  in  this  context,  including  defining  more  proportionate  requirements  for  notified  body 
activities during re-certification. Suggestions also included the extension of the certificate duration, 
permanent validity of certificates or limiting recertification to certain cases subject to criteria. Instead 

50 

 
of  regular  re-certification  cycles,  stakeholders  proposed  to  rely  on  continued  post-market 
surveillance. 

3.2.5.  Views on specific devices 

•  In-house devices 

Stakeholders  also  underlined  the  need  for  measures  to  simplify  the  regulatory  framework  for  in-
house devices manufactured and used by health institutions.  

Due  to  the  administrative  burdens  and  costs  associated  with  current  framework,  stakeholders 
indicated risks related to reduced development  and use of in-house devices by health institutions, 
leading  to  reduced  access  of  patients  to  such  devices  (e.g.  to  novel  diagnostics  for  rare  diseases, 
prenatal samples, expansion of personalized medicines), impact on innovation (as some laboratories 
may discontinue or choose not to develop new devices, etc) or the challenges of rapidly evolving 
areas and preparedness for crises (e.g. infectious disease diagnostics).  

The  suggested  regulatory  changes  mainly  focused  on  ensuring  proportionate  requirements  for  in-
house devices (e.g. Article 5.5, for instance on requirements related to equivalence, on allowing to 
share devices between laboratories, etc.) and the possibility to rely on international standards (e.g. 
ISO 15189 for IVDs) instead of the requirements set out in Annex 1 of the Regulation. 

•  Software 

The main request (from stakeholders across various groups) in relation to software is a revision of 
the current classification rules (as per MDR, Rule 11) to  allow for their classification as low-risk 
devices in order to reflect the use of the device and the associated risks. Stakeholders view the current 
classification system as stringent and disproportionate, with most software being classified Class IIa 
devices,  thus  applying  the  related  regulatory  requirements  to  this  class  of  devices.  Different 
classification would lead to proportionate evidence requirements. 

Other suggestions covered the development of more expertise on software e.g. for notified bodies. 

•  Well-established technologies and grandfathering. 

Stakeholders across various stakeholder groups, mainly the industry, NGOs, notified bodies and some 
citizens, are calling for more recognition of well-established technology devices (WET) in order to 
make the regulatory system more proportionate for them. 

In this context, some feedback underlined the need to clarify the definition of WET including to 
replace the current list of WET, or to define common specifications.  

Furthermore, simplified clinical evaluation requirements and adjusted conformity assessment 
procedures were proposed for well-established technologies with low risks or long history of safety. 

Stakeholders  mainly  representing the industry favoured  grandfathering  provisions for both  MDs 
and  IVDs,  asking  to  carry  over  the  validity  of  certificates  granted  under  the  Directives  to  the 
Regulations,  with  devices  with  long  safety  history,  especially  low-risk  devices,  often  cited  as 
examples. 

3.2.6.  Reporting obligations 

51 

 
Several  stakeholders  are  calling  for  streamlining  of  reporting  requirements.  Some  feedback 
stressed the perceived high costs associated with meeting these requirements.  

Some  industry  respondents  stress  the  overlap  between  the  summary  of  safety  and  (clinical) 
performance with other documents and called for reduction of unnecessary validation and translation 
of these summaries. 

Significant feedback was received regarding overlapping requirements in the context of the post-
market  surveillance  and  vigilance.  Respondents  called  for  reduction  in  overlap  between  different 
post-market surveillance documents such as the Post Market Surveillance plan, Post Market Clinical 
Follow-Up plan, Post-Market Surveillance Report, the Post-Market Clinical Follow-up Report and 
the Periodic Safety Update Report, as well as reduced frequency of reporting for lower-risk devices. 
Notified  bodies  acknowledged  duplication  in  assessment  of  serious  incidents  between  competent 
authorities and notified bodies. 

Finally,  a  few  contributions  also  covered  concerns  on  high  frequency  of  audits,  including 
unannounced audits. 

3.2.7.  Sampling of technical documentation 

Both notified bodies and industry referred to unclear expectations as regards sampling of technical 
documentation, the high costs of this process, especially for SMEs, and its resource-intensive nature 
for both manufacturers and notified bodies. Respondents called for minimised mandatory sampling, 
and  greater  focus  on  post-market  surveillance  and  changes.  Notified  bodies  also  pointed  out 
contradictions between sampling rules and requirements for validation of the summary of safety and 
(clinical) performance. 

3.2.8.  Views on support mechanisms 

•  Early dialogue 

When it comes to early dialogues, stakeholders, including both large companies and SMEs indicated 
the need for dialogues with notified bodies (or expert panels on clinical evidence generation prior to 
submissions, especially for innovative devices. Feedback from notified bodies echoes the possibility 
to have early dialogues with the industry, indicating that this would enhance the predictability and 
efficiency  of  the  conformity  assessments  without  lowering  the  requirements.  Some  feedback  also 
proposed dialogues with national authorities or the EMA. 

•  Regulatory sandboxes 

Stakeholders advocated in general for measures supporting innovation to reach the market. A few of 
them specifically proposed the introduction of regulatory sandboxes in the regulatory framework. 

3.2.9.  Digitalisation  

Stakeholders from various groups (trade unions, public authorities, business associations) are calling 
for accelerated and secured deployment and use of EUDAMED.  

Some stakeholders’ feedback also favoured greater use of digital tools, proposing the digitalisation 
of  procedures  such  as  digital  technical  documentations,  and  audits.  Other  mentioned  the  broader 
availability of electronic instructions for use or digital label. 

52 

 
Stakeholders across various groups stressed some challenges related to the requirements of unique 
device  identification  (UDI)  and  highlighted  areas  for  improvement.  Company  and  business 
association  feedback  focused  on  the  need  for  clear  guidance  on  UDI  management  (including  for 
software changes), overall code formatting and clarifications on UDI direct marking requirements in 
some  cases.  Distributors,  including  pharmacies  underscored  logistical  challenges  with  UDI 
requirements  sampling  obligations,  and  repackaging  rules  and  related  costs.  Stakeholders  who 
identified themselves as ‘Other’ highlighted challenges in fulfilling healthcare institution obligations 
to store UDI of high-risk implantable devices, including variation in UDI codes and lack of electronic 
systems  leading  to  difficulties  in  identifying  devices.  They  also  underlined  the  overall  need  for 
improved incident reporting systems. 

3.2.10. Governance  

Stakeholders also call for an enhanced governance system, to help ensure harmonised interpretation 
of the requirements, predictability, oversight of notified bodies and efficient resolution of disputes.   
In  this  perspective,  recommendations  included  improved  coordination  among  governance  actors, 
clearer roles and enhanced accountability.  

Some stakeholders specifically referred to a centralised governance system, mentioning expected 
benefits in building expertise and increased confidence in the system. Finally, the involvement of 
patients in the governance was mentioned in the feedback. 

3.2.11. Coherence with other EU legislation 

Lastly,  stakeholders  advocated  for  measures  enhancing  the  coherence  with  other  EU  legislative 
frameworks, among others in the areas of clinical trials, artificial intelligence, access and use of data, 
and  the  general  data  protection  regulation  as  well  as  use  of  chemicals  and  environmental 
sustainability. 

In particular, many stakeholders identified the need to ensure greater harmonisation and alignment 
of rules governing medical devices and clinical trials, due to diverging timelines, inconsistencies in 
the requirements or duplications. 

53 

 
 
 
 
 
 
 
 
ANNEX II:   SUMMARY OF COST-SAVINGS 

54 

 
 
 
 
ANNEX III:   DISTRIBUTION OF DEVICES, CERTIFICATES, AND ENTERPRISES  

Table 1.1: Device distribution 

This table represents the distribution of the number of devices across various risk classes. The distribution of MDs across risk classes was derived from 
data extracted from the Italian National Database (Elenco39), which was used as a proxy for the Union market40. The distribution of IVDs across risk 
classes is taken from a survey performed by MedTech Europe41. This distribution was applied to the total number of IVDs extracted from Elenco42, with 
adjustment to the Union market. The Union market adjustment was calculated based on the above understanding that 80% of devices placed on the EU 
market were also placed on the Italian market. The proportion of class IIa and IIb implantable devices was estimated by selecting the relevant European 
Medical Device Nomenclature (EMDN) codes out of the total number of devices in the respective risk class. The distribution of devices requiring a QMS 
certificate was obtained by redistributing the relative proportions of each risk class after removing general class I devices and class A IVDs. 

39 Italian National Database, Elenco dei dispositivi medici. 
40 An assessment of possible nomenclatures for future use in the European Medical Device Database was conducted jointly by the Commission and an MDCG TF in 2018. This assessment also looked at the 
use of various nomenclatures, including the Classificazione Nazionale di dispositivi medici (CND).  Based on input received from industry at the time, it was estimated that 80% of devices placed on the EU 
market were also placed on the Italian market. 
41 MedTech Europe, Results: Market composition of in vitro diagnostic medical devices (IVDs), September 2021. 
42 Refer to footnote 38. 

55 

MD​Number of devices​% Implantable​% of the total number of devices needing QMS cert​IVD​Distribution​Number of devices​Class I​44%239,9760%-​Class A​21%25,200Class Is/m/r56%300,0240%5%Class A sterile​1%1,200Class IIa​620,00012.5%40%Class B​49%58,800Class IIb​620,00075%40%Class C​25%30,000Class III​220,000-15%Class D​4%4,800Total​2,000,000100%Total​100%120,000Distribution​31%31%11%100%27% 
 
 
 
 
 
Table 1.2: Certificate distribution 

These tables provide an overview of the estimated number of certificates distributed across device risk classes (tables on the left) and company size (tables 
on the right). As a starting point for the tables, the number of certificate applications were taken from GÖG et al. (2022–2025) dashboard43. 

-  For MDs (top left table): the numbers of applications were considered as representative of the “steady state”  number of  certificates when the 

transition to the MDR is fully completed (as the transition timelines are quite advanced). 

-  For IVDs (bottom left table): a factor was applied to account for future applications (as there are several years in the transition left). 

The estimates of the “steady state” QMS certificates were then further distributed according to device risk class as per table 1.1. 

43 GÖG et al. (2022–2025) 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. Data extracted from February 2025. 

56 

MDRisk class​Number in “steady state” after transition to Regulations completed (GOEG, applications 02/2025, assume all have applied already)​Breakdown of sampling vs individual technical documentation assessment ​% QMS certificates per risk class​Assumption that certificate distribution is same as device number distribution​Number of devices in the Union market (Elenco/0.8= 2M MDs)​Number of devices per certificate​Company sizeProportion of QMS certificates by company sizeNumber of QMS certificates by company sizeQMS per notified body clientQMS certificates for all Classes except IIb impl and III by company sizeQMS certificates for Class IIa by company sizeQMS certificates for Class IIb not impl by company sizeQMS certificates for Class IIb by company sizeQMS certificates for Class IIb non impl by company sizeI​0​0​0%0239,9760Micro15%2,8111.01,6941,1244241,124422Is/m/r​5%936300,000320Small26%4,8161.02,9031,9277261,927722IIa​40%7,489620,00083Medium27%5,0001.53,0142,0007532,000750IIb not impl​15%2,808155,00055Large29%5,4001.93,2552,1608142,160810IIb impl​25%4,681470,000100Supra large4%6945.0418278105278104III​15%2,808215,00077MD TD​7,438IVDRisk class​Number in “steady state” after transition to Regulations completed (GOEG, applications 02/2025, assume not all have applied yet)​Breakdown of sampling vs individual technical documentation assessment ​% QMS certificates per risk class​Assumption that certificate distribution is same as device number distribution​Number of devices in the Union market (Elenco/0.8= 120k IVDs)​Number of devices per certificate​Company sizeProportion of QMS certificates by company sizeNumber of QMS certificates by company sizeQMS per notified body clientQMS certificates for Class B by company sizeQMS certificates for Class C by company sizeA​000.0%025,2000Micro17%3041.018897As​1.3%241,20050Small28%5211.0323167B​62.0%1,13758,80052Medium26%4691.3290150C​32.0%58730,00051Large25%4651.6288149D​5.0%924,80052Supra large4%755.04724IVD TD​1,439IVD QMS​MD QMS​18,72211,2847,4381,833Cannot split by analogy to MDs as transition is not advanced enough​ 
 
 
 
-  For medical devices, the number of QMS certificates for class IIb implantable and class III devices was assumed to be the same as the number of 

product certificates for them. 

 The distribution of QMS certificates by company size in the tables on the right was obtained based on an assumption that the number of QMS certificates 
increases with company size (i.e., smaller manufacturers would have fewer manufacturing sites and thus fewer QMS certificates than larger manufacturers). 
This number was then further broken down by device risk class using the proportions from table 1.1. 

Note: The distribution of certificates across risk classes assumes that certificates cover devices of different classes separately. In reality, a certificate can 
cover devices falling under multiple risk classes (e.g. QMS certificate covering both IIa and IIb non-implantable devices). This assumption was necessary 
to be able to analyse certain device class specific measures.  

Table 1.3: Enterprise distribution 

This table represents the distribution of manufacturers placing devices on the Union market, distributed across manufacturer size. Left side represents the 
total number of manufacturers. Right side represents the number requiring notified body involvement. 

The  total  number  of  manufacturers  and  the  distribution  (90/10)  made  available  by  MedTech  Europe44  was  taken  into  consideration.  A  more  detailed 
breakdown by company size (micro, small, medium and large) was obtained taking into consideration the more detailed distributions collected by several 
national industry associations across Europe. The number of notified body clients was derived from GÖG et al. (2022–2025)45, while Team-NB data46 was 
used  to  establish  the  high-level  distribution  of  clients  across  manufacturer  groups  (79/21).  The  more  detailed  distribution  of  notified  body  clients  by 
company size was obtained using data from notified bodies. 

44 MedTech Europe, Facts and Figures 2025. 
45 Refer to footnote 42. 
46 Team NB, Medical Device Survey 2024 Data from all 41 designated members, 2024. 

57 

Total number of manufacturers (MTE)​High-level manufacturer distribution (MTE)​Distribution breakdown  (National associations)​Number of manufacturers per enterprise size​Number of notified body clients (GOEG)​High-level client distribution (Team-NB)​Distribution breakdown ​(GOEG backend)Number of clients per enterprise size​Number of notified body clients (GOEG)​High-level client distribution (Team-NB)​Distribution breakdown ​(GOEG backend)Number of clients per enterprise size​43%16,34020%2,81120,00020%30433%12,54035%4,81650,00035%52114%5,32024%3,33450,00024%3609%3,42020.0%2,77575,00020%3001%3801.0%139100,0001%1579%10%21%IVD manufacturers requiring notified body involvement​MD manufacturers requiring notified body involvement​Cost of auditTotal manufacturers (MD+IVD)​38,00090%13,8751,50079%21% 
 
 
 
ANNEX IV: DETAILED CALCULATIONS 

Generation of Evidence and Procedures for Performance Studies and Clinical Investigations 

Table 1: Use of equivalence, real-world evidence, in silico and other methodologies 

These tables estimate the cost saving from greater use of equivalence, real-world evidence and other methodologies for the generation of clinical evidence 
for medical devices and IVDs. The following parameters have been estimated with stakeholder and expert input: the number of clinical evidence packages 
per year, the costs per package, the relative proportions of packages generating evidence for new versus modified devices, and the expected saving from 
the use of these methodologies per package. The distribution of packages per class was based on the distribution of device classes (see table 1.1 in Annex 
III). Three scenarios of adoption rates were considered (conservative, moderate and high) with the understanding that modified devices would likely be 
able to benefit more from these methodologies than new devices. 

58 

Number of MD clinical evidence packages/year761,8755,000703,1251,465,000Cost of establishing clinical evidenceNumber of devicesProportion of devicesNumber of packagesCurrent costCost saving per packageAdoption rate of savingSavingAdoption rate of savingSavingAdoption rate of savingSavingNew class III and implantable€1,500,000114,2817.8%390585,057,594 €50%10%29,252,880 €20%58,505,759 €30%87,758,639 €New IIa and IIb non-impl€500,000105,4697.2%360179,980,802 €50%10%8,999,040 €20%17,998,080 €30%26,997,120 €Modif class III and implantable€250,000647,59444.2%2,210552,554,394 €50%30%82,883,159 €40%110,510,879 €50%138,138,599 €Modif class IIa and IIb non-impl€125,000597,65640.8%2,040254,972,803 €50%30%38,245,920 €40%50,994,561 €50%63,743,201 €Total1,465,000100.0%5,0001,572,565,593 €159,380,999 €238,009,279 €316,637,559 €Number of IVD clinical evidence packages/year300Cost of establishing clinical evidenceNumber of packagesCurrent costCost saving per packageAdoption rate of savingSavingAdoption rate of savingSavingAdoption rate of savingSavingNew IVDs€300,0004513,500,000 €30%10%405,000 €20%810,000 €30%1,215,000 €Modif IVDs€200,00025551,000,000 €30%30%4,590,000 €40%6,120,000 €50%7,650,000 €Total30064,500,000 €4,995,000 €6,930,000 €8,865,000 €ConservativeModerateHighTotal MD+IVD164,375,999 €244,939,279 €325,502,559 €HighConservativeModerateHighNumber devices: class III and Number devices: IIa and IIb non-TotalConservativeModerate 
 
 
 
Table 2: Removal of mandatory clinical investigations for class IIa implantable devices 

This table estimates the cost savings resulting from the removal of mandatory clinical investigation requirement for class IIa implantable devices.   

-  The total number of clinical investigations for all risk classes conducted across Europe47 in 2024 was used as a baseline, based on data collected 

from national competent authorities. 

-  Stakeholder and expert input supported the estimation of the share of these investigations attributed to class IIa implantable devices, with three 

estimates used (low, average and high). 

-  An average enrolment cost per patient was estimated. 
-  Three estimates were made for the number of patients typically enrolled in class IIa implantable clinical investigations. 

On the basis of these parameters, the total cost of such investigations was modelled across three scenarios, calculating the savings under conservative, 
moderate and high estimates. 

47 Data collected included responses from non-EU Member States such as countries in the European Economic Area (EEA). 

59 

ConservativeModerateHigh# of clinical investigations in 2024# of clinical investigations for Class IIa impl(lower)# of clinical investigations for Class IIa impl(average)# of clinical investigations for Class IIa impl(upper)Cost of a clinical investigation per patient enrolled# of patients enrolled in clinical investigations for Class IIa impl(lower)# of patients enrolled in clinical investigations for Class IIa impl(average)# of patients enrolled in clinical investigations for Class IIa impl(upper)Cost of a clinical investigation for Class IIa impl(lower)Cost of a clinical investigation for Class IIa impl(average)Cost of a clinical investigation for Class IIa impl(upper)Total cost saving(lower)Total cost saving(average)Total cost saving(upper)1032214162€10,000305070€300,000€500,000€700,000€6,192,000€20,640,000€43,344,000 
 
 
 
 
 
Table 3: Authorisation and notification of performance studies 

These tables estimate the cost savings linked to the simplification of authorisation and notification processes for certain performance studies. 

For routine blood draw performance studies, the average number of Member States involved per study was based on industry data. The number of such 
studies conducted annually across the EU was determined based on data both from national competent authorities and industry. Industry and expert input 
provided estimates of the administrative costs for sponsors per study (under three scenarios, lower, average and upper). Data from competent authorities 
was used to determine the average fee per Member State and the average cost of processing an application. Using these inputs, total cost savings for both 
industry and competent authorities were calculated under low, median, and upper scenarios. 

A similar approach was applied to companion diagnostic notifications, but the average number of Member States was not required due to the individual 
nature of notifications. 

60 

Industry saving:Number of studies (industry)Average number of Member States per study (industry)Internal admin costs of sponsor for study with average # of Member States (lower)Internal admin costs of sponsor for study with average # of Member States (average)Internal admin costs of sponsor for study with average # of Member States (upper)Number of applications per year (Member States)Number of studies (CAs)Average number of studies (both sources)Average fee per Member StateTotal fees for study with average number of Member StatesSaving industry(lower)Saving industry(average)Saving industry(upper)5.64.675€10,745.4316,118 €21,491 €429.07.32,336 €10,919 €157,976 €197,154 €236,331 €Competent authority resource saving:Number of performance studies (both sources)Average number of Member States per study (industry)Average cost of processing per Member StatesSaving national resources7.34.675€2,23976,335 €ConservativeModerateHighTotal (industry + national resources)409,786 €795,486 €946,876 €ConservativeModerateHighTotal (industry + national resources)234,311 €273,489 €312,667 €Industry saving:Number of notifications per year (CAs)Average sponsor internal cost per Member State (lower)Average sponsor internal cost per Member State (average)Average sponsor internal cost per Member State (upper)Average fee per Member StateSaving industry(lower)Saving industry(average)Saving industry(upper)276€813.131,220 €1,626 €267 €298,171 €410,383 €522,595 €Competent authority resource saving:Number of notifications per year (CAs)Average cost of processing per Member StateSaving national resources276404 €111,615 €ConservativeModerateHighTotal (industry + national resources)409,786 €521,998 €634,210 € 
 
 
 
 
Table 4: Coordinated assessment for clinical performance studies and clinical investigations that are also part of clinical trials 

This table estimates the cost savings arising from the coordinated assessment of clinical performance studies that are also part of a clinical trial. 

Data provided by competent authorities was used to determine the annual Union-wide number of authorisation requests, as well as the share of these 
requests linked to clinical trials. The average number of Member States involved per study, the range of the administrative costs for the sponsor and the 
average Member State fee were assumed to be the same as in the analysis of routine blood draw performance studies above. Industry consultations resulted 
in the selection of an estimated 30% reduction in costs when studies are conducted as a combined process rather than separate procedures. This reduction 
factor was applied to the costs, resulting in total savings across the conservative, moderate and high saving scenarios. 

61 

ConservativeModerateHighNumber of authorisation requests per yearOut of these, those linked to a clinical trial% requests linked to clinical trialAverage # of Member States per studyNumber of studies linked to a clinical trialSponsor internal admin cost for study with average # of Member States (lower)Sponsor internal admin cost for study with average # of Member States (average)Sponsor internal admin cost for study with average # of Member States (upper)Estimate of fees for study with average # of Member StatesEstimated cost saving from single process instead of separate processesSaving(lower) Saving(average) Saving(upper) 47737178%5.66610,74516,11821,4912,336 €30%260,126 €366,966 €473,806 € 
 
 
Table 5: Summary of safety and clinical performance (SSCP) and Summary of safety and performance (SSP) 

These  tables  estimate  the  cost  savings  associated  with  the  simplification  of  validation,  update/re-validation,  and  reduction  in  the  number  of  pages  of 
SS(C)Ps. More than one device can be covered under the same SS(C)P. The grouping of devices under SS(C)Ps was assumed to be the same as under 
PSURs in the table below. The scope of SS(C)Ps and PSURs differs in the coverage of class IIa devices. Taking this into account, the number of SS(C)Ps 
was derived based on the number of PSURs and the distribution of devices per risk class in Annex III. 

The top two tables focus on cost savings from removing the validation requirement. Based on data retrieved from notified bodies and industry, lower, 
median, and upper fee estimates for validation and update/re-validation were applied to determine the corresponding total cost savings. 

The bottom two tables focus on the cost savings due to the reduction in the number of pages of SS(C)Ps. The number of SS(C)Ps destined to healthcare 
professionals and patients, the estimated fraction of pages that would be removed, and the cost of drafting and translating SS(C)Ps were estimated based 
on industry and expert input. For IVDs, an additional cost saving was calculated based on the reduction of pages due to removal of duplication with the 
instruction for use. 

62 

# of Class IIa and IIb non impl PSURsPercentage that are Class IIa implantable# of SSCPs for Class Iia implantable# of SSCPs for IIb impl and IIITotal # of SSCPsValidation (Low fee)Validation (Median fee)Validation (High fee)Update/Re-validation (Low fee)Update/Re-validation (Median fee)Update/Re-validation (High fee)Total validation costs(Low fee)Total validation costs(Median fee)Total validation costs(High fee)Total update/re-validation costs(Low fee)Total update/re-validation costs(Median fee)Total update/re-validation costs(High fee)MD+IVDTotal saving validation (Low fee)Total saving validation (Median fee)Total saving validation (High fee)9,0797%6496,6037,252€2,076€2,745€4,068€1,697€2,407€3,624€13,775,143€18,214,243€26,992,911€11,260,317€15,971,469€24,046,782€15,484,203€20,742,413€31,358,929MD+IVDTotal saving update/re-validation(Low fee)Total saving update/re-validation(Median fee)Total saving update/re-validation(High fee)€14,525,558€19,932,018€29,368,238# of Class C and D PSURsN/A# of SSPs for Class C subject to sampling# of SSPs for Class D and Class C not samplingTotal # of SSPsValidation (Low fee)Validation (Median fee)Validation (High fee)Update/Re-validation (Low fee)Update/Re-validation (Median fee)Update/Re-validation (High fee)Total validation costs(Low fee)Total validation costs(Median fee)Total validation costs(High fee)Total update/re-validation costs(Low fee)Total update/re-validation costs(Median fee)Total update/re-validation costs(High fee)1,506N/A671,4391,506€1,185€1,675€3,674€2,264€2,624€4,478€1,709,060€2,528,171€4,366,018€3,265,241€3,960,549€5,321,456ConservativeModerateHighMD+IVDTotal costs(Low fee)Total costs(Median fee)Total costs(High fee)Total # of SSCPsProportion of SSCPs destined to HCP and patient# of SSCPs destined to HCP and patientFraction of pages for patientFraction of pages for removal of duplication with IFUCost of drawing up SSCPCost of translationTotal costs (lower)Total costs (median)Total costs (upper)Total saving (lower)Total saving (median)Total saving (upper)€48,282,070€65,037,509€91,181,0147,25216%1,16820%N/A€6,000€50,000€42,000€56,000€70,000€9,813,709€13,084,945€16,356,181MD+IVDTotal saving (lower)Total saving (median)Total saving (upper)€18,272,308€24,363,078€30,453,847Total # of SSPsProportion of SSPs destined to HCP and patient# of SSPs destined to HCP and patientFraction of pages for patientFraction of pages for removal of duplication with IFUCost of drawing up SSPCost of translationTotal costs (lower)Total costs (median)Total costs (upper)Total saving (lower)Total saving (median)Total saving (upper)1,50613%19320%30%€3,000€20,000€17,250€23,000€28,750€8,458,600€11,278,133€14,097,666 
 
 
 
 
Elements of conformity assessment  

Table 6: Change management 

63 

Enterprise size​QMS certificates per company sizeChanges to QMS certificate*LowAverageHighCost savingLowAverageHighMicro​2,8110€0€0€0Small​4,8161€14,449,147€25,286,007€36,122,867Medium​5,0002€30,002,877€52,505,034€75,007,192Large​5,4003€48,601,562€85,052,733€121,503,904Supra-large​6945€10,406,250€18,210,938€26,015,625Enterprise size​TD certificatesChanges to TD certificate*LowAverageHighCost savingLowAverageHighAll7,4382€25,000€52,500€80,00030%€111,570,000€234,297,000€357,024,000Total MDLowerAverageHigher€215,029,835€415,351,711€615,673,587ConservativeModerateHighTotal MD+IVDLowerAverageHigher€246,298,252€477,625,608€708,952,964Cost savingCost savingCost per change for TD€10,000€17,500€25,00030%Cost per change for QMS 
 
 
 
 
 
IVD specific change management: 

These tables estimate the cost savings resulting from the introduction of predetermined change control plans (PCCPs) for changes related to both QMS 
and product certificates. 

-  The total number of QMS certificates per enterprise size for both MDs and IVDs was derived from the tables in Annex III. 
-  The number of changes per year which would currently require notified body assessment, and the estimate of the proportion of costs saved from the 

use of PCCPs was estimated based on industry and expert input. 

-  The range of costs per change was estimated based on notified body and industry data. 

The cost savings were estimated based on conservative, moderate and high scenarios corresponding to the range of costs per change. 

64 

Enterprise size​QMS certificates per company sizeChanges to QMS certificate*LowAverageHighCost savingLowAverageHighMicro​3040€0€0€0Small​5211€1,562,070€2,733,622€3,905,175Medium​4692€2,811,080€4,919,391€7,027,701Large​4653€4,186,934€7,327,134€10,467,334Supra-large​755€1,125,000€1,968,750€2,812,500Enterprise size​TD certificatesChanges to TD certificate*LowAverageHighCost savingLowAverageHighAll1,4392€25,000€52,500€80,00030%€21,583,333€45,325,000€69,066,667Total IVDLowerAverageHigher€31,268,417€62,273,897€93,279,377Cost per change for TDCost savingCost per change for QMSCost saving€10,000€17,500€25,00030% 
 
 
 
Table 7: Surveillance frequency 

This table estimates the cost savings related to the measure on reducing the frequency of surveillance audits.  

The costs of audits broken down by enterprise size were obtained based on data collected from industry, notified bodies and expert input.  

To calculate the current costs of yearly surveillance audits, the above costs were applied to the distribution of QMS certificates per enterprise size from 
Annex III. An adjustment was applied to capture combined activities (such as MDR audits also covering MDSAP audits). 

Three scenarios were estimated to capture the potential cost savings if there would be 10%, 30% or 50% fewer audits every other year. 

65 

Audit cost calculation:Audit costs lowerAudit costs medianAudit cost higherMicro and small7,500 €13,750 €20,000 €Medium25,000 €37,500 €50,000 €Large50,000 €85,000 €120,000 €Micro and small8,45263,391,516 €116,217,779 €169,044,042 €Medium3,69492,351,197 €138,526,796 €184,702,394 €Large3,229161,437,500 €274,443,750 €387,450,000 €Total per year n317,180,213 €529,188,325 €741,196,437 €Corrected due to combined activities (MDSAP etc)253,744,170 €423,350,660 €592,957,149 €Total per year n253,744,170 €423,350,660 €592,957,149 €Total per year n+1 with 10% fewer audits228,369,753 €381,015,594 €533,661,434 €Total per year n+1 with 30% fewer audits177,620,919 €296,345,462 €415,070,005 €Total per year n+1 with 50% fewer audits126,872,085 €211,675,330 €296,478,575 €With 10% fewer audits12,687,209 €21,167,533 €29,647,857 €With 30% fewer audits38,061,626 €63,502,599 €88,943,572 €With 50% fewer audits63,436,043 €105,837,665 €148,239,287 €Savings per year:planning costs + conduct (number of auditors x FTE days) + travel costs + report feesNumber of certificates:Currently:In the future: 
 
 
 
Table 8: Sampling of technical documentation 

66 

Super largeTypical number of categories/ groups in a portfolioCurrent TDs reviewed per category per surveillance (lower)Current TDs reviewed per category per surveillance (median)Current TDs reviewed per category per surveillance (upper)Sampling costsNumber of QMS certs of that class and that mf sizeCurrent costs of surveillance per year (lower)Current costs of surveillance per year (median)Current costs of surveillance per year (upper)MDs5135€36,000382€68,681,250€206,043,750€343,406,250IVDs4135€36,00071€10,152,000€30,456,000€50,760,000Total€78,833,250€236,499,750€394,166,250LargeTypical number of categories/ groups in a portfolioCurrent TDs reviewed per category per surveillance (lower)Current TDs reviewed per category per surveillance (median)Current TDs reviewed per category per surveillance (upper)Sampling costsNumber of QMS certs of that class and that mf sizeCurrent costs of surveillance per year (lower)Current costs of surveillance per year (median)Current costs of surveillance per year (upper)MDs3123€36,0002,970€320,770,307€641,540,613€962,310,920IVDs2123€36,000437€31,485,742€62,971,483€94,457,225Total€352,256,048€704,512,097€1,056,768,145MediumTypical number of categories/ groups in a portfolioCurrent TDs reviewed per category per surveillance (lower)Current TDs reviewed per category per surveillance (median)Current TDs reviewed per category per surveillance (upper)Sampling costsNumber of QMS certs of that class and that mf sizeCurrent costs of surveillance per year (lower)Current costs of surveillance per year (median)Current costs of surveillance per year (upper)MDs3123€36,0002,750€297,028,480€594,056,960€891,085,440IVDs211.52€36,000440€31,708,986€47,563,479€63,417,973Total€328,737,466€641,620,439€954,503,412Micro & SmallTypical number of categories /groups in a portfolioCurrent TDs reviewed per category per surveillance (lower)Current TDs reviewed per category per surveillance (median)Current TDs reviewed per category per surveillance (upper)Sampling costsNumber of QMS certs of that class and that mf sizeCurrent costs of surveillance per year (lower)Current costs of surveillance per year (median)Current costs of surveillance per year (upper)MDs1111€36,0004,195€151,026,421€151,026,421€151,026,421IVDs1111€36,000775€27,904,636€27,904,636€27,904,636Total€178,931,057€178,931,057€178,931,057ConservativeModerateHighConservativeModerateHighSaving factorLowerMedianUpperLowerMedianUpperCurrent costsN/A€938,757,822€1,761,563,343€2,584,368,864€751,006,257€1,409,250,674€2,067,495,092Savings (70%)70%€657,130,475€1,233,094,340€1,809,058,205€525,704,380€986,475,472€1,447,246,564Savings (80%)80%€751,006,257€1,409,250,674€2,067,495,092€600,805,006€1,127,400,540€1,653,996,073Savings (90%)90%€844,882,040€1,585,407,009€2,325,931,978€675,905,632€1,268,325,607€1,860,745,5824 years out of 5-year certificaiton cyclePer year 
 
 
These tables estimate the cost savings associated with removing the routine sampling of technical documentation for review as part of the surveillance 
activities conducted by notified bodies. 

Notified  body,  industry  and  expert  input  were  used  to  determine  the  typical  number  of  device  categories  or  groups  in  a  portfolio,  broken  down  by 
manufacturer size, as well as an average cost of assessing one technical documentation file as part of sampling.  

The number of QMS certificate holders for each enterprise size and device risk class subject to sampling was derived from the distributions in Annex III. 

The cost savings per surveillance year were estimated assuming that between 10-30% of the technical documentation sampling activities would still take 
place as “for-cause” assessments of the notified bodies, i.e. the savings would be between 70% and 90% of current costs. 

The cost saving from reduction in technical documentation sampling during a re-certification year (year 5 in the certification cycle) is taken into account 
in the re-certification calculation below. To avoid double-counting, the above yearly savings are therefore adjusted to cover 4 out of the 5 years of the 
current certification cycle. 

67 

 
 
 
 
Table 9: Unannounced audits 

This table estimates the cost savings resulting from the shift from mandatory unannounced audits to a needs-based, “for-cause” approach. 

The total number of QMS certificates for MDs and IVDs was taken from the distribution tables in Annex II, together with the breakdown by manufacturer 
size. Industry data was used to estimate audit duration, the number of auditors typically involved per audit, and the base audit cost. These parameters were 
used to calculate the total audit cost per manufacturer size under three cost saving scenarios. 

Based on these costs, three  estimated cost savings  scenarios were used  (ranging from 30%  to 70% savings  over a five-year cycle), reflecting varying 
degrees of reduction in unannounced audit activity. 

68 

ConservativeModerateHighNumber certificate holders(QMS MD+IVD)Company sizeNumber of certificate holders by company size (MD+IVD)Audit durationNumber of auditorsAudit base cost (lower)Audit base cost (median)Audit base cost (upper)Audit cost per company size (lower)Audit cost per company size (median)Audit cost per company size (upper)Total (lower)Total (median)Total (upper)Micro+Small8,4521.01€8,690€12,215€17,448€73,449,636€103,239,807€147,478,120Medium5,4691.52€26,070€36,644€52,345€142,576,644€200,403,785€286,276,917Large6,6342.02€34,760€48,858€69,794€230,602,650€324,131,939€463,022,65120,555Per 5-year cycle€446,628,930€627,775,531€896,777,689Per year €89,325,786€125,555,106€179,355,538MD+IVD30% saving€26,797,736€37,666,532€53,806,661Number of respondents3350% saving€44,662,893€62,777,553€89,677,769LowerMedianUpperLowerMedianUpper70% saving€62,528,050€87,888,574€125,548,876Audit fees5,3306,4309,0607,6409,46013,550Weighted average€5,890€7,165€10,148Travel costs2,8005,0507,300Total€8,690€12,215€17,44820,55525€8,690€17,448€12,215MDsIVDs8 
 
 
 
 
Table 10: Replace “re-certification” by “periodic review” and remove general limit of duration of certificates 

69 

Enterprise sizeDistributionQMS certificates (GOEG)Current costs (audit)Cost today (audit)10% savings (Administrative saving)Micro (<10 employed)15%2,671€20,000€53,413,082€5,341,308Small (10–49)26%4,576€50,000€228,778,155€22,877,815Medium (50–249)27%4,750€50,000€237,522,774€23,752,277Large (≥250)29%5,130€75,000€384,762,363€38,476,236Supra large4%659€100,000€65,906,250€6,590,625Total Union wide100%17,786€970,382,624€97,038,262Class IIb impl and IIIEnterprise sizeDistributionTD certificates (GOEG)Current costs (TD)Factor for re-certCost today (TD)10% savings (Administrative saving)50% saving60% saving70% savingMDR TDAll100%7,438€75,00075%€418,387,500€41,838,750€209,193,750€251,032,500€292,871,250MDR QMS (-sampling)MDR TDMDR Total (-QMS sampling)Savings 10%QMS + (10+50%)TD€251,032,500€348,070,762Savings 10%QMS + (10+60%)TD€292,871,250€389,909,512Savings 10%QMS + (10+70%)TD€334,710,000€431,748,262ConservativeModerateHighConservativeModerateHighTotal (MDR+IVDR)QMS sampling (60%)QMS sampling (70%)QMS sampling (80%)Total (lower)Total (medium)Total (upper)Total (lower)Total (medium)Total (upper)€415,237,269€978,491,962€1,072,367,744€1,166,243,526€195,698,392€214,473,549€233,248,705€478,659,352€1,041,914,045€1,135,789,828€1,229,665,610€208,382,809€227,157,966€245,933,122€531,289,769€1,094,544,462€1,188,420,244€1,282,296,026€218,908,892€237,684,049€256,459,205MDR QMS5 year cyclePer year€563,254,693€657,130,475€751,006,257€97,038,262 
 
 
 
 
These tables estimate the cost savings from replacing current re-certification practices with ‘periodic review’. This calculation assumes that current re-
certification activities are merged with annual surveillance for that year and therefore involve an audit and sampling of technical documentation.  

The costs of audits as part of re-certification activities increase with manufacturer size, with the values based on industry data and expert input. 
Conversely, the costs of product certificates are manufacturer size agnostic. Therefore, the distribution of QMS certificates by manufacturer size and the 
total number of product certificates in Annex III were used to determine the total costs of re-certification. 

Audits are likely continuing to happen with the proposed new measure, therefore the estimated cost saving from this aspect of re-certification activity is a 
10% saving related to administrative costs of re-issuing the certificate.  

As regards product certificates, the current cost was assumed to be 75% of the initial cost of certification. The cost saving expected from the lower depth 
of reassessment of technical documentation during periodic review was estimated to range between 50-70%, in addition to the 10% saving in 
administrative costs. 

The contribution to the saving from the sampling of technical documentation is calculated using the costs from Table 8 but applying a lower savings 
range of 60-80% taking into account that there are likely to be additional activities by the notified body (e.g. checking if any new standards are 
consistently applied). These savings are expected to occur once every certification cycle, i.e. every 5 years. Yearly figures are also provided. 

70 

Enterprise sizeDistributionQMS certificates (GOEG)Current costs (audit)Cost today (audit)10% savings (Administrative saving)Micro (<10 employed)15%272€20,000€5,434,134€543,413Small (10–49)26%466€50,000€23,275,408€2,327,541Medium (50–249)27%483€50,000€24,165,067€2,416,507Large (≥250)29%522€75,000€39,144,912€3,914,491Supra large4%67€100,000€6,705,163€670,516Total Union wide100%1,810€98,724,684€9,872,468Class D, C self-test, CDxEnterprise sizeDistribution(Team-NB)TD certificates (GOEG)Current costs (TD)Factor for re-certCost today (TD)10% savings (Administrative saving)50% saving60% saving70% savingIVDR TDAll100%1,439€100,00075%€107,916,667€10,791,667€53,958,333€64,750,000€75,541,667IVDR QMS (-sampling)IVDR TDIVDR Total (-QMS sampling)Savings 10%QMS + (10+50%)TD€64,750,000€67,166,507Savings 10%QMS + (10+60%)TD€86,333,333€88,749,840Savings 10%QMS + (10+70%)TD€97,125,000€99,541,507IVDR QMS€2,416,507 
 
 
Table 11: Periodic safety update reports (PSUR) 

71 

Device class# of unique PSURs reported by 26 NBs (17th NB survey)Adjustment for total number of NBsProportion of Class IIa devicesClass IIa PSURsClass IIb non impl PSURsCurrent cost of update PSUR (lower)Current cost of update PSUR (median)Current cost of update PSUR (upper)Class IIa and IIb non impl2,6479,07980%7,2631,816€25,984,456€31,377,456€45,758,790Class III and impl4,4026,603N/AN/AN/A€36,646,650€47,145,420€109,147,590€62,631,106€78,522,876€154,906,380Cost for updateLowerMedianUpperDevice classFuture cost of update PSUR (lower)Future cost of update PSUR (median)Future cost of update PSUR (upper)Class IIa and IIb non impl€4,770€5,760€8,400Class IIa and IIb non impl€4,330,743€5,229,576€7,626,465Class III and impl€5,550€7,140€16,530Class III and impl€18,323,325€23,572,710€54,573,795Totals€22,654,068€28,802,286€62,200,260Device classCost saving (lower)Cost saving (median)Cost saving (upper)Class IIa and IIb non impl€21,653,713€26,147,880€38,132,325Class III and impl€18,323,325€23,572,710€54,573,795Total (MD)€39,977,038€49,720,590€92,706,120ConservativeModerateHighTotal MD+IVDCost saving (lower)Cost saving (median)Cost saving (upper)€43,215,178€53,697,390€99,435,480 
 
 
This table estimates the cost savings from the simplification measures for PSURs. 

The number of PSURs was based on notified body data and was distributed across device risk classes that require them, in accordance with the distribution 
tables in Annex III. 

The internal manufacturer cost estimates for updating the PSURs were based on expert input and were applied to calculate the current total cost for each 
device class. Estimated future costs were then calculated using the same cost estimate ranges, but with a halved update frequency (or removal for class IIa 
devices). The estimated cost savings were established for both MDs and IVDs under conservative, moderate and high scenarios. 

72 

Device class# of unique PSURs reported by 5 NBs(17th NB survey)Adjustment for total number of NBsCurrent cost of update PSUR (lower)Current cost of update PSUR (median)Current cost of update PSUR (upper)Class C5021,506€4,789,080€5,783,040€8,433,600Class D152456€1,687,200€2,170,560€5,025,120€6,476,280€7,953,600€13,458,720Cost of updateLowerMedianUpperDevice classFuture cost of update PSUR (lower)Future cost of update PSUR (median)Future cost of update PSUR (upper)Class C€3,180€3,840€5,600Class C€2,394,540€2,891,520€4,216,800Class D€3,700€4,760€11,020Class D€843,600€1,085,280€2,512,560Totals€3,238,140€3,976,800€6,729,360Device classCost saving (lower)Cost saving (median)Cost saving (upper)Class C€2,394,540€2,891,520€4,216,800Class D€843,600€1,085,280€2,512,560Total (IVD)€3,238,140€3,976,800€6,729,360 
 
 
Table 12: Analysis of serious incidents 

These tables estimate the cost savings associated with limiting notified body involvement in the assessment of serious incidents. 

-  The  number  of  MD  and  IVD  serious  incident  reports  in  2024  was  collected  from  EEA  national  competent  authorities  (covering  90%  of  EEA 

population for MDs and 70% of EEA population for IVDs). This number was adjusted to cover the total EEA population. 
-  The proportion of serious incident reports that are currently evaluated by notified bodies was provided by notified bodies. 
-  The fees of notified body assessment per report were provided by a report from MedTech Europe48. 

The costs saving estimates are provided in conservative, moderate and high scenarios. 

Note: The notified body fees for in-depth assessment of serious incidents that require further evaluation (e.g., serious incidents of high severity or leading 
to field safety corrective actions) were not taken into account, as these current costs would remain in the future. 

48 MedTech Europe, IVDR & MDR Survey Results 2024, December 2024. 

73 

Total # of reports using EEA numbers as referenceProportion of serious incident reported that get evaluated (17th NB survey)Cost per report (MTE survey) (lower)Cost per report (MTE survey) (average)Cost per report (MTE survey) (upper)Total costs for serious incident reporting (EEA multiplier) (lower)Total costs for serious incident reporting (EEA multiplier) (average)Total costs for serious incident reporting (EEA multiplier) (upper)144,29983.33%€200€400€600€24,049,774€48,099,548€72,149,321Total # of reports using EEA numbers as referenceProportion of serious incident reported that get evaluated (17th NB survey)Cost per report (MTE survey) (lower)Cost per report (MTE survey) (average)Cost per report (MTE survey) (upper)Total costs for serious incident reporting (EEA multiplier) (lower)Total costs for serious incident reporting (EEA multiplier) (average)Total costs for serious incident reporting (EEA multiplier) (upper)4,898100%€200€400€600€979,557€1,959,114€2,938,670ConservativeModerateHighTotal MD+IVDTotal (lower)Total (average)Total (upper)€25,029,331€50,058,661€75,087,992Costs of assessment of individual serious incidents that would not be assessed by notified bodies (IVDs)Costs of assessment of individual serious incidents that would not be assessed by notified bodies (MDs) 
 
 
 
Table 13: Class I reusable surgical instruments and Class A sterile IVDs 

These tables estimate the cost savings associated with removing notified body involvement for class I reusable surgical instruments and class A sterile 
IVDs where manufacturers apply relevant harmonised standards or common specifications. 

The number of QMS certificates for class Ir/s/m MDs and class A IVDs was taken from the certification distribution table in Annex III. 

-  For MDs, the proportion of reusable surgical instruments within class Ir/s/m MDs was derived from the Elenco database49. 
-  For IVDs, the proportion of class As IVDs was from industry data. 

Expert input was used to estimate the current costs, taking into account application fees, assessment and audit costs, certificate decision costs and annual 
fees. These  allowed for  the calculation of  the total  costs currently associated with notified body involvement  and, consequently, the total  cost  savings 
expected under the revised approach for both class Ir MDs and class As IVDs. 

49 Refer to footnote 38. 

74 

Certificate distributionElencoNumber of Class Ir/s/m QMS certificatesProportion of RSI in Class ICost of certificate (lower bound)Average costCost of certificate (higher bound)Total costs (lower bound)Average costTotal costs (higher bound)93674.7%69917,10032,20047,30011,957,12622,515,75833,074,389Certificate distributionNumber of Class As QMS certificatesCost of certificate(lower bound)Average costCost of certificate(higher bound)Total costs (lower bound)Average costTotal costs (higher bound)ConservativeModerateHigh2417,10032,20047,300407,550767,4331,127,31712,364,67623,283,19134,201,706Cost savingsCurrent costsTotal savingsCurrent costsCost savingsNumber of Class I RSI 
 
 
 
Table 14: Technical documentation of near-patient tests 

75 

# near-patient tests# QMS certificates B and C% QMS with near-patient tests# QMS of near-patient testsNear-patient test technical documentation sampled per QMS certificateTotal1,5001,72310%172Per year 3%506Per year 5%759Per year 7%10011TotalCost of technical documentation assessmentCurrent total costFuture total costSavingLower35,000 €52,500,000 €7,444,800 €45,055,200 €Average50,000 €75,000,000 €7,444,800 €67,555,200 €Upper65,000 €97,500,000 €7,444,800 €90,055,200 €Per yearCost of technical documentation assessmentCurrent total cost per year (3%)Current total cost per year (5%)Current total cost per year (7%)Future total cost per year (3%)Future total cost per year (5%)Future total cost per year (7%)Saving (3%)Saving (5%)Saving (7%)Lower35,000 €1,750,000 €2,625,000 €3,500,000 €1,501,840 €2,252,760 €3,003,680 €Average50,000 €2,625,000 €3,750,000 €5,000,000 €2,376,840 €3,377,760 €4,503,680 €Upper65,000 €3,500,000 €4,875,000 €6,500,000 €3,251,840 €4,502,760 €6,003,680 €248,160 €372,240 €496,320 €1.2 
 
 
 
 
 
These tables estimate the cost savings related to the assessment of technical documentation for near-patient tests. 

The  top  table  estimates  the  number  of  near-patient  tests  (taken  from  the  2021  MTE-CAMD  survey50),  the  number  of  corresponding  QMS  certificates 
(assuming that they represent 10% of the total number of QMS certificates for class B and C IVDs), and the number of technical documentation files 
expected to be sampled per certificate. To estimate the yearly saving, the expected number of new near-patient tests per year was calculated assuming they 
could represent 3% to 7% of the total number of near-patient tests on the market. 

The middle table calculates the one-off saving  associated with the transition of  near-patient  tests  to the IVDR. Cost  parameters for  the assessment  of 
technical  documentation  were  based  on  notified  body  data  and  expert  input.  Based  on  these  inputs,  the  current  and  future  total  costs  of  technical 
documentation assessment were calculated for three scenarios. 

The bottom table calculates the analogous yearly saving ranges associated with new near-patient tests placed on the EU market. 

50 MedTech Europe, Survey Report analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in May 2022 when the new EU IVD Regulation applies, September 2021. 

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Table 15: Breakthrough devices 

This table estimates the cost savings from the introduction of an accelerated conformity assessment pathway for breakthrough devices. The estimated cost 
savings represent opportunity costs, deriving from earlier market access. The number of breakthrough-designated devices that could achieve certification 
per year was estimated to be around 80, based on numbers from the US market. Simulations based on representative devices and manufacturer sizes were 
conducted, modelling their price and volumes sold. Opportunity-cost savings were calculated in the conservative, moderate and high saving scenarios.   

77 

ConservativeModerateHighScenarioCase studyProportion of similar BtX# of BtX per yearDevice price (lower)Device price (average)Device price (upper)Average units sold months 1-3 (lower)Average units sold months 1-3 (average)Average units sold months 1-3 (upper)Earlier market access (months) (average)Cost saving for one company (lower)Cost saving for one company (average)Cost saving for one company (higher)Union cost saving (lower)Union cost saving (average)Union cost saving (upper)1Large manufacturer,Class IIb/III implantable(e.g., three chamber implantable pacemaker)30%€3,000€5,000€7,5001,0001,5003,000€9,000,000€22,500,000€67,500,000€222,750,000€556,875,000€1,670,625,0002Medium manufacturer,Class IIb/III non-implantable(e.g., continuous glucose monitor)25%€100€150€2003005001,000€90,000€225,000€600,000€1,856,250€4,640,625€12,375,0003Small manufacturer,Class IIa non-implantable,(e.g., finger-prick glucose measuring)45%€25€50€751,2001,5001,700€90,000€225,000€382,500€3,341,250€8,353,125€14,200,313€227,947,500€569,868,750€1,697,200,313833 
 
 
 
 
Table 16: Fee reductions 

78 

ClassProportion of micro per class# applications from micro per yearProportion of small per class# applications from small per yearCost of conformity assessment (micro)Cost of conformity assessment (small)Factor reduction (micro)Factor reduction (small)Cost savingIr32%24032%412Ir/m/s20%15015%193€15,000€37,500€2,935,012IIa & IIb non impl45%33850%643€42,000€64,500€17,465,565IIb impl2%152%26€71,250€93,750€1,137,878III1%81%13€71,250€93,750€568,939100%751100%1,286€22,107,394ClassProportion of micro per class# applications from micro per yearProportion of small per class# applications from small per yearCost of conformity assessment (micro)Cost of conformity assessment (small)Factor reduction (micro)Factor reduction (small)Cost savingIr20%15020%257Im/s10%7510%129€20,000€50,000€2,358,640IIa & IIb non impl65%48865%836€56,000€86,000€31,640,063IIb impl4%304%51€95,000€125,000€3,034,341III1%81%13€95,000€125,000€758,585100%751100%1,286€266,000€386,000€37,791,629ClassProportion of micro per class# applications from micro per yearProportion of small per class# applications from small per yearCost of conformity assessment (micro)Cost of conformity assessment (small)Factor reduction (micro)Factor reduction (small)Cost savingIr14%10514%180Ir/m/s6%456%77€25,000€62,500€1,768,980IIa & IIb non impl70%52667%862€70,000€107,500€41,555,321IIb impl7%5310%129€118,750€156,250€8,144,991III3%233%39€118,750€156,250€2,844,695100%751100%1,286€54,313,987Lower€61,092,980Average€90,264,855Upper€122,849,584LowerAverageUpperTotal (MD+IVD)50%25%Covered by another measureCovered by another measureCovered by another measure50%25%50%25% 
 
 
These tables estimate the cost savings for reduction of notified body fees for micro and small enterprises, by 50% for micro enterprises and 25% for small 
enterprises. 

The number of micro and small manufacturers estimated in Annex III is further distributed by device risk class. Three scenarios were created to explore 
the impact of variation in the device distributions for micro and small enterprises that require notified body involvement (lower: higher proportion of lower 
risk classes, average and higher – increasing proportions of higher risk classes). 

The cost of conformity assessment per device risk class and company size was based on the costs of audit and the costs of product certificate (for device 
risk classes that require them) as explained in the recertification measure above (Table 10), and the cost of one technical documentation sampling as 
referred to in the measure on sampling (Table 8). 

79 

ClassProportion of micro per class# applications from micro per yearProportion of small per class# applications from small per yearCost of conformity assessment (micro)Cost of conformity assessment (small)Factor reduction (micro)Factor reduction (small)Cost savingAs1%85%71B89%73881%1,150€42,000€64,500€34,039,187C10%8314%199€42,000€64,500€4,946,398D0%00%0€90,000€112,500€0100%829100%1,420€38,985,586ClassProportion of micro per class# applications from micro per yearProportion of small per class# applications from small per yearCost of conformity assessment (micro)Cost of conformity assessment (small)Factor reduction (micro)Factor reduction (small)Cost savingAs1%85%71B80%66380%1,136€56,000€86,000€42,991,544C18%14914%199€56,000€86,000€8,451,843D1%81%14€120,000€150,000€1,029,839100%829100%1,420€52,473,226ClassProportion of micro per class# applications from micro per yearProportion of small per class# applications from small per yearCost of conformity assessment (micro)Cost of conformity assessment (small)Factor reduction (micro)Factor reduction (small)Cost savingAs1%82%28B65%53960%852€70,000€107,500€41,755,076C31%25733%469€70,000€107,500€21,587,313D3%255%71€150,000€187,500€5,193,208100%829100%1,420€68,535,597LowerAverageUpperCovered by another measure50%25%Covered by another measure50%25%Covered by another measure50%25% 
 
 
Table 17: Companion diagnostics (CDx) – Changes to INNs 

This table estimates the cost savings associated with additions of medicinal products with similar characteristics to the intended purpose of a companion 
diagnostic (CDx). 

-  The estimated number of CDx on the EU market was derived from the current number of CDx transitioning to the IVDR, adjusted with a factor 

for the expected number of CDx in the near future, as well as data from the US market. 

-  The typical number of INN additions per device per year was derived from industry input and analysis of data from CDx authorised in the US 

over a period of time. 

-  The estimated cost of an addition of a medicinal product was estimated to be similar to the cost of conformity assessment, with a lower, average 

and upper cost. The fees for the EMA consultation were added. 

The estimated cost savings were calculated for conservative, moderate and high scenarios. 

80 

Number of CDxINN additions per CDx per year Cost of change: conf assessment (lower)Cost of change: conf assessment (average)Cost of change: conf assessment (upper)Cost of change: consultationCost per CDx (lower)Cost per CDx (average)Cost per CDx (upper)Union-wide cost (lower)Union-wide cost (average)Union-wide cost (upper)0.5€58,250€65,750€73,250€4,077,500€4,602,500€5,127,5000.6€69,900€78,900€87,900€4,893,000€5,523,000€6,153,0000.8€93,200€105,200€117,200€6,524,000€7,364,000€8,204,000€56,500€90,00070€60,000€75,000 
 
 
 
 
Cross-cutting simplification, streamlining processes and harmonisation of activities 

Table 18: Early advice and structured dialogue 

These tables estimate the cost savings associated with the introduction of early advice and structured dialogue as support mechanism. 

The calculations for the two tables were analogous. 

81 

Number of CE packages MD5000Number of applications per year MD5000Number of CE packages IVD300Number of applications per year IVD300Total number of CE packages5300Total number of applications5300Proportion:Number:Proportion:Number:New packages15%795New applications15%795Modified packages85%4505Modification applications85%4505New packages going for advice50%397.5New applications going for SD100%795Modified packages going for advice10%450.5Modification applications going for SD10%450.5Total packages going for advice848Savings:Total applications going for SD1245.5Savings:% minor savings 20%169.650,000 €8,480,000 €% minor savings20%249.140,000 €9,964,000 €% moderate savings 60%508.8100,000 €50,880,000 €% moderate savings60%747.3100,000 €74,730,000 €% major savings 20%169.6250,000 €42,400,000 €% major savings20%249.1150,000 €37,365,000 €Total101,760,000 €Total122,059,000 €Reduction for fees:20%Reduction for fees:20%Final:81,408,000 €Final:97,647,200 €New packages going for advice30%238.5New applications going for SD80%636Modified packages going for advice5%225.25Modification applications going for SD5%225.25Total packages going for advice463.75Savings:Total applications going for SD861.25Savings:% minor savings 20%92.7550,000 €4,637,500 €% minor savings20%172.2540,000 €6,890,000 €% moderate savings 60%278.25100,000 €27,825,000 €% moderate savings60%516.75100,000 €51,675,000 €% major savings 20%92.75250,000 €23,187,500 €% major savings20%172.25150,000 €25,837,500 €Total55,650,000 €Total84,402,500 €Reduction for fees:20%Reduction for fees:20%Final:44,520,000 €Final:67,522,000 €Structured dialogue (SD)Early advice 
 
 
The estimated total number of clinical evidence packages (for early advice) was taken from the analysis for the clinical evidence measure above, and the 
number of certificate applications (for structured dialogue), as well as the proportions of packages or applications for new devices vs modified ones were 
estimated from industry and expert input. 

Different scenarios were calculated with different proportions of new and modified packages or certificate applications making use of the early advice or 
structured dialogue, respectively. The savings that could be achieved in individual cases were stratified by minor, moderate and major savings.  

A 20% reduction was applied to account for fees for either mechanism.  

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Table 19: Internationalisation and competitiveness 

This table estimates the cost savings associated with the use of reliance mechanisms such as MDSAP, where a combined MDSAP-MDR audit with separate 
reporting requirements would be replaced by a single MDSAP audit and report. 

The estimated number of manufacturers was taken from the enterprise distribution table in Annex III and combined with the estimated proportion of them 
expected to benefit from MDSAP reliance. For each manufacturer size, the difference between the cost of an MDSAP audit and report and the combined 
cost of an MDSAP and MDR audit and separate reports was used to calculate estimated cost savings under conservative, moderate and high scenarios. 

83 

ConservativeModerateHighEnterprise size# manufacturers (MD+IVD notified body clients)Percentage benefiting from MDSAP# benefiting from MDSAPCost saving* (lower bound)Cost saving* (average)Cost saving* (upper bound)Future savings (lower)Future savings (average)Future savings (upper)Micro3,1155%156€1,090,295€2,492,104€3,893,912Small5,33710%534€3,735,951€8,539,315€13,342,680Medium3,69450%1,847€12,929,168€29,552,383€46,175,599Large3,075100%3,075€21,525,000€49,200,000€76,875,000Supra-large154100%154€1,076,250€2,460,000€3,843,75015,3755,765*Cost saving is the difference between MDSAP audit and MDSAP+MDR audit.Total savings€40,356,664€92,243,803€144,130,941€7,000€16,000€25,000