COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE EVALUATION on the Targeted evaluation of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Medicines Agency, exchange of information, harmonisation of standards, market approval, medical device, medical diagnosis, public health, quality standard, safety standard, smart technology

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   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  SWD(2025) 1052 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE EVALUATION  on the Targeted evaluation of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices Accompanying the document Proposal for a   REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying  and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I  {COM(2025) 1023 final} - {SWD(2025) 1050 final} - {SWD(2025) 1051 final}  
 
 
1.  Context  

Medical  devices  and  in  vitro  diagnostic  medical  devices  (IVDs)  are  crucial  for  healthcare, 
providing essential solutions to help diagnose, prevent, and treat diseases. In Europe, there are 
over 2 million medical technologies, including X-ray machines and pacemakers and IVDs such 
as HIV and pregnancy tests, play a key role in clinical decision making. In 2025, the European 
medical device market is estimated at approximately 170 bn EUR, making it the second largest 
in the world.  Since the 1990s, EU rules have existed to ensure safe and performant devices are 
available to patients. In 2017, two EU Regulations replaced three Directives under which safety 
crises arose, to create a strengthened and more sustainable framework, protecting patient health 
whilst supporting innovation.  

Challenges in transitioning to these Regulations led to extended transition periods for devices 
moving  from  the  Directives  to  the  Regulations  to  mitigate  the  risk  of  shortages  and 
implementation delays, exacerbated by the COVID-19 pandemic. 

2.  The Targeted Evaluation  

While an evaluation is legally required by May 2027, in light of the above, the Commission 
initiated a targeted evaluation of the Regulations in 2024, covering the period  between their 
adoption on 5 April 2017 and 31 December 2024. Whilst implementation is still on-going, it 
has  assessed  how  the  EU  Regulations  on  medical  devices  are  performing  to  date  and  in 
particular  the  impacts  on  device  availability,  innovation,  costs  and  administrative  burdens, 
especially  for  SMEs.  The  analysis  covers  whether  the  Regulations  are  so  far  effective  in 
meeting  their  objectives,  cost-efficient,  coherent  to  other  EU  legislation  and  fit  for  purpose 
whilst bringing EU added value. The findings are based on a broad evidence base but are subject 
to limitations on data availability and a cost-benefit quantification.  

3.  Key findings 

The evaluation found that while the EU Regulatory framework benefits from a more robust 
infrastructure  for  safe  and  performant  medical  devices,  it  is  not  always  effective  in 
achieving  its  objectives.  Furthermore,  implementation  delays,  increased  administrative 
burdens,  and  inconsistent  application  of  requirements  have  revealed  shortcomings  and 
structural inefficiencies leading to unpredictability, reduced device availability and impacting 
competitiveness.  

Whilst  the  Regulations  have  brought  benefits  for  patients,  through  stronger  safety 
requirements  and  oversight  mechanisms,  compliance  costs  are  disproportionate  and 
unevenly  distributed,  particularly  affecting  SMEs  and  niche  device  manufacturers. 
Streamlining  procedures,  reducing  administrative  complexity,  along  with  more  flexible 
regulatory pathways would help balance regulatory burdens against public health gains. 

Whilst the MDR and IVDR are generally coherent with one another, stakeholders highlighted 
the  need  to  avoid  contradictory  requirements  or  overlaps  in  their  coherence  with  other  EU 
digital,  environmental  and  health  legislations.  The  Regulations  offer  EU  added  value  by 
providing  a  unified  framework  over  individual  national  laws,  preferred  by  stakeholders  for 

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improved  consistency  and  potential  cost-efficiency.  Finally,  while  the  Regulations  remain 
relevant  to  their  objectives  of  ensuring  patient  safety,  public  health  protection,  and  market 
functioning, challenges in innovation, technological development, and competitiveness indicate 
the need for targeted adjustments to better align with evolving market realities.  

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