Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector. In this context, the European Commission opened a call for evidence on 8 September 2025 on the targeted revision of the EU rules for medical devices and IVDs.
Aims of the MDR and IVDR revision
Unpredictable certification timelines, disproportionate requirements, and diverging practices across the EU may lead manufacturers, particularly small and medium enterprises, to discontinue the supply of medical devices or delay their launch. In addition to potentially harming the competitiveness of the EU medical device market, discontinuations and delays can also adversely impact patient care and public health.
The revision aims at simplifying, streamlining, and optimising the regulatory framework, while maintain the overall structure of the regulations and keep preserving public health and patient safety at its core. Specifically, the initiative intends to:
- reduce the administrative burden including reporting obligations;
- improve the predictability and cost-efficiency of the certification processes;
- make the conformity assessment requirements more proportionate, especially for low- and medium-risk devices as well as for special patient needs’ devices;
- empower digitalisation;
- streamline procedures including those on governance;
- allow the sector to benefit from international cooperation including reliance (where appropriate);
- better align the regulatory framework with other relevant legislation.
Have your say: stakeholders invite to submit their feedback
Stakeholders from the medical device sector – especially SMEs – are invited to share their view. Feedback can be submitted here until 6 October 2025 in any EU language. Moreover, organisations, researchers, and societies with expertise in medical devices are invited to submit relevant data.
This initiative will have a significant impact on manufacturers and other economic operators. The outcome will likely be a proposal for a Regulation published by end of this year.
Do you have any questions regarding the upcoming restrictions? Get in touch!
References:
European Commission (2025). Call for Evidence, Medical devices and in vitro diagnostics – targeted revision of EU rules. Retrieved on 09/09/2025.
Simona Varrella
Regulatory Intelligence & Innovation Department
26/09/2025
Leave a Reply