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EC: Targeted Revision of MDR and IVDR

The European Commission (EC) has published a call for evidence on the medical device and in vitro diagnostic regulations (MDR/IVDR). The initiative aims to simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate. The overall structure of the current regulatory framework will be maintained.

More specifically, the initiative aims to:

  • reduce the administrative burden including reporting obligations;
  • enhance the predictability and cost-efficiency of the certification processes of notified bodies;
  • make the conformity assessment requirements more proportionate, especially for low- and medium-risk devices and those that cater to special patient needs;
  • enable further digitalisation;
  • streamline procedures including those on governance;enable the EU medical device sector to benefit from international cooperation including reliance, where appropriate;
  • better align the regulatory framework with other relevant legislation.

The feedback period will end on 6 October 2025.


Source:

EC: Published initiatives - Medical devices and in vitro diagnostics – targeted revision of EU rules


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