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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