European Commission Proposes to Extend Deadlines for IVDs

The European Commission published a proposal to amend 2017/745 (MDR) and 2017/746 (IVDR) on January 23rd 2024 to allow an extension for IVDs and update compliance dates to EUDAMED. 

What are the proposed extension and updated compliance dates?

For Class C & D IVDs, the current date is 26 May 2025, and the proposal is to extend Class C to December 2028 and Class D to December 2027. Additionally, they have proposed that Class A and Class B are extended to December 2029. Certain conditions will need to be met just like for MDR, so this isn’t a blanket, all-encompassing free for all. 

For EUDAMED, they are proposing that compliance is as a module is released rather than the current provision which makes EUDAMED mandatory only once all the modules are released. The new proposal, if accepted, could make compliance mandatory in late 2025. 

Please see the full proposal here. 

The European Commission also published a factsheet which can be viewed here. 

While there haven’t been any new updates to this proposal, we will continue to monitor the report closely and provide timely updates as soon as any new information is announced. 

If you need help with the MDR/IVDR, or achieving compliance, please contact us. Our regulatory experts are ready to help you. 

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