New MDR And IVDR Implementing Acts Due Imminently
Common specifications, Eudamed arrangements and EU reference laboratories are all topics that should be addressed in EU legislative acts to assist with the implementation of the new medtech regulations.
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Medtech companies accessing the EU market must be fully compliant with the new Medical Device Regulation by 26 May 2024 – but the regulatory structure is incomplete and companies also have the ongoing pandemic to contend with.
Expert panel review of clinical files for high-risk IVDs are happening for the first time under the new EU IVD Regulation.
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussion at the Council of the EU have now added to this drive.