The amending regulation also modifies Article 59 of the MDR to allow the immediate application of the Union-wide emergency procedure in the context of the COVID-19 pandemic. Recently, the European Commission (Commission) communicated guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 (Guidelines).
In addition, the Commission’s Medical Device Coordination Group (MDCG) issued key guidance on safety reporting in clinical investigations of medical devices under the MDR. This Sidley Update highlights the key aspects of these new important guidelines.
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