The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
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Jul 21
Artificial intelligence and medical devices: The potential impact of the proposed Artificial Intelligence Regulation on medical device software
The recent proposal for a regulation on artificial intelligence (the Artificial Intelligence Regulation) might add a new piece to the regulatory puzzle governing medical device software and other medical devices that incorporate software based on AI algorithms.
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Jun 21
Mutual recognition for medical devices between the EU and Switzerland ceased to apply on 26 May 2021: what is the impact for the sector?
Interview to Anna Gottret, Alisa Burkhard and Sophie Winkler of Flying Lawyers, Zurich
10
Jun 21
New FAQ on the European Medical Device Nomenclature (EMDN) to support the EUDAMED
The Medical Device Coordination Group (MDCG), composed of representatives of all Member States and a representative of the European Commission, endorsed a new FAQ on the European Medical Device Nomenclature (EMDN)
