The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations for importers and distributors under MDR and IVDR Regulations
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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
