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European Commission publishes harmonised standards in support of the MDR and IVDR

European Union - January 12 2022 The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in…

Nikoleta Kyriazopoulou, Grégoire Paquet

European Commission adopts a Regulation on electronic instructions for use for MDR-covered devices

European Union - January 6 2022 The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain…

Nikoleta Kyriazopoulou

Revision of the EU general pharmaceuticals legislation - public consultation is now open

European Union - September 28 2021 The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This…

Claudia Mendes Pinto

MDCG guidance on QMS certification of distributors/importers relabeling, repackaging medical devices

USA - September 22 2021 In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with…

The EC publishes an inception impact assessment for the proposal of a European Health Data Space

European Union - January 19 2021 The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space…

Silvia Lopez Arnao