MDR Corrigendum - Medical Device Regulation

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MDR Corrigendum

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MDR Corrigendum

https://www.europarl.europa.eu/plenary/en/infos-details.html?id=17721&type=Flash

MDR

MDR – Corrigendum 1 – Minor Correction

MDR – Corrigendum 2 – Class I

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amendement and the UDI system annex ANNEX I ANNEX I - General Safety and performance requirements ANNEX VI assessment assessment procedure authorities CE CE marking certificate Chapter I Chapter II Chapter III clinical clinical evaluation clinical investigation clinical investigations conformity conformity assessment core data elements to be provided to the UDI database together with the UDI-DI in accordance with articles 28 and 29 designation electronic electronic system evaluation general requirements general safety General Safety and performance requirements importers market mdr notified bodies performance requirements post-market post-market surveillance procedure registration requirements review safety technical documentation UDI UDI database UDI system

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