Tag: Local EU listing

October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic […]
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June Newsletter

EU Regulations European Medical Device Nomenclature (EMDN) – Questions and Answers | 15 June 2021 European commission (MDCG) published a question and answers article for European Medical Device Nomenclature (EMDN). European Medical Device Nomenclature (EMDN) supports the functioning of the European database (EUDAMED). EMDN will be used for registration of medical device in EUDAMED by […]
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EU Medical Device Regulation - www.omcmedical.com

EU Medical Device Regulation

European Union Medical Device Regulations EU – Medical Device Regulations EU MDR Responsibilities of Authorised representative • When a device manufacturer is established outside of the European Union, the manufacturer needs to appoint an authorised representative to place the medical device in one of the member states. An Authorized Representative is any person naturally or […]
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