Tag: UK Responsible Person

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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UK Medical Device Regulation - www.omcmedical.com

UK Medical Device Regulation

United Kingdom Medical Device Regulations UK – Medical Device Requirements UK MDR Role of MHRA Perform market surveillance of medical devices on UK market and will be able to take decisions over the marketing and supply of device in the UK. Responsible for designation and monitoring of UK conformity assessment bodies. UK Approved Bodies From […]
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April Newsletter

EU REGULATIONS Factsheet for Class I – Medical Devices | 28 April 2021 European commission published a Factsheet for Class I- Medical Devices based on MDCG 2019-5 rev. 1.for class I medical device manufacturers. It summarizes the necessary steps to ensure the compliance ofclass I medical with applicable requirements of the EU-MDR 2017/745. The class […]
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