Tag: Medical Device Registration

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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August Newsletter

EU REGULATIONS Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20 August 2021 This guidance is intended to aid notified bodies to implement requirements established by MDR and IVDR about certification activities to be carried out according to Article […]
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July Newsletter

EU REGULATIONS MDCG 2021-23 – Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746| 20 August 2021 Notified bodies providing certifications to certify that the quality management system of the distributor or importer complies with the requirements laid down in the […]
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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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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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Switzerland Authorised Representative - www.omcmedical.com

Switzerland Authorised Representative

Switzerland Medical Device Regulations Medical devices are regulated by : Swiss Agency for Therapeutic Product Manufacturer Responsibility Ensuring medical device placed on the market is in accordance with the requirement of the medical device ordinance. Affixing the conformity mark and carrying out clinical evaluation according to Article 61 EU MDR. Keep technical documentation, declaration of […]
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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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