Tag: Medical Device Consultancy

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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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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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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