Category: Medical Device Regulation

Switzerland Medical Device Regulations - www.omcmedical.com

Switzerland Medical Device Regulations

Switzerland Market Situation As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA) No barrier free access to the EU internal market Swiss has been downgraded to the third country Swiss manufactures has stricter requirements when exporting their medical devices to the EU. The Swiss MedTech […]
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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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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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