Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).

Delegated acts and implementing acts are instruments of the European Commission to ensure the implementation of the EU MDR.

Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.

Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.

You have to do with medical software and feel lost in regulation? Don’t give up. Get guidance with our latest book.

Learn in our workshop how to introduce a system of UDI unique device identification for the traceability of medical devices as a project in your company.

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