Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.

The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.

Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.

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.

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