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).
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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