Regulatory Affairs

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2019/01/07 - Regulatory Affairs - Updated: 2021/04/16 - Thorsten Prinz

CJEU Top Court Cases on Medical Devices

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

footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification

Medical Device Certification Based on the New EU MDR: a Step by Step Guide

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