EU MDR RESOURCE
EU MDR strategy and regulatory support for medical device companies pursuing or maintaining CE marking under Regulation (EU) 2017/745.
Regulation (EU) 2017/745 increased expectations for technical documentation, clinical evidence, post-market surveillance, and notified body scrutiny. Companies entering or maintaining the EU market need a clear, resourced plan.
EZ Regulatory helps MedTech teams sequence FDA and EU MDR work so evidence, documentation, and timelines support both markets instead of duplicating effort.
EU MDR is Regulation (EU) 2017/745, the European Union regulation governing medical devices. It defines requirements for CE marking, technical documentation, clinical evaluation, and post-market obligations for devices sold in the EU.
Yes. FDA clearance does not grant EU market access. EU MDR requires its own conformity assessment, technical documentation, and in most cases a notified body review before CE marking.
