EU MDR (Regulation 2017/745)

The EU Medical Device Regulation sets safety and performance requirements, technical documentation, clinical evidence, post-market surveillance and the role of notified bodies for devices placed on the Union market.

A quality system that meets ISO 13485 is the usual way a manufacturer shows it can keep meeting those requirements. The regulation itself asks for a QMS appropriate to the device, plus technical documentation, a clinical evaluation, UDI, and post-market work such as PMS, PMCF and vigilance. Class and conformity route decide how much a notified body is involved.

Selling in more than one market means the quality system has to support the rules of each market. HAVGATE can sample EU MDR evidence in an audit session. It does not write a technical file, a clinical evaluation report or a declaration of conformity for you.