In few months, the European Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed by Regulation (EU) 2017/745, of which the date of application have been postponed to 26 May 2021.

The goal of the Regulation is clear, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures a high level of safety and health protection whilst supporting innovation.

In particular, in order to ensure a high level of safety and health protection, regulatory requirements relating to clinical investigations, clinical evaluation, vigilance, market surveillance, transparency and traceability of medical devices have been considerably strengthened.






Find an answer to the challenges you are facing in one of our upcoming events: trainings, webinars, forums...

Learn more