Clinical evaluation in the era of Regulation (EU) 2017/745

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Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed by Regulation (EU) 2017/745, of which the date of application have been postponed to 26 May 2021.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

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