Inhalt

Guide to MDCG Document 2020-6

Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC

With the document MDCG 2020-6, the Medical Device Coordination Group addresses the widely debated topic of "sufficient clinical data" for so-called legacy devices, and provides guidance on how to navigate the resulting regulatory requirements.

We at novineon CRO GmbH have prepared a free summary of this document for you, highlighting its most important statements.

This guide provides you with the perfect foundation for developing an MDR-compatible strategy for your legacy devices – together with novineon CRO.

Contact

novineon CRO GmbH
Friedrich-Miescher-Straße 9
72076 Tuebingen, Deutschland

Tel: +49 7071 98979 – 130
Fax: +49 7071 98979 – 230
info@novineon.com

Please calculate 8 plus 8.