MDCG guidance: what it is and why it is essential

by Elisa | Mar 15, 2026 | Regulatory Refeference

MDCG (Medical Device Coordination Group) guidance documents are official EU publications that support the practical interpretation of the MDR/IVDR. They are not legally binding, but they represent a key technical reference for manufacturers, notified bodies and other...

MDR 2017/745: a clear overview of the European Medical Devices Regulation

by Elisa | Mar 15, 2026 | Regulatory Refeference

Regulation (EU) 2017/745 (MDR) is the legal framework that governs all medical devices placed on the European market today. Fully applicable since 26 May 2021, it replaced Directive 93/42/EEC (MDD), introducing significantly more stringent requirements in terms of...