GMED Guides

The purpose of this medical device change notification guide, developed by GMED, is to provide guidance on when and how (...)

Commission Implementing Regulation 2017/2185 establishes the codes assignment MDR framework. This framework defines notified bodies’ scope of designation for medical (...)

EUDAMED becomes mandatory on 28 May 2026, with four modules now declared fully functional by the European Commission. This marks (...)

Thinking about transferring your certification to GMED? Our comprehensive certification transfer guide is designed to make your certification transfer simple, (...)

This guide presents the key stages of the EU MDR certification process under Regulation (EU) 2017/745 set up by GMED. (...)

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the (...)

The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation and (...)

This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)

This guide is related to the CE marking according to the directive 98/79/EC and does not apply in the framework (...)