GMED Guides

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 guide is designed to make your transition simple, secure, and seamless, (...)

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

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

The purpose of the guide, prepared by GMED, is to clarify when and how to submit a change application for (...)

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) (...)

Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices under (...)

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