GMED Guides
Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745
It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the (...)
Changes to medical device and/or quality management system: when and how to submit a request?
The purpose of the guide, prepared by GMED, is to clarify when and how to submit a change application for (...)
Biological assessment of medical devices according to the ISO 10993-1 standard
The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation and (...)
Application request for CE marking certification – Regulation (EU) 2017/745
This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)
Application request for CE marking certification – Regulation (EU) 2017/746
This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)
Codes assignment referred to in the implementing Regulation 2017/2185 in the context of a request for certification according to the Regulation (EU) 2017/745
Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices under (...)
How to change your Notified Body to GMED in 8 steps
Within the constantly changing regulatory framework and in view of uncertainties regarding the future of certain notified bodies, more and (...)
CE Marking of In Vitro Diagnostic Medical Devices
This guide is related to the CE marking according to the directive 98/79/EC and does not apply in the framework (...)
This guide is related to the CE marking according to the directive 98/79/EC and does not apply in the framework of the Regulation (EU) 2017/746.