GMED designated under Regulation (EU) 2017/746 on in vitro diagnostic medical devices

GMED (CE 0459) has just been designated as a Notified Body under Regulation (EU) 2017/746 by the French National Agency for the Safety of Medicines and Health Products (ANSM) with a scope of designation covering all designation codes according to Annex II of the Implementing Regulation (EU) 2017/2185*.

With this new designation, GMED is authorized as of August 20, 2021 to provide certification services to manufacturers according to Regulation (EU) 2017/746.

With the Regulation (EU) 2017/746 entry into force on May 26, 2022, and in order to respond to the strong growth in requests for conformity assessment, GMED continues to deploy its development strategy by investing in expert resources, accelerating the digitization of its tools and processes, while consolidating its methodology for supporting each certification project in order to offer an optimized service to its customers and future customers.

In accordance with the transitional provisions, GMED will continue to enable manufacturers to maintain, in an adequate way, in the European market in vitro diagnostic medical devices covered by certificates of conformity to Directive 98/79/EC until May 26, 2024.

GMED and all its teams remain fully committed to making the transition to the new regulations a success for all.

* The scope of GMED’s designation can be consulted on the European Commission’s information system New Approach Notified and Designated Organisations: NANDO