GMED designated under Regulation (EU) 2017/745 on medical devices

GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency for Medicines and Health Products Safety (ANSM).

Equipped with this designation since July 8, 2020 GMED has mobilized its teams to offer manufacturers with certification services according to the Regulation (EU) 2017/745 for a field of medical device categories among the broadest*.

Simultaneously, during the transition period, GMED gathers all the necessary resources to allow manufacturers to maintain, in a suitable manner, on the European market, the medical devices covered by certificates of conformity under the Directives 90/385/EEC and 93/42/EEC.

In deployment of its development strategy, GMED consolidates its support methodology for each certification project to provide a service of Excellency to its current and future customers.

To complement its MDR designation approach, GMED is determined to succeed in the best possible timeframe, its designation under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

GMED and all of its teams remain fully invested for the transition to the new Regulations to be a success for all.

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