After being designated under Regulation (EU) 2017/745 on medical devices in 2020, GMED, a subsidiary of the LNE Group, has just been designated by the French National Agency for the Safety of Medicines and Health Products (ANSM) as a notified body under Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The new European regulation on medical devices (MD) and on in vitro diagnostic medical devices (IVDMD) significantly strengthens some requirements to improve the safety and health of patients and users and to improve harmonization of the application of rules within the European Union. Following the implementation of Regulation (EU) 2017/745 on May 26, 2021 Regulation (EU) 2017/746 for in vitro diagnostic medical devices will enter into force in 2022.
It is under this new regulation that GMED has just been designated as a notified body with a scope of designation covering all designation codes according to Annex II of the Implementing Regulation (EU) 2017/21851.
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 entry into force of Regulation (EU) 2017/746 on May 26, 2022 and in order to respond 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.
1 The scope of the GMED designation is available on the European Commission's information system New Approach Notified and Designated Organisations : NANDO