GMED SAS, which is based in France, has been assigned as the sixth notified body under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which fully applies from 26 May 2022, and its listing appears on the European Commission Nando database of notified bodies.
IVD manufacturers have been urged to get their products assessed under the IVDR without delay. Unfortunately, only a small amount can profit from the grace period, where their products are still in compliance with the IVD Directive (IVDD) until 26 May 2024, under certain conditions. 85% of products will have to comply with the 2022 deadline, and blockages are expected.
GMED SAS has been designated for a very wide range of IVDs, together with a long list of horizontal technical competencies. It is already designated under Regulation (EU) 2017/745 on medical devices (MDR) and was assigned as a notified body under In-vitro diagnostic directives.