Jun 19, 2020
German Notified Body TÜV SÜD has obtained designation to issue CE Mark certificates under the European In-vitro Diagnostic Medical Devices Regulation (IVDR).
There are now four Notified Bodies designated to the IVDR ahead of the Regulation’s May 2022 date of application, according to the NANDO database:
Given that the percentage of IVD devices anticipated to require CE Marking from Notified Bodies will increase from less than 10% currently to more than 80% under the IVDR, TÜV SÜD’s designation should come as welcome news—so long as significantly more Notified Bodies follow suit to support manufacturers’ IVDR compliance.
First European Notified Body designated to issue CE Marking under IVDR announced