The European Commission has announced that Germany’s TÜV Rheinland is the fifth notified body (NB) to be designated under the Medical Devices Regulation (MDR, 2017/745). The latest version of the NANDO database for the MDR can be accessed here.
A TÜV Rheinland spokesperson advised that “We are accepting applications under MDR. We have also applied under IVDR [in vitro diagnostic regulation]. Our JAT [joint assessment team] audit under IVDR is scheduled to be during the first week of December and we expect to have our designation under IVDR during 2020 summer.”
The announcement of the third German NB to be designated comes as device experts have warned of a pending shortage of available NBs to certify devices, even if the Commission designates 20 notified bodies by next May, which is what is currently being predicted by the Commission.
The other four NBs to be designated are: Italy-based IMQ Istituto, BSI UK, Germany-based TÜV SÜD and Germany-based Dekra Certification GmbH. But for the incoming IVDR, which is set to take effect two years after MDR, no NBs have been designated yet.