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Regulatory Focus™ > News Articles > 2019 > 9 > TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

Posted 26 September 2019 | By Zachary Brennan 

TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

The European Commission on Thursday announced that Germany’s TÜV Rheinland is the fifth notified body (NB) to be designated under the EU’s Medical Devices Regulation (MDR).

A TÜV Rheinland spokesperson told Focus that beginning tomorrow, "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 when MDR takes effect.

The other four NBs to be designated are: Italy-based IMQ IstitutoBSI 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.


Updated on 9/26 with comment from TÜV Rheinland.

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