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Regulatory Focus™ > News Articles > 2019 > 11 > First Netherlands-Based Notified Body Designated Under MDR

First Netherlands-Based Notified Body Designated Under MDR

Posted 05 November 2019 | By Zachary Brennan 

First Netherlands-Based Notified Body Designated Under MDR

The European Commission on Tuesday announced that Netherlands-based notified body (NB) DARE!! Services B.V. has been designated as the sixth NB under the incoming Medical Devices Regulation (MDR).

DARE!! is designated to certify certain active non-implantable devices under MDR and was also previously designated under the Medical Devices Directive.

The other five NBs to be designated are: Germany’s TÜV Rheinland, Italy-based IMQ IstitutoBSI UK, Germany-based TÜV SÜD and Germany-based Dekra Certification GmbH.

The designations, which have been announced at a steady rate since the beginning of the year, comes as device experts have warned of a pending shortage of NBs to certify devices, even if the Commission designates 20 notified bodies by next May, which is when MDR takes effect.

Similar shortage concerns have been discussed for the In Vitro Diagnostic Regulation, which takes effect two years after MDR, as just two NBs have been designated so far.


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