6th and 7th MDR Notified Body designated

The European Commission announced two more Notified Body designations under the Medical Device Regulation in the last two days:

DARE!! Services B.V.
Vijzelmolenlaan 7
NL-3447 GX Woerden
Country : Netherlands

Phone : +31(0)348 430 979
Fax : +31(0)348 430 645

Email : certifications@dare.nl
Website : www.dare.nl

Notified Body number : 1912

 

The scope of the accreditation under the MDR can be found on the following link.

BSI Group The Netherlands B.V.
Say Building, John M. Keynesplein 9, 1066 EP
Amsterdam
Country : Netherlands

Phone : +31 (0)20 346 07 80
Fax : –

Email : info.nl@bsigroup.com
Website : –

Notified Body number : 2797

 

The scope of the accreditation under the MDR can be found on the following link.

Check other Notified Bodies already designated under the MDR – on NANDO database. 7 in total at the current date.

We heard at RMD conference last week that the European Commission is planning to have designated 20 Notified Bodies by end of the year/beginning of next year!

Despite these numbers, both Notified Bodies and the industry stated last week that these numbers are still too low for the expected workload coming with the new Regulation.

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