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MDR GUIDANCE

6th and 7th MDR Notified Body designated

November 5, 2019

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
Email : info.nl@bsigroup.com
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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This guidance provides a very useful timeline with all the deadlines for MDR manufacturers to plan of and to be able to target the gaps and address them ahead of time in order to be fully compliant with MDR.