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Second Notified Body is designated and notified under the new EU Medical Device Regulation

23/5/2019

Congratulations to TÜV SÜD Product Service GmbH Zertifizierstellen in Germany which has become the second Notified Body to be designated and notified under the EU Medical Devices Regulation (MDR).  With the BSI UK, they are now listed in the European Commission's New Approach Notified and Designated Organisations (NANDO) database.

 

Apparently, the procedure took around 18 months and they've still to be designated under the new EU IVD Regulation (IVDR).

 

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