News about GMP/cGMP

11.10.2019

EC: Dekra becomes first Notified Body according to IVDR

On 10 October 2019, the European Commission announced the first Notified Body designated under the EU Vitro Diagnostics Regulation (IVDR).

It is the German Dekra Certification GmbH, which now also appears in the official database NANDO of the European Commission. In August, Dekra was already designated as the third Notified Body under the EU Medical Device Regulation (MDR) (we reported).

Source:

EC: IVDR NANDO



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