News about GMP/cGMP

27.05.2019

TÜV SÜD designated as second Notified Body for MDR

TÜV SÜD Product Service was designated by the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) as the second Notified Body for the EU Medical Devices Regulation (MDR).


This allows TÜV SÜD besides the British Standard Institution (BSI) to certify manufacturers according to the MDR.
The MDR came into force in May 2017 and applies to all manufacturers who wish to bring medical devices to the European market. The transitional period shall end on 25 May 2020. According to MedTech Europe, about 20 Notified Bodies are expected to be designated under the MDR by the end of 2019.

Source:

TÜV SÜD Press Release


 

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