2019年 5月 23日
TÜV Süd is now the second Notified Body designated to issue CE Mark certifications under the upcoming European Medical Devices Regulation (MDR).
TÜV Süd’s designation covers all Notified Body Operations Group (NBOG) scope codes, but with some minor limitations:
Surprisingly, the designation’s horizontal scope includes MDS 1012 Products without an intended purpose listed in Annex XVI to Regulation (EU) 2017/745, considering that the Common Specifications for Annex XVI of the MDR have not officially been published yet.
TÜV Süd’s designation to the MDR follows that of BSI earlier in 2019.