May 23, 2019

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:

  • Scope code MDN 1104 Non-active soft tissue and other implants: Annexes X and XI without breast implants
  • Scope code MDT 2013 Devices which have undergone reprocessing: Only for medical devices that are foreseen by the manufacturer to undergo reprocessing

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.

Related European MDR and Notified Body information from Emergo by UL:

  • On-site EU Medical Devices Regulation (MDR) training for manufacturers
  • Medical device classification consulting for Europe
  • CE Mark training for EU medical device regulations
  • Webinar: How to select or change your European Notified Body
  • Whitepaper: Understanding Europe’s new MDR