Sep 27, 2019

Germany’s TÜV Rheinland has received designation to issue CE Mark certificates under the European Medical Devices Regulation (MDR), raising the total number of Notified Bodies with MDR designation to five.

According to the European Commission’s NANDO database, TÜV Rheinland is now the third German Notified Body, along with TÜV SÜD and DEKRA, to be designated under the MDR. Two other Notified Bodies, BSI in the UK and IMQ of Italy, have also obtained designation to certify medical devices under the MDR.

Easing concerns about Notified Body capacity for 2020?

Now that five Notified Bodies are designated to certify under the MDR—albeit with varying degrees of coverage for device types—will manufacturers face less of a capacity bottleneck in terms of NB support before the Regulation comes fully online in May 2020?

As Emergo by UL consultants discussed following IMQ’s designation, not all of these NBs are designated to certify all device types that fall under the scope of the MDR. Furthermore, with the Brexit situation in the UK still unresolved, whether BSI will be a viable option as a European NB partner for manufacturers in the event of a no-deal withdrawal remains in question.

Furthermore, a recent study by KPMG and the Regulatory Affairs Professionals Society (RAPS) found that more than one third of about 230 device manufacturers surveyed foresee NB capacity shortages as a major challenge to full MDR compliance by the May 2020 implementation deadline.

Nonetheless, five designations are better than four, but more progress—that is, more designations—are needed ahead of full MDR implementation to ensure adequate NB availability and European market access for manufacturers.

Additional European medical device regulatory resources from Emergo by UL:

  • EU Medical Devices Regulation (MDR) preparation resource center
  • Brexit transition consulting and in-country representation support
  • On-site MDR training for medical device companies
  • Whitepaper: Understanding Europe’s new MDR
  • Whitepaper: How to select or change your Notified Body