Aug 14, 2019

DEKRA Certification GmbH, NB number 0124, is now designated for the Medical Devices Regulation (EU) 2017/745 (MDR).

DEKRA’s designation is now published in Nando.  DEKRA is the third Notified Body (NB) to be designated, after BSI Assurance UK Ltd and TÜV SÜD Product Service GmbH. BSI is currently not recommended as an NB because of the very high risk of the UK leaving the EU under a no-deal Brexit scenario on October 31st, so DEKRA is for now the second option for companies who want to certify under the MDR.

Scope of DEKRA’s designation

DEKRA is designated for a broad scope of the NBOG codes under the MDR, but is not a full-scope NB. Manufacturers should therefore verify their needs within the scope for which DEKRA is designated.

In short, DEKRA is designated for Annexes IX (I and II) and XI(A), although not all Medical Device Nomenclature (MDN) Codes are covered by Annex IX(II). Active implantable devices are not in the scope of DEKRA. The same goes for IVF and ART, aesthetic breast implants and devices for ingestion. DEKRA expects designation for the IVDR “soon,” which confirms the company’s ambition for the IVD field.

Certification under the MDR

A DEKRA spokesperson said they hope they can start the first audits for the MDR in November 2019. That is exactly six months before the date of application of the MDR. This does not give much time for companies to be certified as the realistic estimate for these processes is that they take six to nine months.

Too little, too late?

With the designation of DEKRA there are now effectively two NBs designated for the MDR. As of  August 2019, there are nine months to go until the date of application of the MDR. Many devices need MDR certification if they are to be placed on the market after that date. These include reusable surgical instruments, software and devices depending on embedded software, accessories of devices intended for cleaning, disinfecting and sterilizing of medical devices, etc. It is far from certain all these devices can be certified in time, and therefore the availability of devices after May 2020 may be impacted.

Related European MDR and CE Marking information from Emergo by UL: