Oct 14, 2019

It had already been hinted at the MDCG Stakeholders meeting of September 30th, 2019, but now it is official: DEKRA Certification GmbH in Germany (DEKRA) is the first Notified Body officially designated for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).

Scope

Under its new designation, DEKRA can certify conformity assessments based on Annex IX(I) (Quality Management) and IX(II) (Assessment of the Technical Documentation) of the IVDR; Annexes X (Type Examination) and XI (Production Quality Assessment) are not covered by their scope. Within this limitation of procedures, almost all device codes and horizontal codes are covered. These are the exceptions:

  • IVR 0403, Other devices intended to be used for human genetic testing, is not covered.
  • IVD 4010, In vitro diagnostic devices which require knowledge regarding mycology, is not covered.
  • IVR 0505, Devices intended to be used to grow / isolate / identify and handle infectious agents, is limited to devices to be used to identify and handle infectious agents.

Certification

Only after receiving official MDR or IVDR designation can a Notified Body start issuing quotations, which is the start of the full CE Mark certification process. Such a process can take six to nine months, but longer certification timeframes are also possible. It may take until February 2020 before the first audits take place, so we may be well into 2020 before the first IVDs are certified under the new Regulations.

Extra time for IVDs

The transitional period for IVDs to become certified under the new IVDR started in May 2017, together with the Medical Devices Regulation (EU) 2017/745 (MDR). However, instead of a three years’ transitional period for the MDR, the IVDR allows for a five years’ transitional period.

With the first Notified Body designated for the IVDR not too long after the first Notified Bodies being designated for the MDR, it looks like more time has been granted for IVD manufacturers to be certified. The European Commission, as well as TEAM-NB and NB-MED, suggested at the September 2019 MDCG stakeholders meeting that soon more Notified Bodies would be designated for the IVDR. This suggests these manufacturers could be facing less of a bottleneck compared to manufacturers pursuing CE Marking under the MDR.

However, a study by the Dutch National Institute for Public and Environment (RIVM) shows that currently about seven percent of IVDs require Notified Body certification, but that will jump to 84% under the IVDR. This not only means a huge increase of work for the Notified Bodies, but also requires an huge investment in testing and preparation of documentation by the manufacturers. Figures from the European Commission suggest at this moment 10 other Notified Bodies are still in the process of designation for the IVDR. Even if all of these entities obtain designated soon, it is not clear if all IVDs currently placed on the EU market will be able to obtain certification in time.

Additional European IVDR regulatory resources from Emergo by UL: