Jun 8, 2020

Two Notified Bodies—one based in Germany and the other in Poland—have officially withdrawn from providing CE Mark certifications as Europe transitions to the Medical Devices Regulation (MDR).

All Notified Bodies (NB) officially designated for certification of products and services in the European Union are listed in the NANDO database. Only if they are listed in NANDO can they legally provide their services for CE-marking products. For the MDR ((EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation ((EU) 2017/746 (IVDR)), NANDO has been the source for confirming whether an NB has been designated to the new Regulations. It also lists NBs designated for the Active Implantable Medical Devices Directive (AIMDD) and Medical Devices Directive (MDD) that will be replaced by the MDR in 2021.

AIMDD/MDD to MDR transition

NB designations to the AIMDD and MDD will end in May 2024. This means we can expect to see some NBs drop out of the EU market as that date approaches. The majority of designations related to the current Directives are expected to remain in place for organizations that are also designated under the MDR, but for NBs planning to end support for medical device manufacturers, this is less clear. These NBs will have to leave at some point, and it is likely they will do so well before May 2024.

First two Notified Bodies abandon ship

As could be expected, the original date of application of the MDR, May 26, 2020, was the moment that started the process of NBs leaving. The first such names are now no longer represented in NANDO:

  • ECM-Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH, Germany. Identification number 0481.
  • DQS Polska Sp. z o.o, Poland. Identification number 2282.

Clients of these NBs must move their CE Mark certification to other organizations. Emergo expects that most, if not all, affected manufacturers have already done so. Of course such moves depend on NB availability, as well as acceptance of required documentation as sufficient demonstration of conformity. Emergo consultants have observed that this process does not always run smoothly.

Risks and how to manage them

No CE Mark is certain unless already MDR-certified. Companies should therefore make sure they understand their NBs’ plans regarding MDR designation. If an NB is already designated to the MDR, the risk of sudden loss of certification support is smaller.

NBs not yet designated may soon become so, or they may leave the EU market. Manufacturers should as their NBs about such intentions. If an NB’s answer is not clear, not satisfying or it confirms plans to leave the EU market, manufacturers should start preparing for a move. This starts with a rigorous check on documentation and closing any identified gaps. As a next step, companies may create a list of potential NBs they want to approach. As time progresses and more NBs become designated to the MDR, companies may want to start looking around for new NB partners.

Additional European CE Marking and MDR compliance resources from Emergo by UL:

 

 

Author

  • Ronald Boumans

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