January 14, 2022
An interesting fact was overlooked in the headlines last year: Since November 5, 2021 a new Notified Body has been designated for the In-Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD): CeCert Sp. z.o.o. (CeCert).This is a Polish organization, based in Warsaw and they are identified by NB 2934. This is the second Polish Notified Body designated under the IVDD, along with PCBC. The scope of designation for CeCert covers almost all types of device categories recognized under the IVDD, but none of the horizontal scopes. CeCert is not designated for any other European Union legislation.
What about the IVDR?
The European Commission’s Notified Body database NANDO section for the In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) does have NB 2934 listed. But it is likely that an organization that becomes designated six months before the IVDD is replaced by the IVDR has plans to become designated for the IVDR, as well. Although nothing is formally confirmed, this IVDD designation may be good news for the European IVD community.
Considerations for the IVDR certification strategy
When it comes to CE Mark certification under the new Regulations, there is a very simple truth: No manufacturer can be certain about their certification until they are actually certified. The timelines for IVDR certification have been extended and manufacturers can rely on IVDD Declarations of Conformity for a longer period of time. Still, that IVD manufacturers must work hard to get ready for IVDR certification, because:
- It is only possible to rely on an IVDD Declaration of Conformity if there is no significant change tothe device or the quality management system of the manufacturer.
- It is expected that Notified Bodies will be extremely busy as the deadlines for certification approach.
- Emergo by UL has heard feedback from Notified Bodies designated for the IVDR that they currently have enough capacity to process these certifications. This suggests that industry is not fully using the available capacity at Notified Bodies.
- With the IVDR presented in 2017 and an additional extra timeline, it is expected that Competent Authorities will be quite strict on these new deadlines; they may take the position that manufacturers have had enough time to be certified (see previous point).
Emergo by UL therefore recommends that IVD manufacturers make sure they know which Notified Bodies to approach if they want to start with their IVDR certification. In the meantime, manufacturers should have their quality management system, performance evaluation and the rest of their technical documentation fully ready for Notified Body assessment, so they can act swiftly if necessary.
As mentioned above: No manufacturer can be certain about their certification until they are actually certified.
Additional European IVD regulatory resources:
- EU In-Vitro Diagnostic Medical Devices Regulation (IVDR) gap assessment and CE Mark transition support for IVD companies
- EU IVDR training
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies
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