May 2, 2022

If you are an IVD device manufacturer doing business in Europe, you will be pleased to know that another Notified Body (NB) has been designated to certify these products under the upcoming European In-vitro Diagnostic Medical Devices Regulation (IVDR). The European Commission announced that 3EC International a.s. is now the seventh Notified Body added to the NANDO database and authorized to issue CE Mark certificates under the IVDR. This is good news in light of the fact that the IVDR is set to take effect later this month.

Why is having another NB authorized to certify IVD products under IVDR a positive step?

There has been some concern in the IVD industry that there might not be enough NB regulators authorized to certify IVD devices once the IVDR takes effect on May 26, 2022.

As we have previously reported, a position paper issued by Team-NB, the European association of Notified Bodies dealing with medical devices, raised concerns about the viability of the IVDR implementation date, given that the percentage of IVD devices anticipated to require CE Marking from NBs will increase from less than 10% currently to more than 80% under the IVDR. Thus, this latest addition of another Notified Body to the NANDO database should come as welcome news. Some may see it as a positive sign that more NBs could soon be added to the list in order to fully support manufacturers with IVDR compliance.

Emergo by UL will continue to post updates as they become available.

Learn more about European IVD regulatory requirements at Emergo by UL:

  • European CE Mark consulting for IVD device manufacturers
  • European Authorized Representative in-country representation
  • Usability engineering (UE) support for the EU IVDR transition
  • Whitepaper: Understanding Europe’s IVDR 2017/746
  • Webinar: Human factors engineering for IVD products under IVDR

Author

  • Kathryn Burke's picture
    Kathryn Burke

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