Nov 4, 2020

In-vitro diagnostic (IVD) device manufacturers have one less Notified Body (NB) designated to the European In-Vitro Diagnostic Medical Devices Directive (IVDD) to choose from for obtaining CE Marking.

The IVDD designation of the Turkish NB Turkish Standards Institution (TSE) has been suspended from October 15th, 2020. The TSE website no longer lists this service. No reason for the suspension has been provided by the European Commission or TSE, but it is likely this implies that TSE no longer wants to be designated under the IVDD for CE Mark certification services.

At this moment 21 NBs are still designated for the IVDD, and four have been designated for the upcoming In-vitro Diagnostic Medical Devices Regulation (IVDR). However, one such NB is based in the UK and may lose its designation soon due to Brexit. For IVD manufacturers, the options for obtaining CE Mark certification for the IVDR before the Regulation’s Date of Application, May 26th, 2022, are still very limited. On top of that the coronavirus pandemic is limiting the ability of NBs to perform on-site audits.

There are currently no signs the European authorities want to delay the implementation of the IVDR. This means Europe is currently heading into a situation where significant numbers of IVDs may not be certified.

Additional European IVDR and IVDD resources from Emergo by UL:

Author

  • Ronald Boumans

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