NB-MED Performed a survey on IVDR Readiness of the Notified Bodies.

The NB-MED recently published the results of a survey performed between 2018 and January 2019 on the applications of Notified Bodies to be designated under the IVDR.

Among the 37 Notified Bodies, currently only 19 are designated for IVDD; most of them have up to 50 Certificates each. The survey revealed that out of the 19 Notified Bodies for IVDD, 2 will not apply for IVDR and 1 of them has not yet decided whether they would apply or not. Moreover, 17 Notified Bodies not designated for IVDD, will also not apply for IVDR (although one is still deciding).

This means that only 17 Notified Bodies will or already have applied for the IVDR. Three of them will submit their application in 2019 or later; while the other 14 have already applied or went through the Joint Assessment between September and December 2018.

More importantly, the majority of NBs applied for the same or a broader scope. This implies that all the codes under IVDR are at least covered by 9 Notified Bodies (only the codes IVR 0104, IVR0105, IVR 0202 are covered by just 9 NBs).

If you wish to know more about the changes brought by the new IVDRvisit MDlaw.eu, or if you would need our assistance with Obelis Notified Body Selection Service, please do not hesitate to contact us. Obelis Experts, having more than 30 years of experience with EU Regulations, will gladly answer your questions.

Clàudia Miralles