The EU Commission has recently released a graphic that numerically reflects how many Notified Bodies are currently undergoing the different enabling steps to eventually be notified to NANDO as IVDR and/or MDR Notified bodies.
Source of the image: European Commission., Overview of NBs at each stage of the process. Update – 21 October 2020
Find the highlights below:
How many applications there are so far?
- 48 Notified Bodies have applied to be designated under the MDR. 44 out of these are current bodies under the Directive and 4 are new applicants
- There are 15 applicants for designation under the IVDR. 1 of them is a new applicant whereas the rest are current bodies under the IVDD.
Preliminary Assessment Reports
- 42 MDR and 12 IVDR preliminary assessment reports have been issued already. This constituting the 86% of the total sum of applications.
Final Stage
Considering the numbers altogether we notice that out of 63 applications:
- 21 Notified Bodies have been officially designated and published in NANDO (17 MDR + 4 IVDR)
- 33 are in the DA final report stage, 10 of those being pending and 23 reports submitted.
- 23 JAT final opinions issued and MDCG Recommendations likewise
- Overall, 34 JAT CAPA plan reviews.
As documented, the process of the NB designation is yet going on, trust MDlaw to keep you posted!
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