Notified Body Designation Process

2017/11/29

The Notified Body Operations Group (NBOG) published their Best Practice Guide on Designation and notification of conformity assessment bodies (NBOG BPG 2017-1 rev.1) together with four (4) new forms (NBOG F 2017-1 rev.2, NBOG F 2017-2 rev.2, NBOG F 2017-3 and NBOG F 2017-4)

Notified bodies can submit their application dossier to their designating authority as of November 26th 2017. The designating authority then has 30 days to review application and submit this to Commission (if the application is deemed complete). Then the designating authority has an unspecified amount of time to develop their assessment report (estimated to take 8 weeks), submit this to Commission who immediately submits it to the Medical Device Coordination Group (MDCG). Commission & MDCG assign the Joint Assessment Team (JAT) within 14 days.
A detailed timeline can be found in the Best Practice Guide “NBOG BPG 2017-1 rev.1” Annex 1.

The JATs, that will thus be assessing the conformity assessment body applying for designation under the IVDR and/or MDR, are to be composed of three experts, one from the Commission and two from Member States other than the Member State in which the applicant is located. The authority responsible for notified bodies together with the JAT shall plan and conduct an on-site assessment of the applicant conformity assessment body. The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.

DG GROW and DG SANTE jointly prepared an Information Note, seeking to address some of the concerns raised with regards to the Notified Body (NB) designation process, including the JAT assignment and planning of on-site audits.

The order in which the JATs are assigned and the subsequent planning of the on-site assessment audits (at the site of the conformity assessment body applying for designation) depends on:

  • Date and exact time of receipt of the preliminary assessment report from the designating authority;
  • availability of the JAT experts, the designating authority and the applicant conformity assessment body (keep in mind the composition of the JAT);
  • quality of the conformity assessment body’s application dossier or of the designating authority’s preliminary assessment report.

The first on-site assessments are likely to start around September 10th 2018. According to the Best Practice Guide from NBOG, the first designations are estimated to be official at the end of July 2019.

The request from conformity assessment bodies to combine designation procedures were all discarded with the following explanations:

  • Combined assessments under the Medical Devices Directives and the new Regulations are impossible as the respective designations have a different legal basis and, accordingly, are subject to different legal requirements.
  • Joint assessments under the MDR and IVDR will require different qualifications from the JAT experts. Therefore, where a conformity assessment body applies for designation under both Regulations, two different on-site assessments will be scheduled.

There is still a long road ahead before the first Notified Bodies will become designated under the MDR and IVDR contributing to the challenges industry faces in the transition to the new Regulations.

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