Applications to be designated as NB under MDR/IVDR open from 26 November

6 months after entering into force of the new legislation, the European Commission  issued a notice informing of the possibility to submit the application to be designated as a notified body (NB) under the MDR/IVDR as from 26 November 2017. The procedure is open both to NB already designated under the Medical Devices Directives or any new conformity assessment body.

The notice particularly focuses on Article 39 of MDR and Article 35 of IVDR (Assessment of the application).

The notice recalls the composition of Joint assessment team (JAT) of the applications submitted, which shall be composed of 3 nominated experts: one from the Commission and two from Member States other than the country where the applicant  is established.

The notice particularly addresses the procedural aspects and criteria on the order of the assessment of the application, which shall look as follows:

1. Application dossier + Preliminary assessment report from the designating authority to be sent to the Commission functional mailbox.

2. Appointment of the JAT.

3. On-site joint assessment (which might be delayed due to missing documents in both Application dossier and/or Preliminary assessment report!).

The Information notice equally addresses the difficulties with regard to the potential unavailability of designated JAT experts.

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