Public Consultations: NB and IVD

1. The European Commission will shortly open public consultations in the context of the new MDR on the Draft implementing regulation on codes for the designation of notified bodies (NB). The NBOG (Notified Body Operations Group) has already issued a Draft list of codes and corresponding types of devices, which can be consulted here.

We would advise manufacturers to ask their NB for which of the codes they will apply under the new MDR, so that they can verify whether their product scope is covered by the future designation scope of the NB.

2. The European Medicines Agency (EMA) has released for public comment a Concept paper – intended to turn into a guideline – providing recommendations on the relation between companion diagnostics and medicinal products.

The Concept paper is relevant for both the notified bodies and the manufacturers of companion diagnostics, which are newly covered by the EU Regulation on in vitro diagnostic medical devices (IVDR). The latter requires their cooperation in the CE marking process for the devices in question. The public consultation will remain open until 15 November 2017.

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