EMA/CAT and Medical Devices Notified Body (EMA/CAT-NB) Collaboration Group

  • Email
  • Help

The European Medicines Agency/Committee for Advanced Therapies and Medical Devices Notified Body (EMA/CAT-NB) Collaboration Group facilitates the implementation of the aspects of Regulation (EC) No. 1394/2007 relating to advanced-therapy medicinal products (ATMPs) when they are combined with medical devices (MD). It is a temporary, ad-hoc, specialised advisory group of the Committee for Advanced Therapies (CAT).

Mandate, rules of procedure and work programme

More information on the EMA/CAT-NB Collaboration Group’s responsibilities and composition is available in these documents:

Composition

The EMA/CAT-NB Collaboration Group represents the regulatory stakeholders for ATMPs and medical devices. The Group includes:

  • up to four representatives from the CAT;
  • two representatives from the Co-ordination of Notified Bodies for Medical Devices;
  • two representatives from the Notified Body Operations Group;
  • two representatives from the European Medicines Agency.

Representatives of the European Commission may participate as observers.

Members

Below (by alphabetical order of surname) are the current members of the EMA/CAT-NB Collaboration Group. The members' declarations of interests are available in the European expert list.

  • Gert Bos
  • Patrick Celis
  • George Andrew Crosbie
  • Rainer Edelhaeuser
  • Rob Higgins
  • Sabine Kloth
  • Manfred Kohler
  • Niall MacAleenan (Chair)
  • Johannes Hendrikus Ovelgonne
  • Marie Helene Pinheiro (Co-Chair)