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