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:

Mandate, objectives and rules of procedure for the EMA/CAT and Medical Devices’ Notified Body (EMA/CATNB) Collaboration Group (CG)

Reference Number: EMA/327938/2010

English (EN) (167.18 KB - PDF)

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Work program 2011 of the EMA/CAT and Medical Devices’ Notified Body (EMA/CAT-NG) Collaboration Group

Reference Number: EMA/328081/2010

English (EN) (56.79 KB - PDF)

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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.

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