MEDICAL DEVICES

IN VITRO DIAGNOSTIC MEDICAL DEVICES

Article 49: Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least annually.

The bodies notified under this Regulation shall participate in the work of that group.

The Commission may establish the specific arrangements for the functioning of the coordination group of notified bodies.