[co-author: Grégoire Paquet]
The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the requirement for a European Medical Devices Vigilance System. The Medical Devices Vigilance System is the European system for the notification and evaluation of incidents and Field Safety Corrective Actions (FSCA) involving medical devices.
The Medical Devices Vigilance System aims at reducing the likelihood of occurrence and reoccurrence of an incident elsewhere. This is done by the implementation of FSCA across the EU Member States where the device is in use, in contrast to actions taken on an individual EU Member State basis.
The European Commission has published new Additional Guidance (the ‘Guidance’) complementing the 2013 MEDDEV 2.12-1 rev 8 guidelines on the Medical Devices Vigilance System. The Guidance clarifies certain sections of the initial guidelines and introduces new notions.
The Additional Guidance provides for: