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:
- A new Manufacturer’s Incident Report (MIR) form and a new template for FSN. The MIR will become mandatory in January 2020;
- An updated definition of Field Safety Corrective Action (FSCA). The definition now provides that a safety related device inspection by the user is also to be considered an FSCA. The definition now clarifies the defining criteria to determine whether an action taken is an FSCA. Those criteria are both the nature of the action taken and the reason giving rise to the need for the action.
- An updated definition of Field Safety Notice (FSN). The definition now clarifies the target audience of an FSN. FSNs are primarily aimed at the customers and/or users of the medical devices;
- Additional guidance for the implementation of FSCA by legal manufacturers;
- Guidance for National Competent Authorities to determine when there is a need for a single coordinating National Competent Authority and a Vigilance Task Force;
- Guidance on when national competent authorities need to disseminate information through the National Competent Authority Report (NCAR) to other Competent Authorities and the European Commission.