New MEDDEV 2.12-1/rev7 on Vigilance Systems published
The new MEDDEV 2.12-1/rev7 Guidance document released in March 2012 has updated the requirements related to the European system for the notification and evaluation of incidents and field safety corrective actions (FSCA) involving medical devices. The revised guidance will be applicable as of June 15th 2012.
This 7th revision of these guidelines has:
- Promoted harmonization with the Global Harmonization Task Force (GHTF) provisions of regulatory guidance documents on vigilance and post market surveillance in the European Market;
- Addressed the introduction of EUDAMED, the European Database of Medical Devices;
- Amended the document in light of experience with previous clauses.
The main aim of the Medical Device Vigilance System is to increase the protection and safety of patients and reduce the possibility of re-occurrence of incidents. In this respect, a need for such a system to be able to evaluate the reported incidents, disseminate the information and prevent their repetition is indeed vital.
These guidelines are intended to facilitate the uniform application and implementation of the
Medical Device Vigilance System requirements contained within:
- The Medical Devices Directive (MDD), 93/42/EEC;
- The Active Implantable Medical Devices Directive (AIMD), 90/385/EEC;
- The In Vitro Diagnostic Medical Devices Directive (IVDD), 98/79/EC.
The Guidelines document is comprised of 9 sections, out of which 5 of them stress the importance of the roles, several actors play within the process:
- Manufacture’s role: or the role of its designated European Authorized Representative;
- Responsibilities of the National Competent Authority;
- The role of the Notified Bodies;
- The role of the Commission;
- User’s role within the Vigilance system.