On July 10, 2019, the European Commission issued the “ Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 ”, complementary to MEDDEV 2.12-1 rev. 8Guidelines on a Medical Devices Vigilance System” issued in 2013. This Document provides further indications regarding the Medical Devices Vigilance System currently in force pursuant to the European Directives.

EUROPEAN UNION: New guidance on the Medical Devices Vigilance System publishedU

The aforementioned guidance clarifies a few existing definitions for FSCA (Field Safety Corrective Action) and FSN (Field Safety Notice) and introduces several new documents, including:

  • a revised version of the Manufacturer’s Incident Report (MIR) with references to UDI and SRN, to be included as early as January 2020 in the databases of device manufacturers in preparation for the future European regulatory framework;
  • a new Field Safety Notice template;
  • vigilance guidelines for specific devices.

Furthermore, this guidance aims to clarify the methods of dissemination/publication of the National Competent Authority Report within the European community (EU NCAR) and internationally (IMDRF NCAR).

The most up-to-date version of all the aforementioned modules and documents, in support of the Medical Devices Vigilance System, can now be found on the European Commission’s website under section 2.12 Post-Market Surveillance.