Regulatory Update- MDR 2017/745

August 2019

The EU Commission recently released Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8. 

This document provides additional guidance in relation to the Medical Device Vigilance System that is currently in operation under the Medical Devices Directives. The guidance should complement and be used in conjunction with MEDDEV 2.12-1 rev. 8, 2013. 

Among the changes:

  • Clarification of some of the existing definitions
  • Introduction of a new Manufacturer’s Incident Report and the new template for Field Safety Notice
  • Introduction of device-specific vigilance guidance
  • Provides further detail in relation to the area of the co-ordination of vigilance issues amongst Competent Authorities
  • Clarification of the differences between the EU NCAR exchange and the IMDRF NCAR exchange

The document also highlights that the most recent revision of all the forms which currently support the Medical Device Vigilance System can now be found on the EU commission website replacing the Annexes of the MEDDEV 2.12-1 rev. 8, 2013.