Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8.pdf

Someone may say it comes late in the game since MDR should NOW be in implemented but it is helpful for the new MIR form and for a better understanding of the collaboration among authorities.

The document:

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