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