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

dgrainger

Trusted Information Resource
#1
Just published: DocsRoom - European Commission

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

Trusted Information Resource
#2
Salient point to extract and mention to people scrolling past. An official answer has been given:
"The updated version of the MIR Form V 7.2 will become mandatory from January 2020."

Other audit bait is that (the common sense of) new introduction to markets should take into account the review and possible re-issue of prior Field Safety Notices to that new market is now explicitly noted, and auditors may expect to see that in your procedures.
 
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