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New EU Vigilance Report Forms mandatory from 1 January 2020

  • Posted by: inetika
  • Category: GLOBAL NEWS

Manufacturers should remember that the EU has introduced new forms for vigilance and field safety corrective action (FSCA) reporting, reflecting certain requirements from the Medical Devices Regulation (MDR, 2017/745), which became mandatory from 1 January 2020.

The new MIR Form can be downloaded from here, and Help Text, in Excel format, is available from here.