Milestone 5 of 5 Medical device compliance quick check

Check 5: Are you ready for vigilance reporting?

Verify you can meet the statutory reporting timelines if an incident occurs:

  • Are you registered for the MHRA MORE portal?
  • Do you have a process to identify reportable incidents within hours?
  • Can you submit a preliminary MIR within 2 calendar days if needed?
  • Do you have FSCA and Field Safety Notice templates ready?

Report a medical device safety incident to MHRA

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