Journey Step 5 of 5

Check 5: Are you ready for vigilance reporting?

Step 5 of 5

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

Step-by-step guide to reporting serious medical device incidents to MHRA via the MORE portal. Covers incident identification, timeline classification (2, 10, or 15 calendar days), MIR form submission, follow-up investigation, CAPA, and Field Safety Corrective Actions.

Read the guide →