Manufacturing & Engineering Product compliance and marking UK-wide

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.

Guide summary

Report any serious incident involving your medical device to MHRA using the MORE online portal. You must follow strict deadlines: 2 calendar days for a serious public health threat, 10 days for death or serious health worsening, and 15 days for all other serious incidents. Not reporting is a criminal offence with penalties including up to 6 months in prison and unlimited fines.

  • Report serious incidents using MHRA MORE portal
  • Serious public health threat: 2 calendar days to report
  • Death or unanticipated health deterioration: 10 calendar days
  • Other serious incidents: 15 calendar days
  • Include device ID, incident details, and patient outcome
  • Submit preliminary report if you lack all information on time
  • Investigate root cause and take corrective actions
  • Issue Field Safety Corrective Action if devices already sold are at risk
  • Failure to report is a criminal offence – up to 6 months in prison
  • MHRA can also issue civil monetary penalties
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If a serious incident occurs involving your medical device on the Great Britain market, you must report it to MHRA within statutory timelines. Failure to report is a criminal offence.

A reportable serious incident is one that directly or indirectly led to, might have led to, or might lead to:

  • death of a patient, user, or other person
  • serious deterioration in the state of health of a patient, user, or other person
  • a serious public health threat

Near-misses where a systematic failure is identified are also reportable.

What to include in your report

When submitting a Manufacturer Incident Report (MIR) via the MORE portal, provide:

  • Device identification (name, model, lot/batch number, serial number, UDI if applicable)
  • Description of the incident and circumstances
  • Patient or user outcome
  • Your assessment of the causal relationship between the device and the incident
  • Corrective actions taken or planned
  • Whether other devices of the same type may be affected

If you do not have all information at the time of initial report, submit a preliminary report within the statutory timeline and follow up as information becomes available.

After reporting

After the initial report, you must:

  • Conduct a root cause investigation
  • Submit follow-up reports to MHRA as new information becomes available
  • Implement corrective and preventive actions (CAPA)
  • Close the investigation with a final report including root cause analysis
  • If devices already on the market are affected, initiate a Field Safety Corrective Action and issue a Field Safety Notice

Reporting guidance and portals