Healthcare & Social Care Product compliance and marking

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.

UK-wide
Guide summary

You must report serious medical device incidents to MHRA within 2 to 15 calendar days. Use the MORE portal and include details like the device ID and what happened. If devices already on the market are affected, you may need to recall them.

  • Report incidents causing death within 10 days
  • Report public health threats within 2 days
  • All other serious incidents within 15 days
  • Submit a Manufacturer Incident Report (MIR) via MORE portal
  • Include device ID, incident details and patient outcome
  • Investigate root cause and submit follow-up reports
  • Start a Field Safety Corrective Action if needed
  • Failure to report can lead to fines or prosecution
  • Penalties can be unlimited fines or prison time
  • MHRA may escalate from warnings to criminal charges
On this page
UK-wide

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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