Guide
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.
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
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