Medical device vigilance reporting timelines
Statutory timelines for reporting serious medical device incidents to MHRA, effective 16 June 2025.
- Effective date
- 16 June 2025
- Serious public health threat
- 2 calendar days from when manufacturer becomes aware
- Death or unanticipated serious deterioration in health
- 10 calendar days from when manufacturer becomes aware
- All other reportable serious incidents (including anticipated serious deterioration)
- 15 calendar days from when manufacturer becomes aware
- Previous reporting deadline (replaced)
- 30 calendar days
- Reporting portal
- MHRA MORE (Medical Online Reporting Environment)
- Who must report
- UK Responsible Person, manufacturer, or authorised representative
- Reportable serious incident definition
- Death of a patient, user, or other person; serious deterioration in the state of health; or a serious public health threat
- Trend reporting
- Required when statistical patterns of incidents are identified
- Field Safety Corrective Action (FSCA)
- Required when investigation identifies risk to devices already on the market (e.g. recall, modification, additional warnings)
- Geographic scope
- Great Britain (England, Scotland, Wales)