How to report — MHRA Submissions portal & Yellow Card
Reports are submitted under Regulations 16–22 of the UK MDR 2002. The MHRA Submissions portal is the primary channel for manufacturer/UKRP reports.
Manufacturer / UKRP: MHRA Submissions portal
Submit adverse incident reports and FSCA notifications at submissions.mhra.gov.uk.
Key information collected:
- Reporter: manufacturer/UKRP name, MHRA registration number, contact person
- Device: name, model, batch/lot, serial number, MHRA/certificate references
- Incident: date of awareness, date of incident, location, description, patient outcome
- Actions: investigation status, root cause (if known), CAPA, whether FSCA initiated
Attach supporting documents — complaint records, failure analysis reports, FSN drafts — via the portal.
Healthcare professionals & patients: Yellow Card
The Yellow Card scheme at yellowcard.mhra.gov.uk allows direct reporting by healthcare professionals, patients, and members of the public. MHRA assesses Yellow Card reports and may follow up with the manufacturer if the event should have been — but was not — reported by the manufacturer.
After submission
- MHRA assigns a case reference number
- MHRA assesses completeness and risk level
- MHRA may request additional information or a progress report timeline
- If action is required, MHRA issues a request or enforcement notice
- MHRA shares relevant safety information with international regulators
- FSCAs are published (redacted as appropriate) on the MHRA website
Vigilance log
Maintain an internal vigilance log recording all complaints received, reportability assessments, report reference numbers, investigation status, and CAPAs. This log is reviewed during UKAB surveillance audits and MHRA inspections.
Official references
| Reference | Description |
|---|---|
| MHRA Submissions portal | submissions.mhra.gov.uk |
| MHRA Yellow Card | yellowcard.mhra.gov.uk |
| MHRA: Adverse incident reporting guidance | Detailed reporting guidance |