Report AI Medical Device Incidents Simply
Help make AI in healthcare safer by reporting problems to the MHRA. This tool guides you through creating a Yellow Card report in about 5 minutes.
Start Your ReportWhat Can You Report?
Any issue with AI or software used in healthcare settings, including:
- AI that gave incorrect medical advice or diagnosis
- Transcription or scribe software that made errors in clinical notes
- Diagnostic AI that gave wrong or misleading results
- Apps that crashed or malfunctioned during clinical use
- AI recommendations that led to wrong treatment decisions
- Dosage calculators that produced incorrect values
- Any software issue that caused (or could have caused) patient harm
Who Can Report?
Anyone can submit a Yellow Card report. You don't need to be a healthcare professional.
- Healthcare professionals — GPs, nurses, pharmacists, specialists
- Patients and carers — if you've experienced an issue with an AI health app
- Clinical Safety Officers — reporting on behalf of your organisation
- Manufacturers — reporting issues with your own products
How It Works
- Answer simple questions about the incident (about 5 minutes)
- Review your report summary
- Copy the formatted report to your clipboard
- Submit via email to the MHRA
- You may also use this data to complete the official MHRA Website form. You are required to select the product you wish to report. If you cannot find the software, you may select 'Standalone software and medical device Apps'
Your report helps the MHRA identify patterns, investigate issues, and take action to protect patients.
Your Privacy is Protected
- No server storage — all data stays in your browser until you submit
- Auto-save locally — your progress is saved on your device only
- You control submission — nothing is sent until you copy and submit
- Clear anytime — delete all entered data with one click
Takes approximately 5 minutes to complete