There is a choice of format to download, fill in and return via email (aic@mhra.gsi.gov.uk), fax (020 3118 9814) or post (Adverse Incident Centre, MHRA, Floor 4, 151 Buckingham Palace Road, London SW1W 9SZ).
| Form | Choose format | ||
|---|---|---|---|
| General reporting form (for healthcare profesionals) | MS Word  (279Kb) |
PDF (26Kb) |
RTF (80Kb) |
| General reporting form (for members of the public) | MS Word (82Kb) |
PDF (95Kb) |
RTF (33Kb) |
| Breast implants (for surgeons) | MS Word (106Kb) |
PDF (129Kb) |
RTF (77Kb) |
| Breast mplants (for members of the public) | MS Word (98Kb) |
PDF (23Kb) |
RTF (83Kb) |
| Cochlear implants | MS Word (96Kb) |
PDF (31Kb) |
RTF (59Kb) |
| Hip or knee | MS Word (126Kb) |
PDF (197Kb) |
RTF (126Kb) |
| Implantable pacemakers/defibrillators | MS Word (130Kb) |
PDF (30Kb) |
RTF (118Kb) |
| In vitro diagnostic (IVD) devices | MS Word (91Kb) |
PDF (24Kb) |
RTF (61Kb) |
| Limb prosthesis | MS Word (92Kb) |
PDF (122Kb) |
RTF (86Kb) |
| Orthotic devices | MS Word (278Kb) |
PDF (146Kb) |
RTF (75Kb) |
| Wheeled mobility and associated equipment | MS Word (100Kb) |
PDF (117Kb) |
RTF (80Kb) |
Reporting forms for manufacturers
We recommend that manufacturers or their authorised representatives use MORE, our Manufacturer Online Reporting Environment, for reporting adverse incidents and Field Safety Corrective Actions to the MHRA.
We also recommend that manufacturers use the suggested Field Safety Notice form below to communicate this information to the MHRA and UK users.
MORE can now be used to submit FSNs.
Manufacturers are also encouraged to use the Periodic Summary Reports (PSR) and Trend Report forms, included in the list below, which are in the process of being agreed within Europe.
- Incident report form (553Kb)
- Field Safety Corrective Action (MS Word (121Kb), RTF (241Kb), PDF (21Kb))
- Periodic Summary Reports (163Kb) (PSR)
- Trend report (142Kb)
Email to: aic@mhra.gsi.gov.uk or Fax: 020 3118 9814
Post: Adverse Incident Centre, MHRA, Floor 4, 151 Buckingham Palace Road, London SW1W 9SZ
Support documents for manufacturers
- Detailed guidance on preparing a Field Safety Notice (MS Word (33Kb), RTF (31Kb))
- Flyer (266Kb) explaining what an FSN and an FSCA are, which you can include with your FSN, to encourage healthcare professionals to respond.
