Reporting adverse incidents involving medical devices

The information from adverse incident reports can help identify faults with medical devices and may prevent similar incidents happening again. If you have experienced a problem with a medical device, please send us the details using one of our online forms. We will assess and, where appropriate, investigate all incident reports that we receive.

Use our online reporting systems

Full information and guidance on reporting adverse incidents is published in the first MHRA Device Bulletin of each year:

Reporting medical device related incidents and disseminating medical device alerts.

General reporting enquiries should be directed to the Adverse Incident Centre: aic@mhra.gsi.gov.uk or 020 7084 3080.

Alternative reporting methods
You may also send reports to the Adverse Incident Centre by fax, email or post. All our report forms may be downloaded as Word or pdf files.

Keeping in touch with you
Online reporters will receive an automatic acknowledgement with a unique MHRA adverse incident reference number. The reference number will appear in the following format: 2009/002/014/401/001. If you do not automatically receive an MHRA reference number, please contact the Adverse Incident Centre by other means (ie email, telephone or fax).

Every report we receive is acknowledged and given a unique MHRA reference number. We will then keep in touch with you and let you know the outcome of our risk assessment and, where appropriate, the conclusion of the investigation undertaken by our medical device specialists.

Out of hours
Outside of normal office hours, the AIC hotline will connect to an answering machine. This machine carries a message that includes an out-of-hours telephone number. In cases of urgency senior MHRA officials can be contacted quickly.

Report forms for medical device manufacturers
We recommend that manufacturers or their authorised representatives use MORE for reporting incidents and field safety corrective actions to the MHRA. If not using MORE, we recommend that manufacturers use the standard incident report form and field safety notices (FSN) form. If using MORE for a field safety notice, the FSN form can be attached to the online MORE form.

General information and guidance documents
All adverse incidents involving medical devices should be reported to the MHRA as soon as possible, even if user error (rather than a device problem) is suspected. While the MHRA would like your initial report to contain as much relevant detail as is available, submission should not be unnecessarily delayed. However, it is important that names and contact details of persons who may be contacted for further information should be included on the form. Serious incidents must be reported to MHRA by the fastest means available.

Telephone reports, taken only for incidents involving death, serious injury or serious public health concern, should be followed up as soon as possible by a written report.

For up-to-date guidance on what to do with devices that have been involved in incidents please refer to the latest Device Bulletin on reporting medical device-related incidents and disseminating medical device alerts. Do not send devices to MHRA unless specifically requested to do so. It is illegal to send contaminated items through the post.

Incidents occuring in Scotland, Northern Ireland and Wales
The latest guidance on reporting incidents occuring in Scotland, Northern Ireland and Wales is published in:

Northern Ireland : MDEA(NI)2009/01
Scotland : SAN(SC)07/01
Wales : NDA/2004/054.