What to do if your product is reported

This page contains information for manufacturers and suppliers. If we have contacted you about an incident involving your product, here’s what you need to know.

Who we are

The Incident Reporting and Investigation Centre (IRIC) provides specialist safety and risk management support under a remit from Scottish Government – DL(2024)32. Our purpose is to improve the safety of equipment and facilities in Scotland's health and social care services.

We work in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA). We also work with our counterparts in other devolved administrations.

IRIC is part of NHS Scotland Assure (NHSSA) which is a division of NHS National Services Scotland.

What we do

We investigate incidents involving medical devices, IVDs, estates, facilities, social care equipment and PPE. We do this based on incident reports sent to us by Scotland’s health boards and local authorities.

We use the data from incident reports to identify trends which we investigate and resolve to prevent the same thing happening again.

In the interest of safety, we may share information with colleagues in National Procurement, the Scottish Health Technologies Group and other specialist advisory groups. We may also share information with our counterparts in England, Wales and Northern Ireland.

How to work with us

Whenever possible, we work with manufacturers and suppliers to investigate and resolve incidents.

We will contact you if we are investigating an incident report about your equipment.

Your co-operation helps us protect the safety of patients, service users and staff.

What happens next

Once we conclude an investigation, we provide feedback on the outcome to the person who submitted the report.

This may include information you provide about the safety and performance of a device. We always respect the confidentiality of commercially sensitive information.

We share information with MHRA on all incidents involving medical devices and IVDs in Scotland and we update them on the outcome of investigations.

Reporting incidents to MHRA

It is the manufacturer’s responsibility to assess whether incidents reported to them by IRIC should be reported to MHRA by them under the terms of the Medical Devices Regulations. This is also called a vigilance report.

If you send a vigilance report to MHRA based on an incident reported to you by us, please quote our reference number. This helps MHRA avoid having two files on the same incident. You should continue working with us independently to any enquiries MHRA may raise with you.

Submitting a report to IRIC is not equivalent to, or a substitute for, submitting a vigilance report to MHRA.