What to do if your product is reported
Published on 14 January 2021
This page contains information for manufacturers and suppliers. If we have received an incident report about your equipment, here’s what you need to know.
Who we are
The Incident Reporting and Investigation Centre (IRIC) is Scotland's specialist national safety and risk management unit. 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 Health Facilities Scotland (HFS). HFS is a division of NHS National Services Scotland.
What we do
We investigate incidents involving medical devices, social care equipment, estates and facilities. We do this via a reporting system used by health boards and local authorities.
We use the data from incident reports to identify trends so we can 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 keep any commercially sensitive information confidential.
We notify MHRA of all incidents involving medical devices and update them on the outcome of investigations.
Reporting incidents to MHRA
It is the manufacturer’s responsibility to assess whether incidents should be reported to MHRA under the terms of the Medical Devices Regulations. This is also called a vigilance report.
If you send a vigilance report to MHRA, please quote our reference number. This helps MHRA avoid having two files on the same incident.
Submitting a report to IRIC is not the same as (or a substitute for) submitting a vigilance report.