Reporting medical device & IVD safety issues
This page is for hospitals and healthcare professionals.
It describes what safety reporting is, how to report and why it is important.
What is medical device and IVD safety reporting?
Sometimes, a device can have an issue or problem which can lead to an incident or harm to a patient or the public.
Safety reporting refers to the submission of information about such an incident, by a patient, carer or healthcare professional, to the HPRA.
To report a safety issue, you can use our online report form.
When to report a medical device or IVD safety issue to the HPRA?
Hospitals and healthcare professionals (HCPs) should report serious incidents to us.
A serious incident is any incident that directly or indirectly led, might have led or might lead to any of the following:
- The death of a patient, user or other person
- The temporary or permanent serious deterioration of the patient’s, user’s or other person’s state of health
- A serious public health threat
If you are in doubt if an issue falls within these criteria, we still encourage you to report it to us.
Why is medical device and IVD safety reporting important?
Reporting device safety issues is critically important.
Safety reporting:
- Protects patients by helping to identify and address device-related risks before more patients are affected.
- Can improve devices by providing real-world information about safety, quality and performance.
- Triggers corrective action by starting the process for manufacturers to investigate and rectify identified issues.
- Enables authorities and manufacturers to detect trends, issue safety alerts and take action where needed.
What does the HPRA do when we receive a report?
For more information on how we process safety reports, please see our monitoring device safety webpage.
How can I report a safety issue to the HPRA?
Device safety issues can be reported to us via our online report form.
You can also report a safety issue to us by:
- Emailing a completed incident report form to us at devicesafety@hpra.ie. This form is linked below.
- Posting a completed incident report form to us at Medical Devices Department, HPRA, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77.
- Phoning us at +353 (0)1 676 4971.