How to Report a Medical Device Incident in Ireland
Published 5 March 2026 · 6 min read
Under the MDR (Article 87), healthcare institutions in the EU have an obligation to report serious incidents involving medical devices. In Ireland, those reports go to the HPRA (Health Products Regulatory Authority). This guide walks you through the process.
What Counts as a “Serious Incident”?
Under MDR Article 2(65), a serious incident is any malfunction or deterioration of a device that directly or indirectly leads to, might have led to, or might lead to:
- Death of a patient, user, or other person
- Serious deterioration in health
- Serious public health threat
Key point: “Might have led to” means you should report near-misses too. If a device malfunctioned but no one was hurt this time, it’s still reportable if harm could have occurred.
Step-by-Step: How to Report
Step 1: Secure the device
Remove the device from use but do not discard or alter it. Preserve it in its current state. Note the batch/lot number, serial number, and UDI if available.
Step 2: Report internally
Follow your hospital’s incident management procedure (e.g., NIMS/STARSweb in HSE settings). Notify your line manager and your clinical engineering department or medical device liaison officer.
Step 3: Report to the HPRA
Submit a report via the HPRA’s online Medical Device Incident Report Form at hpra.ie. You can also email [email protected].
Step 4: Cooperate with investigation
The HPRA or the manufacturer may follow up. Keep the device available, retain any packaging or documentation, and be prepared to provide clinical context.
Reporting Timelines
- Serious public health threat: Report immediately, no later than 2 days
- Death or unanticipated serious deterioration: Report within 10 days
- Other serious incidents: Report within 15 days
These timelines apply to manufacturers under MDR Article 87, but healthcare institutions should report as soon as practically possible.
Common Mistakes
- Discarding the device before it can be examined.
- Assuming the manufacturer will report it — healthcare facilities have their own obligation.
- Only reporting if harm occurred — near-misses are reportable too.
- Delaying the report while waiting for a full investigation — initial reports can be updated later.
Practice This
Our training includes realistic incident reporting scenarios that walk you through the decision-making process.