Post-Market Surveillance & Vigilance
Post-market surveillance (PMS) and vigilance are critical regulatory obligations under both MDR (EU) 2017/745 and IVDR (EU) 2017/746. They ensure that medical devices remain safe and perform as intended throughout their entire lifecycle — not just at the point of market entry.
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What Is Post-Market Surveillance?
Post-market surveillance is a proactive and systematic process through which manufacturers collect, record, and analyse relevant data on the quality, performance, and safety of a medical device throughout its entire lifetime. This is defined in MDR Article 83 and IVDR Article 78.
PMS (Post-Market Surveillance)
Proactive — the manufacturer actively gathers data about their device from various sources including user feedback, literature, registries, and complaints. Governed by MDR Articles 83–85 and MDR Annex III.
Vigilance
Reactive — triggered when a serious incident occurs or when a field safety corrective action is needed. Governed by MDR Articles 87–92 and IVDR Articles 82–87.
Key Difference from the Old Directives
Under the previous Medical Device Directive (MDD 93/42/EEC) and IVDD (98/79/EC), PMS was less structured. The MDR and IVDR now require a documented PMS plan for every device, with specific outputs (PMS reports or PSURs) depending on the device class. This represents a fundamental shift from a primarily reactive system to a proactive lifecycle approach.
The Vigilance System
Vigilance is the system through which serious incidents involving medical devices are reported, investigated, and resolved. Under MDR Article 87, manufacturers must report serious incidents to the competent authority of the Member State where the incident occurred.
What is a Serious Incident? (MDR Article 2(65))
Any incident that directly or indirectly led to, might have led to, or might lead to:
- •Death of a patient, user, or other person
- •Serious deterioration in the state of health of a patient, user, or other person
- •Serious public health threat
Reporting Timelines (MDR Article 87(2)–(5))
DAYS
Serious public health threat
Imminent risk requiring urgent field safety corrective action
DAYS
Death or unanticipated serious deterioration
Incidents resulting in death or unexpected serious health deterioration
DAYS
All other serious incidents
Standard reporting timeline for serious incidents that don't fall under the 2 or 10 day categories
Note: These timelines apply to the manufacturer. Healthcare facilities should report internally as quickly as possible so the manufacturer can meet these deadlines.
Your Role in Vigilance (Hospital Setting)
As a healthcare professional, you are often the first to observe a device incident. Under MDR Article 87(10), healthcare institutions shall support manufacturers and competent authorities in vigilance activities. Many Member States also have national incident reporting systems where healthcare professionals can report directly.
When to Report an Incident
Step-by-Step: Reporting an Incident in Your Hospital
- 1Ensure patient safety — address the immediate clinical situation first
- 2Isolate the device — do not discard, reset, or return it to service. Preserve all packaging and accessories
- 3Document everything — date, time, device details (UDI/serial number), what happened, patient outcome
- 4Report internally — notify your department head, risk management team, and biomedical engineering
- 5Notify the manufacturer — your hospital's incident coordinator should contact the manufacturer or their authorised representative
- 6Report to competent authority — in Ireland, report to the HPRA. Other EU states have their own competent authorities
Trend Reporting (MDR Article 88 / IVDR Article 83)
Beyond individual incident reports, the regulations require monitoring for trends. If there is a statistically significant increase in the frequency or severity of incidents or expected undesirable side-effects that could impact the benefit-risk assessment, this must be reported to competent authorities.
Examples of Reportable Trends
- • Increasing complaint rates for a specific device model over time
- • Higher-than-expected failure rates during a particular procedure type
- • Clustering of similar adverse events across different healthcare facilities
- • Emerging use-error patterns not identified during pre-market evaluation
- • Rise in infections or complications following device implantation
Hospital Role: Even if individual incidents seem minor, document them consistently. Your internal data can reveal trends that aren't visible at the manufacturer level. Regular communication between clinical departments and your biomedical engineering or risk management team is essential for detecting patterns early.
Key Takeaways
Remember as a Healthcare Professional
- Report any device incident immediately — even if the patient wasn't harmed
- Preserve the device and all packaging after an incident
- Record UDI/serial numbers for traceability
- Act promptly on Field Safety Notices when you receive them
- Know your hospital's incident reporting chain and competent authority
Your Hospital's PMS Role
- Maintain accurate device inventories with UDI information
- Cooperate with manufacturer PMS and PMCF activities
- Track internal trends in device complaints and failures
- Ensure implantable device data is recorded for patient traceability
- Include PMS awareness in your staff training programmes
Irish Context — Vigilance & the HPRA
In Ireland, all serious incidents must be reported to the HPRA. Manufacturers report directly; hospitals should also notify the HPRA if they become aware of a serious incident.
The HPRA publishes Field Safety Notices (FSNs) from manufacturers and coordinates with EU authorities via the EUDAMED vigilance module.
HSE hospitals should have a process to receive and action HPRA safety notices — typically managed through the clinical engineering or risk management department.
Trend reporting: if you notice recurring near-misses or minor incidents with the same device, report this to the HPRA even if individual incidents do not meet the serious incident threshold.
Useful HPRA Links:
This is educational content only and is not an accredited or externally verified course. Always refer to official HPRA publications and your facility's own policies.