Section 6
Post-Market Surveillance
Understanding the ongoing obligations for monitoring device safety and performance after market placement under MDR and IVDR.
Beyond Market Placement: Continuous Vigilance
Post-market surveillance (PMS) under the MDR and IVDR represents a fundamental shift from the reactive approach of the previous directives to a proactive, systematic, and continuous process. The regulations recognise that the true safety profile of a medical device only emerges through widespread clinical use over time, and that manufacturers must actively monitor and respond to this real-world evidence.
For healthcare workers, understanding PMS is essential because you are often the first to observe device-related incidents, performance issues, or unexpected outcomes. Your participation in vigilance reporting, your feedback on device performance, and your involvement in field safety corrective actions directly contribute to the safety of devices used across the EU.
This section covers the key elements of PMS, including the manufacturer's obligations, the vigilance system, periodic safety update reports, and the practical implications for healthcare facilities.
The Post-Market Surveillance System
Article 83 of the MDR requires manufacturers to plan, establish, document, implement, maintain, and update a PMS system for each device. This system must be proportionate to the risk class and appropriate for the type of device. The PMS system is not a standalone activity but is integrated with the quality management system and feeds directly into risk management, clinical evaluation, and regulatory compliance.
PMS System Requirements (MDR Article 83)
- 1Gather, record, and analyse relevant data on quality, performance, and safety throughout the device lifetime
- 2Draw necessary conclusions and determine, implement, and monitor preventive and corrective actions
- 3Update benefit-risk determination and improve risk management based on PMS data
- 4Update design and manufacturing information, instructions for use, and labelling where appropriate
- 5Update clinical evaluation including PMCF based on PMS findings
- 6Identify needs for preventive, corrective, or field safety corrective actions
- 7Contribute to the PMS of other devices where relevant (accessories, similar devices)
The Post-Market Surveillance Plan
Every manufacturer must have a documented PMS plan for each device or device group. This plan is part of the technical documentation and must be reviewed and updated as necessary. The plan outlines how the manufacturer will systematically collect and use post-market data.
PMS Plan Contents (Annex III, Section 1.1)
Data Collection Strategy
Methods for collecting and analysing data from users, distributors, importers, and publicly available information on similar devices.
Complaint Handling
Effective and documented procedures for complaints and non-conformities reported by healthcare professionals, patients, or users.
Trend Analysis
Methods for analysing trends in complaints, incidents, and performance data, including statistical analysis and threshold setting.
Literature Monitoring
Ongoing review of scientific literature, registries, and databases for information relevant to device safety and performance.
PMCF Plan Reference
Integration with the PMCF plan where applicable, or justification if PMCF is deemed not necessary.
Indicators and Thresholds
Defined indicators for triggering review of benefit-risk analysis and statistical methods for analysis.
The Vigilance System
Vigilance is the cornerstone of post-market safety monitoring. The MDR and IVDR establish a comprehensive vigilance system requiring manufacturers to report serious incidents and field safety corrective actions, and enabling competent authorities and the Commission to take coordinated action when necessary.
Key Vigilance Definitions
Serious Incident
Any incident that directly or indirectly led, might have led, 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
Serious Deterioration in Health
Includes: life-threatening illness or injury, permanent impairment of body function or structure, hospitalisation or prolongation, medical or surgical intervention to prevent life-threatening illness or permanent impairment, chronic disease, or foetal distress/death/congenital abnormality.
Field Safety Corrective Action (FSCA)
Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce risk of serious incident, including recall, modification, exchange, destruction, or retrofit of a device already placed on the market.
Field Safety Notice (FSN)
Communication sent by a manufacturer to customers or users about an FSCA, providing information on actions to be taken.
Incident Reporting Timelines
The MDR establishes strict timelines for manufacturers to report serious incidents and FSCAs to competent authorities via EUDAMED. Understanding these timelines helps healthcare workers appreciate the urgency of incident reporting.
| Incident Type | Initial Report | Follow-up |
|---|---|---|
| Serious public health threat | Immediately (max 2 days) | As required by Competent Authority |
| Death or unanticipated serious deterioration | Within 10 days | Final report within timeframe agreed with CA |
| Other serious incidents | Within 15 days | Final report within timeframe agreed with CA |
| FSCA (regardless of incident) | Before implementation | Submit FSN with report |
| Trend of non-serious incidents/expected side effects | Upon detection of trend | Include in trend report |
Trend Reporting (Article 88)
Manufacturers must report any statistically significant increase in the frequency or severity of incidents or expected undesirable side effects. This trend reporting obligation captures patterns that might not be apparent from individual incident reports and ensures that emerging safety signals are detected early.
Healthcare Worker Role in Vigilance
Healthcare professionals play a critical role in the vigilance system. While the legal obligation to report incidents to competent authorities rests with manufacturers, healthcare workers are often the first to identify that an incident has occurred. Many EU Member States have established reporting mechanisms for healthcare professionals.
Recognising Reportable Incidents
Healthcare workers should consider reporting when:
- A device malfunctions during use
- Device labelling or instructions were inadequate leading to incorrect use
- A device fails to perform as intended
- An unexpected adverse event occurs that may be device-related
- A near-miss occurs where harm was only avoided by intervention
- Device quality issues are observed (packaging, sterility, integrity)
Reporting Pathways
To Manufacturer
Primary route for incident reports. Contact details should be in IFU and on labelling. Manufacturers are legally obligated to investigate and report to authorities.
To Competent Authority
Many Member States accept or require direct reports from healthcare professionals. National reporting systems exist (e.g., MHRA Yellow Card UK, BfArM Germany, ANSM France).
Internal Incident System
Report through your facility's incident reporting system. This ensures institutional awareness and may trigger internal investigation and manufacturer notification.
EUDAMED (Future)
When fully operational, EUDAMED will facilitate reporting and provide public access to safety information including FSCAs.
Preserving Evidence
When a device-related incident occurs:
- Quarantine the device if possible (do not discard, return to manufacturer only when requested)
- Document the incident including date, time, personnel involved, and patient outcome
- Photograph the device, packaging, and any visible defects
- Record device identifiers: UDI, lot/batch number, serial number, expiry date
- Note any environmental factors (temperature, humidity, power supply)
- Preserve associated consumables and accessories
Periodic Safety Update Reports
The MDR introduces Periodic Safety Update Reports (PSURs) as a formal requirement for higher-risk devices. PSURs provide a systematic summary of PMS data and conclusions, enabling ongoing regulatory oversight of device safety.
PSUR Requirements by Device Class
| Device Class | Report Type | Frequency | Submission |
|---|---|---|---|
| Class III | PSUR | At least annually | To Notified Body and Competent Authority via EUDAMED |
| Implantables | PSUR | At least annually | To Notified Body and Competent Authority via EUDAMED |
| Class IIa and IIb | PSUR | When necessary (at least every 2 years) | Available upon request; summary in technical documentation |
| Class I | PMS Report | Updated when necessary | Part of technical documentation; available upon request |
PSUR Contents (Article 86)
- •Conclusions of benefit-risk determination
- •Main findings of PMCF evaluation
- •Volume of sales and estimate of users/patients exposed
- •Summary of serious incidents and FSCAs
- •Summary of trend reports submitted
- •Conclusions on need for preventive or corrective actions
Field Safety Corrective Actions
When a manufacturer identifies a safety issue that requires action on devices already in the market, they must implement a Field Safety Corrective Action (FSCA). Healthcare facilities are directly involved in implementing FSCAs and must have systems to ensure affected devices are identified and appropriate action is taken.
Types of FSCA
- •Recall: Return of device to manufacturer or destruction
- •Device modification: Permanent changes to device by manufacturer
- •Exchange: Replacement with corrected device
- •Customer modification: User-implemented fix per manufacturer instruction
- •IFU update: Revised instructions, warnings, or contraindications
- •Software update: Correction via software/firmware patch
Healthcare Facility Response
- 1.Receive and acknowledge Field Safety Notice from manufacturer
- 2.Identify affected devices using UDI/lot/serial numbers
- 3.Quarantine devices if required pending action
- 4.Implement required action per FSN instructions
- 5.Identify affected patients (for implantables) and notify as required
- 6.Return acknowledgement to manufacturer confirming completion
The Importance of Traceability
Effective FSCA implementation depends on the ability to identify affected devices. This is why the MDR emphasises traceability through UDI implementation. Healthcare facilities should maintain records linking UDIs to storage locations, clinical areas, and for implantables, to specific patients. Without this traceability, FSCA implementation is significantly more difficult and may result in continued use of unsafe devices.
Post-Market Surveillance for IVDs
The IVDR establishes similar PMS requirements to the MDR, with adaptations for the unique nature of in vitro diagnostics. Key differences relate to the types of incidents that may occur with IVDs and the concept of Post-Market Performance Follow-up (PMPF).
IVD-Specific PMS Considerations
False Results
False positive or false negative results leading to incorrect diagnosis or treatment decisions. May be caused by interference, cross-reactivity, or inadequate performance in certain sample types.
Lot-to-Lot Variability
Performance variations between different lots/batches of reagents affecting result accuracy or reproducibility.
Specimen Handling Issues
Problems with specimen collection, storage, or transport affecting test performance when used as intended.
Software/Algorithm Performance
For automated analysers and AI-based diagnostics, software issues affecting result calculation or interpretation.
Post-Market Performance Follow-up (PMPF)
PMPF under IVDR is the equivalent of PMCF under MDR. It involves proactive collection of clinical performance data after market placement to confirm ongoing safety and performance. PMPF may include:
- •Monitoring of EQA (External Quality Assessment) performance across laboratories
- •Analysis of discordant results and clinical outcome correlations
- •Performance monitoring across different analysers and laboratory conditions
- •Literature review for performance data on the diagnostic marker
- •User feedback surveys on test usability and result interpretation
EUDAMED and Public Transparency
EUDAMED is the European database for medical devices that will, when fully operational, provide unprecedented transparency on device safety. The vigilance module will contain information on serious incidents and FSCAs, with certain information made publicly available.
EUDAMED Vigilance Module
Information Available to Public
- • Field Safety Notices
- • Summary safety reports after FSCA completion
- • Aggregated trend data on incident types
- • Links to competent authority safety communications
Restricted Information
- • Individual incident reports (to CAs and manufacturers)
- • Ongoing investigations (until concluded)
- • Patient-identifiable information
- • Commercially confidential details
Implications for Healthcare Workers
When fully operational, EUDAMED will allow healthcare workers to check for FSCAs affecting devices in their facility, review the safety history of devices being considered for procurement, and access FSNs directly. This transparency supports informed clinical decision-making and facilitates proactive safety management.
Case Study: Infusion Pump Software Vulnerability FSCA
Situation: A manufacturer of networked infusion pumps used extensively across European hospitals identified a cybersecurity vulnerability that could, under specific network conditions, allow unauthorised access to pump settings. While no actual exploitation had been reported, the potential risk to patient safety warranted a proactive FSCA.
Manufacturer Response:
- Reported to competent authority via EUDAMED within 2 days (serious public health threat)
- Developed software patch to close vulnerability
- Issued FSN to all customers with affected devices (identified via UDI database)
- Provided interim risk mitigation guidance (network isolation recommendations)
Hospital Response (Dutch Teaching Hospital):
- Received FSN via email to medical device department
- Cross-referenced affected model/software versions against asset register (340 pumps affected)
- Worked with IT department to implement network isolation as interim measure
- Scheduled software updates during planned maintenance windows over 6 weeks
- Returned acknowledgement confirming 100% completion to manufacturer
Key Lessons: The hospital's UDI-based asset register enabled rapid identification of affected devices. Coordination between medical device management, IT security, and clinical departments was essential. The 6-week implementation timeline was agreed with clinical areas to minimise disruption.
Case Study: IVD False Negative Detection Through Trend Analysis
Situation: A clinical laboratory in Portugal using a widely-deployed troponin assay for acute coronary syndrome diagnosis noticed an apparent increase in negative results being contradicted by clinical presentation and subsequent positive results on a different platform.
Laboratory Investigation:
- Retrospective analysis of quality control data showed subtle drift over 3 months
- EQA results remained within acceptable limits but showed consistent negative bias
- Clinical audit identified 12 cases where initial negative troponin may have delayed treatment
Reporting and Response:
- Laboratory reported concern to manufacturer via complaint process
- Manufacturer investigation revealed reagent stability issue in specific lot
- Trend report submitted to competent authority under Article 88 (trend of expected but increased side effect)
- FSCA issued for affected lot with recommendation to verify recent negative results
Outcome: The manufacturer updated their stability monitoring procedures and enhanced lot release testing. The laboratory implemented more frequent internal quality control and correlation studies with a second method for critical assays.
Case Study: Orthopaedic Implant Registry Signal Detection
Situation: The Swedish Hip Arthroplasty Register detected a higher-than-expected revision rate for a specific hip implant system within the first 3 years post-implantation. The signal was identified through routine registry analysis comparing observed versus expected revision rates.
Signal Investigation:
- Registry analysis showed 5-year revision rate of 8.2% versus 3.1% for comparator devices
- Revision reasons predominantly related to aseptic loosening of the acetabular component
- Signal shared with manufacturer as part of PMCF/PMS collaboration
Regulatory and Clinical Response:
- Manufacturer submitted trend report to competent authority
- Root cause investigation identified design feature contributing to loosening in certain patient anatomies
- Updated surgical technique guide issued as FSCA (IFU modification)
- Enhanced patient selection criteria communicated via FSN
- Surgeons advised to review patients with the implant and monitor for early signs of loosening
Healthcare Facility Actions (Swedish Hospitals):
- Identified patients with the affected implant via registry linkage
- Implemented enhanced follow-up protocol for at-risk patients
- Orthopaedic teams reviewed surgical technique guide updates
- Updated procurement criteria for future implant selection
Best Practices for Healthcare Facilities
Establish Robust Device Traceability
- Implement UDI scanning at receipt and point of use
- Maintain asset registers with UDI, location, and for implants, patient linkage
- Enable rapid identification of devices when FSCAs are received
- Regular audits to verify traceability data accuracy
Develop FSCA Response Procedures
- Designate responsibility for receiving and acting on FSNs
- Establish escalation pathways based on FSCA urgency
- Create templates for communicating FSCAs to clinical areas
- Track FSCA completion and maintain records
- Review FSCAs in device quality/safety meetings
Foster Incident Reporting Culture
- Make incident reporting easy with accessible forms/systems
- Provide training on recognising device-related incidents
- Ensure non-punitive reporting environment
- Provide feedback on reported incidents and outcomes
- Include device safety in quality improvement activities
Engage with Manufacturer PMS Activities
- Participate in manufacturer user surveys and feedback requests
- Consider participation in PMCF studies and registries
- Provide detailed information when reporting complaints
- Share performance data with manufacturers when requested
Key Takeaways for Healthcare Workers
PMS is continuous and proactive—manufacturers must actively collect and analyse post-market data throughout the device lifecycle.
Healthcare workers are essential to vigilance—you are often the first to identify incidents and your reports drive safety improvements.
Report to manufacturer AND your facility's incident system—ensure incidents are captured both for regulatory purposes and local safety improvement.
Preserve evidence when incidents occur—quarantine devices and document details to support investigation.
Traceability enables FSCA response—maintain accurate records linking devices to locations and patients.
EUDAMED will increase transparency—use it to check device safety history and access FSNs when fully operational.
Congratulations!
You have completed all six modules of the MDR/IVDR Compliance Learning Platform. You now have a comprehensive understanding of:
- • The regulatory framework and objectives of MDR and IVDR
- • Key changes from the previous directives
- • Roles and responsibilities of all stakeholders
- • Risk-based device classification systems
- • Clinical evaluation and performance study requirements
- • Post-market surveillance and vigilance obligations
This knowledge will support you in your role managing, procuring, and working with medical devices in compliance with EU regulations. Remember that regulations evolve—stay informed through competent authority communications, EUDAMED updates, and professional development opportunities.