Post-Market Surveillance (PMS) Under EU MDR: How to Stay Compliant
What is Post-Market Surveillance Under EU MDR?
Post-Market Surveillance (PMS) is a proactive, systematic process for gathering and analysing data on the safety and performance of medical devices once they are on the market. Unlike pre-market assessments, which focus on initial conformity and risk evaluation, PMS ensures that devices continue to meet regulatory standards throughout their lifecycle.
Under the EU Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745, Article 83), manufacturers are required to establish and maintain a PMS system that aligns with the device’s risk classification, intended use, and complexity, as well as ensuring compliance with Articles 84, 85, and 86 for PMS documentation and reporting. A well-structured PMS framework allows manufacturers to:
Detect safety signals and emerging risks
Monitor real-world performance data
Implement corrective and preventive actions (CAPA) when necessary
By maintaining a robust PMS system, manufacturers can enhance patient safety, minimise regulatory risks, and ensure ongoing compliance with EU MDR requirements.
Why PMS is Essential for Medical Device Manufacturers
The primary goal of Post-Market Surveillance (PMS) is to improve device safety and effectiveness by identifying potential risks early and addressing them before they escalate. A well-executed PMS system enables manufacturers to:
Ensure continuous compliance – The EU MDR imposes stricter controls, requiring manufacturers to provide ongoing evidence of device safety and performance. A strong PMS system helps meet these regulatory demands.
Enhance patient safety – Systematic monitoring of post-market data allows manufacturers to detect and mitigate previously unnoticed risks.
Support clinical evaluation updates – Clinical evaluations must be regularly updated with real-world data. PMS provides critical clinical evidence to maintain regulatory approval.
Identify opportunities for product improvement – Market feedback can reveal areas for enhancement in functionality, design, or user experience.
Avoid regulatory penalties – Non-compliance with PMS requirements can lead to fines, product recalls, or loss of CE marking, which may result in removal from the EU market.
Essential PMS Requirements Under EU MDR
To comply with the EU Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745), manufacturers must establish a structured PMS system. This system should go beyond regulatory compliance and act as a proactive tool for product safety, performance, and risk management. Below are the key PMS requirements that manufacturers must meet
Developing a Robust PMS Plan
A well-structured Post-Market Surveillance (PMS) Plan is the foundation of a compliant PMS system. It must be designed to capture and analyse real-world data on device performance, identify emerging risks, and enable timely interventions when necessary. The PMS Plan should be proportionate to the device’s risk classification and intended use.
1. Key Components of an Effective PMS Plan
Methodologies for data collection and analysis – The plan should outline specific methods for gathering and evaluating PMS data, such as surveys, post-market clinical follow-ups, registry data, and complaint analysis.
Sources of PMS data – Manufacturers must collect real-world evidence (RWE) derived from real-world data (RWD) to support post-market surveillance efforts and clinical evaluation updates, including:
User feedback from healthcare professionals and patients
Clinical studies and observational research
Scientific literature reviews
Competitor product performance and recall data
Reports from regulatory authorities, notified bodies, and adverse event databases
Proactive and reactive data gathering – While manufacturers must respond to complaints and adverse events, they should also actively seek additional safety and performance data through structured post-market research.
Processes for risk identification and trend analysis – Risk assessment tools, such as Failure Modes and Effects Analysis (FMEA) and statistical trend analysis, help identify patterns in device performance and safety.
Reporting obligations for adverse events and safety signals – The PMS Plan must define the manufacturer’s responsibility to report serious incidents, implement corrective actions, and notify competent authorities as required.
A robust PMS Plan does more than just collect data - it enables manufacturers to use insights strategically to enhance patient safety and maintain compliance with EU MDR (Regulation (EU) 2017/745).
2. Maintaining a Post-Market Surveillance System
A Post-Market Surveillance (PMS) system must be fully integrated into the manufacturer’s Quality Management System (QMS) to ensure continuous monitoring of device safety and performance. The system should facilitate structured and ongoing data collection from multiple sources, including:
Clinical follow-ups – Real-world data collection or clinical studies that provide evidence of a device’s long-term safety and effectiveness.
Customer complaints – All complaints must be logged, investigated, and analysed to detect potential trends or recurring issues.
Incident reports – Manufacturers must track all incidents, from minor failures to serious adverse events, and implement corrective actions where necessary.
Market research and competitor analysis – Monitoring competitor recalls, safety notices, and adverse event reports helps assess industry-wide risks and emerging trends.
An effective PMS system enables manufacturers to make evidence-based decisions about product improvements, labelling updates, and safety measures. It also ensures compliance with EU MDR (Regulation (EU) 2017/745) by aligning with risk management and clinical evaluation processes.
3. Generating and Submitting Periodic Safety Reports
Under EU MDR (Regulation (EU) 2017/745), manufacturers must document and report Post-Market Surveillance (PMS) findings regularly to demonstrate continued compliance and device safety. The required type of report depends on the device classification:
Periodic Safety Update Report (PSUR)
Periodic Safety Update Report (PSUR) is mandatory for Class IIa, IIb, and III devices (Article 86).
It must be updated annually for Class IIb and III devices and every two years for Class IIa devices to reflect post-market surveillance findings and risk-benefit analyses.
Summarises PMS data, risk-benefit analyses, and any preventive or corrective actions taken.
For Class III and implantable devices, PSURs must be submitted to notified bodies for review.
Post-Market Surveillance Report (PMSR)
Required for Class I devices.
Provides a summary of PMS findings, which must be made available to regulatory authorities upon request.
These reports ensure regulatory oversight by authorities and notified bodies, confirming the ongoing safety, performance, and risk management of medical devices throughout their lifecycle.
4. Conducting Post-Market Clinical Follow-Up (PMCF)
A Post-Market Clinical Follow-Up (PMCF) Plan is required when additional clinical data is necessary to confirm a device’s long-term safety and performance, as mandated under Annex XIV, Part B of EU MDR. The plan must outline methods for continuous data collection and integration into risk management activities. PMCF is particularly important for:
Higher-risk devices, including Class III and implantable devices.
Innovative technologies, where pre-market data may be limited.
Devices with evolving risk-benefit profiles, requiring ongoing clinical evidence.
Key Objectives of a PMCF Study
Collect real-world clinical evidence from healthcare settings.
Identify emerging risks that may not have been apparent during the pre-market phase.
Update Clinical Evaluation Reports (CERs) with the latest safety and performance data.
Manufacturers must design PMCF activities carefully to generate meaningful clinical data, ensuring post-market evidence remains robust enough to support continued compliance with EU MDR (Regulation (EU) 2017/745).
5. Ensuring Vigilance and Incident Reporting Compliance
Under EU MDR (Regulation (EU) 2017/745), vigilance reporting is a critical requirement that ensures swift regulatory and manufacturer responses to safety concerns. Manufacturers must adhere to strict reporting timeframes as per EU MDR Article 87, for serious incidents and Field Safety Corrective Actions (FSCAs):
Serious public health threats – Report within two days of awareness.
Serious incidents – Report within ten days of awareness.
Other reportable incidents – Report within fifteen days of awareness.
These reports must be submitted via EUDAMED (Article 92) to ensure centralised EU regulatory oversight.
6. Implementing Field Safety Corrective Actions (FSCAs)
When necessary, manufacturers must take corrective actions to mitigate risks, including:
Issuing safety notices to healthcare professionals and patients.
Conducting product recalls or modifications.
Updating labelling, instructions for use (IFU), or contraindications.
Failure to comply with vigilance reporting requirements can result in regulatory sanctions, loss of CE marking, or market withdrawal. Ensuring timely and accurate reporting is essential for maintaining compliance and protecting patient safety.
7. Implementing Corrective and Preventive Actions (CAPA)
When Post-Market Surveillance (PMS) data highlights safety concerns, manufacturers must implement Corrective and Preventive Actions (CAPA) to mitigate potential risks. This process should be structured and documented within the manufacturer’s Quality Management System (QMS).
Key CAPA Measures
Product modifications –If modifications result in significant changes to intended use, clinical evaluation, or risk profile, they must be reviewed by a Notified Body before implementation, as per Article 52.
Labelling updates – Revisions to usage instructions, warnings, or contraindications.
Additional clinical investigations – Further studies to validate long-term safety and effectiveness.
Market withdrawals – If a device poses unacceptable risks, removal from the market may be necessary.
A structured CAPA process ensures that PMS findings drive real-world improvements, safeguarding patients while maintaining compliance with EU MDR (Regulation (EU) 2017/745).
1. Adopt a Proactive Approach to Data Collection
Many manufacturers take a reactive approach, relying on customer complaints, adverse event reports, and regulatory feedback. While these are essential, they are not sufficient under EU MDR. Instead, manufacturers must implement a proactive and systematic PMS strategy by:
Collecting real-world evidence (RWE) – Gathering data from routine clinical use, observational studies, and patient registries.
Monitoring emerging risks and trends – Analysing patterns in complaints, incident reports, and competitor recalls.
Implementing early risk mitigation strategies – Addressing safety concerns before they escalate into serious incidents or regulatory warnings.
A proactive PMS strategy not only ensures compliance but also reduces regulatory risks, strengthens product reliability, and enhances patient safety.
2. Invest in Digital PMS Solutions
EU MDR requires manufacturers to maintain extensive PMS records, including risk assessments and regulatory reports. Managing these tasks manually increases the risk of errors and inefficiencies. Digital PMS solutions can help by:
Automating data collection from complaint management systems, regulatory databases, and clinical registries.
Streamlining trend analysis and risk evaluation – AI and machine learning tools can detect potential safety signals early.
Ensuring compliance with reporting deadlines, reducing the risk of penalties or regulatory action.
A compliant PMS system must also align with ISO 13485:2016 (Quality Management System for Medical Devices), ensuring structured data analysis, traceability, and risk management. By implementing cloud-based PMS software, manufacturers can enhance data accuracy, improve compliance efficiency, and enable real-time decision-making.
3. Train Personnel Regularly on PMS Regulations and Best Practices
PMS compliance is not just the responsibility of regulatory teams - it requires collaboration across product development, quality assurance, and customer service. To ensure a company-wide commitment to PMS compliance, manufacturers should:
Provide regular training on EU MDR requirements, vigilance reporting obligations, and risk management best practices.
Educate employees on identifying and reporting safety concerns, ensuring that front-line staff - such as sales representatives and service teams - contribute valuable real-world insights.
Foster a culture of regulatory awareness, making PMS compliance an ongoing responsibility rather than an afterthought.
A well-trained workforce strengthens PMS effectiveness, reduces compliance risks, and supports continuous product monitoring.
4. Engage with Healthcare Professionals and Patients
Direct feedback from users - such as healthcare professionals, hospitals, and patients - is a valuable source of PMS data. Manufacturers should implement structured processes to gather post-market insights by:
Collaborating with clinicians – Engaging with physicians, surgeons, and nurses to collect real-world insights into device performance, usability issues, and potential risks.
Encouraging patient feedback – Patient-reported outcomes provide crucial data on device effectiveness, side effects, and long-term performance.
Participating in post-market registries – Contributing to national and European medical device registries to track long-term safety and effectiveness trends.
By actively engaging with end-users, manufacturers can enhance device performance, improve user experience, and identify emerging risks at an early stage.
Conclusion
Post-Market Surveillance (PMS) under EU MDR is not just a regulatory requirement - it is a critical process for ensuring ongoing safety, efficacy, and reliability of medical devices.
By implementing a structured PMS strategy, manufacturers can:
✔ Detect and mitigate emerging risks early, preventing safety concerns from escalating.
✔ Maintain compliance with EU MDR requirements, avoiding regulatory penalties.
✔ Enhance product quality and reliability, fostering greater market trust and customer satisfaction.
To achieve PMS excellence, manufacturers should:
🔹 Adopt proactive data collection practices to identify risks before they become critical.
🔹 Invest in digital PMS solutions for efficient data management and compliance tracking.
🔹 Engage with healthcare professionals and patients to gather real-world performance insights.
🔹 Continuously update technical documentation to reflect the latest safety and performance data.
By staying ahead of regulatory requirements, manufacturers can ensure compliance while strengthening their reputation as leaders in medical device safety and innovation.