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Post Market Surveillance Report (PMSR) for Medical Device
The Post Market Surveillance Report (PMSR) is a mandatory regulatory document that every medical device manufacturer must prepare and maintain as part of their MDR CE Marking technical documentation under EU MDR 2017/745. Under Article 85 of the MDR, Class I device manufacturers must produce a PMSR, while Class IIa, IIb, and Class III manufacturers are required to produce a Periodic Safety Update Report (PSUR) under Article 86. Regardless of device classification, a PMS Report is not optional — it is a legal obligation and a core component of your MDR technical file.
At I3CGlobal, our medical device consultants specialize in preparing, reviewing, and updating PMSR and PSUR documentation for manufacturers seeking MDR CE Marking across all device classes. Our team ensures your post market surveillance report meets Annex III requirements, satisfies Notified Body expectations, and reflects real-world device performance data.
What is a Post Market Surveillance Report (PMSR) Under EU MDR 2017/745?
Under EU MDR 2017/745, a Post Market Surveillance Report (PMSR) is defined in Article 85 as a proactive, systematic process through which medical device manufacturers collect, record, and analyze real-world data on the quality, safety, and performance of their device throughout its entire product lifecycle. The PMSR is based on a Post Market Surveillance Plan (PMS Plan) that must be included in the technical documentation and must address all data sources as outlined in Annex III of the MDR.
The conformity assessment procedures defined in Annexes IX to XI of the MDR require manufacturers to create and maintain a PMSR mechanism that is proportional to the device’s risk class. Article 2, Section 60 of the MDR defines PMS as a proactive process involving the manufacturer and other economic operators — including importers, distributors, and authorized representatives — to implement corrective and preventive action (CAPA) based on post-market data.
The medical device post market surveillance system actively and systematically gathers, records, and analyzes relevant data on device quality, performance, and safety. This allows manufacturers to continuously update their risk-benefit assessment and initiate necessary corrective measures without delay.
PMSR as Part of MDR Technical Documentation — What Does the Law Require?
Yes — a Post Market Surveillance Report (PMSR) is a mandatory part of your MDR technical documentation. Under MDR 2017/745, both Annex II (Technical Documentation) and Annex III (Technical Documentation on Post-Market Surveillance) explicitly state that the PMS Plan and the resulting PMSR or PSUR are non-negotiable components of the technical file.
During a Notified Body audit or Competent Authority inspection, the absence of an updated PMSR will be flagged as a major non-conformity. The MDR takes a lifecycle approach to medical device regulation — while clinical evaluation demonstrates pre-market safety, the PMSR closes the loop by feeding real-world performance data back into your Clinical Evaluation Report (CER), Risk Management File (ISO 14971), and General Safety and Performance Requirements (GSPR).
Medical device manufacturers must establish a cross-functional post market surveillance team that collaborates with the regulatory, quality, clinical, and technical teams to design, implement, and maintain the PMSR system. I3CGlobal’s MDR consultants support manufacturers at every stage of this process.
Key Requirements of a Compliant MDR Post Market Surveillance Report
A compliant Post Market Surveillance Report under EU MDR 2017/745 is no longer a static regulatory checkbox. It is a dynamic, living document that must demonstrate a proactive surveillance system, integrate clinical follow-up data, and continuously re-evaluate the device’s benefit-risk profile. Here are the five core requirements your PMSR must address:
Proactive Post Market Data Collection Strategy
Unlike the reactive approach under the legacy MDD, a compliant MDR PMSR must demonstrate that your surveillance system actively seeks out performance and safety data — not just responds to complaints.
Unlike the older MDD approach, which was often reactive (waiting for complaints), a good PMS report demonstrates a proactive system.
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Active Surveillance: Includes user feedback, surveys, and literature reviews.
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PMCF Integration: If your device is high-risk or uses new technology, the report must include data from your Post-Market Clinical Follow-up (PMCF) plan to validate long-term safety.
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Benchmarking: It must compare your device’s performance against “state-of-the-art” (SOTA) or similar devices currently on the market.
Statistical Trend Analysis and Signal Detection
A key requirement of the MDR PMSR is demonstrating that your surveillance system can identify emerging safety signals before they become critical failures or reportable incidents.
A key feature of a compliant report is the ability to identify shifts in device safety before they become critical failures.
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Thresholds and Indicators: The report should define clear “trigger” points. If a complication rate exceeds a pre-defined threshold, the report must document the subsequent investigation.
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Trend Analysis (Article 88): You must show techniques for identifying statistically significant increases in the frequency or severity of non-serious incidents.
Benefit-Risk Re-Evaluation Based on Real-World Data
The Post Market Surveillance Report is the primary tool for updating the Benefit-Risk Analysis.
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Continuous Loop: It should confirm whether the clinical benefits still outweigh the risks based on real-world data.
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Risk Management Link: Any new risks identified in the field must be fed back into the Risk Management File (ISO 14971).
CAPA Integration and Field Safety Corrective Actions (FSCA)
A “good” report doesn’t just list problems, it lists solutions for every problems and also details how the problems are mitigated. It must detail:
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Corrective and Preventive Actions (CAPA): Any design changes, labeling updates, or manufacturing adjustments made in response to gathered data.
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Field Safety Corrective Actions (FSCA): Documentation of any recalls or safety notices issued during the period.
MDR Article 85 vs Article 86 — PMSR vs PSUR: What's the Difference?
The structure and frequency of your post market surveillance reporting depends on your device’s risk classification under the MDR:
| Feature | PMS Report (Art. 85) | PSUR (Art. 86) |
|---|---|---|
|
Device Class |
Class I |
Class IIa, IIb, and III |
| Update Frequency | When necessary (available to authorities) | At least annually (Class IIb/III) or every 2 years (IIa) |
| Main Focus | Summary of surveillance results | Main findings, benefit-risk conclusion, sales volume |
How Does the PMSR Connect With ISO 13485 and Your QMS?
The Post Market Surveillance Report must be fully integrated into your Quality Management System (QMS) in accordance with ISO 13485:2016, Section 8.2.1. The PMSR is not a standalone document — it forms the evidence base for your QMS outputs, including CAPA records, risk management updates, and clinical evaluation reports.
PMS activities fall into two categories. Reactive surveillance responds to events that have already occurred and includes data from customer complaints, literature reviews, user feedback, maintenance and service reports, failure analysis, in-house testing, device registries, and social media monitoring. Proactive surveillance anticipates and prevents events before they occur through customer surveys, PMCF studies, implant registries, and expert user group feedback.
Because ISO 13485 applies to all medical devices on the market globally, your post market surveillance strategy must be developed in parallel with your proactive medical device PMS plan. MDR Article 87 further requires the Person Responsible for Regulatory Compliance (PRRC) to ensure that the PMS system is updated proactively, comprehensively, and systematically in accordance with EU MDR 2017/745.
| REACTIVE Sources |
|---|
| Customer complaints |
| Literature reviews |
| User feedbacks |
| Maintenance/Service Reports |
| Failure analysis |
| In-house testing |
| Device registries |
| Social media |
| PROACTIVE Sources |
|---|
| Customer surveys |
| PMCF or other post CE clinical trials |
| Implant registries |
| Expert user groups |
GSPR Updates Driven by Post Market Surveillance Report Findings
Under EU MDR 2017/745, the General Safety and Performance Requirements (GSPR) set out in Annex I are not static. Manufacturers are obliged to update their GSPR checklist whenever post market surveillance data reveals new risks, changes in device performance, or shifts in the state-of-the-art. The Post Market Surveillance Report is the primary mechanism through which these updates are triggered and documented.
This creates a direct regulatory loop: PMSR findings must be fed back into the Risk Management File (ISO 14971), the Clinical Evaluation Report (CER), and the GSPR checklist — and any required labeling changes, design modifications, or field safety corrective actions must be initiated accordingly. Manufacturers who fail to update their GSPR in response to PMSR findings risk major non-conformities during Notified Body audits.
Buy easy-to-edit Microsoft Word post market surveillance report template prepared by subject experts for sale. All Templates are made as per the requirements of EN ISO 13485:2016, section 8.2.1 and MEDDEV NB-MED/2.12/Rec.1 guideline
General Safety and Performance Requirements must be updated in response to Post market surveillance report collection and output by the manufacturer placing the device on the market.
Get an expert-prepared, editable Microsoft Word PMSR template built to EU MDR 2017/745 and ISO 13485:2016 requirements.
Frequently Asked Questions
What is a Post Market Surveillance Report (PMSR) under EU MDR 2017/745?
A Post Market Surveillance Report (PMSR) is a mandatory regulatory document required under Article 85 of EU MDR 2017/745 for Class I medical device manufacturers. It summarizes the results of all post-market surveillance activities conducted over a defined period, evaluates the continued safety and performance of the device, and updates the benefit-risk analysis based on real-world data. The PMSR must be prepared based on the PMS Plan (Article 84) and must form part of the MDR technical documentation. Class IIa, IIb, and Class III devices require a Periodic Safety Update Report (PSUR) under Article 86 rather than a PMSR.
Is a PMSR mandatory for all medical device manufacturers under MDR?
Yes. All medical device manufacturers placing devices on the EU market under MDR 2017/745 are required to maintain a post market surveillance system and produce either a PMSR (for Class I devices, under Article 85) or a PSUR (for Class IIa, IIb, and III devices, under Article 86). There are no exemptions based on device size, volume, or manufacturer location. The absence of an up-to-date PMSR or PSUR is treated as a major non-conformity during Notified Body audits and Competent Authority inspections.
How often must the Post Market Surveillance Report be updated?
The update frequency depends on device class. For Class I devices, the PMSR must be updated whenever significant new information is available — there is no fixed frequency, but it must always be current and available upon request by authorities. For Class IIa devices, the PSUR must be updated at least every two years. For Class IIb and Class III devices, the PSUR must be updated annually. In all cases, the report must reflect the most recent post-market surveillance data and any changes to the device’s benefit-risk profile.
What is the difference between a PMSR and a PSUR under MDR?
Both documents are outputs of the post market surveillance system, but they differ in scope, frequency, and the device classes they apply to. The PMSR (Post Market Surveillance Report) under Article 85 applies to Class I medical devices and is updated when significant new data becomes available. The PSUR (Periodic Safety Update Report) under Article 86 applies to Class IIa, IIb, and Class III devices and must be updated annually (Class IIb/III) or every two years (Class IIa). The PSUR is more detailed and must include sales volume data, an estimate of the population exposed to the device, and the main findings of the post-market surveillance activities.
What data sources must be included in a medical device post market surveillance report?
A compliant MDR Post Market Surveillance Report must draw from both reactive and proactive data sources. Reactive sources include customer complaints, field safety corrective actions (FSCAs), adverse event reports, literature reviews, service and maintenance records, and device registry data. Proactive sources include customer surveys, PMCF studies, implant registry data, expert user group consultations, and benchmarking against similar devices on the market. The PMS Plan must define how data from all these sources is collected, recorded, analyzed, and used to update the benefit-risk assessment and the GSPR checklist.
How is the Post Market Surveillance Report connected to the Clinical Evaluation Report (CER)?
The Post Market Surveillance Report and the Clinical Evaluation Report (CER) are directly connected in a continuous regulatory feedback loop under EU MDR 2017/745. Post-market surveillance data — including real-world performance data, complaint trends, and PMCF study results — must be fed back into the CER to keep it current. The PMSR or PSUR provides the post-market evidence that updates the clinical claims, benefit-risk conclusions, and the state-of-the-art assessment within the CER. A CER that is not updated with PMSR findings will be considered non-compliant during Notified Body review.
Can I3CGlobal prepare our Post Market Surveillance Report and PMS Plan?
Yes. I3CGlobal is a specialist medical device regulatory consultancy with extensive experience preparing Post Market Surveillance Reports (PMSR), PMS Plans, and Periodic Safety Update Reports (PSUR) for medical device manufacturers seeking MDR CE Marking. Our team of regulatory consultants prepares all PMS documentation in compliance with EU MDR 2017/745, Annex III, ISO 13485:2016, and MDCG guidance. We support manufacturers across all device classes — Class I, IIa, IIb, and III — and work alongside your clinical evaluation, technical documentation, and quality teams to deliver a fully integrated PMSR that will withstand Notified Body scrutiny.
What happens if my Post Market Surveillance Report is missing or out of date?
A missing or outdated Post Market Surveillance Report is treated as a major non-conformity under EU MDR 2017/745. During a Notified Body technical file review or QMS audit, auditors will specifically check for a current, evidence-based PMSR or PSUR. If it is absent, incomplete, or not updated in response to new data, the Notified Body may issue a major non-conformity finding, which can delay or block your CE Marking certificate. In severe cases, Competent Authorities can also require market withdrawal of non-compliant devices. Manufacturers should treat the PMSR as a living document that is continuously maintained, not a one-time exercise.