EU MDR · Medium · 13 min lesson
Post-market surveillance system, PMS plan, PSUR and trend reporting
EU MDR 2017/745 Articles 83 to 86 and 88, Annex III, MDCG 2022-21
What you will learn
- Describe the PMS system and plan required by Articles 83 and 84 and Annex III, with indicators and thresholds.
- Choose the Article 85 report or the Article 86 PSUR by device class and state the update frequency and submission route.
- Set up Article 88 trend detection, run a worked trend calculation and tell a weak surveillance record from a compliant one.
Key takeaways
- Article 83: a documented PMS system, proportionate to class, collecting data actively and systematically and feeding risk management (Article 83(3)).
- Article 84 and Annex III section 1.1: the plan sets sources, methods, indicators, thresholds, trend method and a PMCF plan or justification.
- Class I: Article 85 report. Class IIa: PSUR at least every two years. Class IIb and III: PSUR at least annually (Article 86).
- Article 88: report statistically significant increases of non-serious incidents or expected side-effects that affect benefit-risk; method and period sit in the plan.
- Auditors want records of decisions: dated analyses, named approvers and visible changes to the risk file.
Free practice question
For two years Corvane Orthopaedics logged surgeon calls about squeaking and early loosening of its class III hip stem in a spreadsheet. Each was closed as non-serious. Nobody counted them by quarter, compared them with the clinical evaluation baseline or told the risk manager.
What is the main deficiency in how Corvane runs its surveillance?
None: logging complaints in a spreadsheet satisfies Article 83.
Not quite. Article 83(2) requires active and systematic analysis of data, which a log with no analysis does not provide.
There is no plan with indicators and thresholds, and no analysis that feeds risk management.
Correct. Article 84 with Annex III section 1.1 requires a plan with thresholds, and Article 83(3) requires use of the conclusions.
The complaints should have been reported to the notified body one by one.
Not quite. Article 87 covers serious incidents only, so non-serious complaints are not individually reported to a notified body.
The surgeons should stop phoning in reports.
Not quite. Reports from users are a needed source under Article 83, so discouraging them would weaken the system.
Key terms
- post-market surveillance: All activities by which the manufacturer systematically gathers and analyses experience from devices on the market (Article 83).
- PMS plan: The documented plan, part of the technical documentation, defining sources, methods, indicators and thresholds (Article 84, Annex III section 1.1).
- PSUR: Report for class IIa, IIb and III devices summarising PMS analysis, benefit-risk conclusions, PMCF findings and exposure (Article 86).
- PMS report: The Article 85 report for class I devices, updated when necessary.
- trend reporting: Reporting a statistically significant increase in non-serious incidents or expected side-effects with impact on benefit-risk (Article 88).
- indicator and threshold: A measured value and the level at which review or action is triggered (Annex III section 1.1).
- PMCF: Post-market clinical follow-up, the proactive collection of clinical data on a CE-marked device (Annex XIV Part B).
- Eudamed: The European database for medical devices, introduced in stages; the vigilance and PMS module was not yet mandatory in late 2025.
Official sources
- MDR Article 86 - Periodic safety update report
- MDR Article 88 - Trend reporting
- MDR Article 83 - Post-market surveillance system of the manufacturer
- MDCG 2022-21 PSUR guidance explained
- EU triggers mandatory Eudamed use from May 2026 (Decision (EU) 2025/2371)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.