Post-Market Surveillance
Post-Market Surveillance Knowledge Check
EUDAMED Registration Obligations by Economic Operator Type
Who must register in EUDAMED, what each economic operator type is required to do, and the practical steps to meet your obligations as a manufacturer, authorised representative, importer, or distributor.
PSUR vs PMSR: Class-Based Reporting Requirements Under EU MDR
The difference between a Periodic Safety Update Report and a Post-Market Surveillance Report, which device classes require each, and the update intervals that apply.
How to Structure a PMS Plan Under EU MDR
What a compliant PMS plan must contain, how to define signals and thresholds, and where most teams go wrong when writing it for the first time.
Vigilance Reporting Under EU MDR: Serious Incidents, Timelines, and Competent Authority Routes
What counts as a serious incident under MDR, the reporting timelines that apply, how to route reports to competent authorities, and how trend reporting works alongside individual incident reports.
How PMS Outputs Connect Back to Technical Documentation and Clinical Evaluation
How the outputs of your post-market surveillance system feed back into risk management, your clinical evaluation report, and the technical documentation — and what triggers a mandatory update cycle.
PMS Data Sources and Thresholds in Practice
What counts as a PMS signal, how to set actionable thresholds, and which data sources actually deliver useful information versus which ones just look good on paper.
PMCF Evaluation Report: The PMS-Side Document
How the PMCF evaluation report differs from the PMCF plan, what it must demonstrate, and how it feeds back into your clinical evaluation and PMS system.
Trend Reporting and Serious Incident Classification Under MDR
How to classify serious incidents correctly, what trend reporting requires when events are below the serious incident threshold, and the difference between MIR and FSN obligations.
National Competent Authority Expectations for PMS
How PMS expectations vary across EU member states, which national databases matter, and what practical differences manufacturers encounter when reporting to different competent authorities.
Legacy Device PMS Obligations Under MDR
PMS requirements for MDD-certified devices during MDR transition, what Article 120 devices must maintain, and where legacy status does and does not reduce your obligations.
Post-market surveillance is one of the areas where the gap between the old MDD world and MDR is most visible. Under MDD, many manufacturers treated post-market activity as a box to check — collect some complaints, write a brief report, move on. MDR makes that approach untenable. Articles 83 to 86 establish a genuine system requirement: PMS must be planned, actively run, and its outputs must feed back into your risk management file, your clinical evaluation, and your technical documentation. If those connections aren't there, it's not a PMS system — it's a filing cabinet.
The PMS plan is where most teams should start, and it's where many go wrong. A plan that just lists data sources without specifying thresholds, review frequencies, or what happens when a signal is detected will not satisfy a Notified Body. One thing that catches teams off guard: the plan needs to define in advance what constitutes a signal significant enough to trigger a technical file update or a PSUR revision. Auditors look for that specificity. Vague plans tend to produce vague outputs.
The reporting structure depends on your device class. Class I devices require a post-market surveillance report (PMSR), updated when needed. Class IIa, IIb, and III devices require a periodic safety update report (PSUR), updated at defined intervals — at minimum every year for Class IIb and III, every two years for Class IIa. The PSUR is not the same as the PMCF evaluation report, and conflating the two is a common source of audit findings. The PSUR synthesises all post-market data to assess the overall benefit-risk of the device; the PMCF evaluation report is one input into it.
Vigilance — the incident reporting side of PMS — runs on its own track under Articles 87 to 92. Serious incidents must be reported to the relevant competent authority, and trends that fall below the serious incident threshold but suggest a systematic issue also trigger reporting obligations. EUDAMED is central to both vigilance reporting and broader registration obligations. EUDAMED's modules have rolled out in phases, and the registration requirements are not always well understood — particularly for economic operators other than the manufacturer.
Resources in this category cover building a PMS plan from scratch, the PSUR structure and what it needs to contain, vigilance reporting timelines and thresholds, EUDAMED registration obligations, and how your PMS outputs connect back to technical documentation updates and clinical evaluation cycles. If you are setting up PMS for the first time or reviewing what you have ahead of an audit, the plan and PSUR structure resources are the right starting point.
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