What this guide covers
The difference in one sentence
A PMS Report (PMSR) is the post-market surveillance summary required for Class I devices under Article 85, while a PSUR is the more detailed report required for Class IIa, IIb and III devices under Article 86 — adding a benefit-risk conclusion, PMCF findings and sales/usage data, and, for the highest-risk devices, active review by a Notified Body.
Same system, two outputs
The most useful thing to understand first is that the PMSR and the PSUR are not two different processes. They are two possible outputs of the same underlying post-market surveillance system that every manufacturer must run under Article 83, driven by the PMS plan under Article 84. Both summarise the results and conclusions of the PMS data you collect, and both describe any preventive or corrective actions (CAPA) you took. The difference is how much more the PSUR demands on top of that shared core — and who gets to see it. (For the full picture of the obligations these reports sit within, see our guide to EU MDR Articles 83–92.)
What is a PMS Report (PMSR)?
The PMS Report is defined in Article 85 and applies to Class I devices. It summarises the results and conclusions of the analysis of your post-market surveillance data, together with a rationale and description of any preventive and corrective actions taken.
Two things make it lighter-touch than a PSUR:
- It is updated when necessary — there is no fixed calendar interval.
- It is kept available to competent authorities on request; you do not submit it routinely, and there is no standard Notified Body review cycle for it.
What is a PSUR?
The Periodic Safety Update Report is defined in Article 86 and applies to Class IIa, IIb and III devices. It contains everything a PMSR does, and then adds the elements that let a reviewer judge whether the device's benefit-risk balance still holds:
- The conclusions of the benefit-risk determination.
- The main findings of post-market clinical follow-up (PMCF).
- The volume of sales, plus an estimate of the size and characteristics of the population using the device and, where practicable, its usage frequency.
Unlike the PMSR, the PSUR runs on a fixed update cycle and, for higher-risk devices, is actively reviewed rather than merely held on file.
Side-by-side comparison
| PMS Report (PMSR) | PSUR | |
|---|---|---|
| Regulation | Article 85 | Article 86 |
| Applies to | Class I | Class IIa, IIb, III |
| Shared core | PMS data results & conclusions + rationale and description of any CAPA | |
| Extra content | — | Benefit-risk conclusions, PMCF findings, sales volume, user-population estimate |
| Update frequency | When necessary | Class IIa: when necessary and at least every 2 years · Class IIb & III: at least annually |
| Who sees it | Competent authorities, on request | Class III & implantable: submitted via Eudamed to the Notified Body, which reviews and evaluates it · Class IIa & IIb: made available to the Notified Body and, on request, to competent authorities |
| Part of technical documentation | Yes | Yes |
Which one does your device need?
It comes down to classification:
- Class I → PMS Report (Article 85).
- Class IIa, IIb or III → PSUR (Article 86).
You prepare the report per device, though the MDR allows you to prepare it for a category or group of devices, and MDCG guidance lets you group devices that share a Basic UDI-DI into a single PSUR where defined conditions are met. If part of your portfolio is Class I and part is higher-risk, you will be producing both types of report in parallel.
Common mistakes
- Treating them as interchangeable. A PSUR is not just a PMSR with a new title — missing the benefit-risk conclusion, PMCF findings or sales/usage data is a frequent nonconformity.
- Missing the PSUR clock. The PMSR has no fixed interval, but PSURs are due at least every two years (IIa) or annually (IIb, III). Late submission for Class III can escalate to certificate suspension.
- Forgetting the data behind it. Both reports are only as good as the PMS data feeding them. If your surveillance is a once-a-quarter manual sweep, the report reflects that — and so does the audit finding.
Keeping either report current
Whichever report you owe, it draws on the same raw material: real-world signals about your device from adverse-event databases, recall notices, literature, clinical-trial data and the open market. The hard part is rarely writing the document — it's keeping that underlying data current and being able to show where each conclusion came from.
Automating the external-signal side of surveillance — continuously monitoring sources like FDA MAUDE, recall notices, clinical-trial registries and unauthorised marketplace listings, and logging every finding with a timestamp — means your PMSR or PSUR is built from live data rather than assembled from scratch each cycle, with a ready-made evidence trail behind every statement. It complements your QMS and clinical evaluation rather than replacing them.
See what your surveillance data looks like
MedFortis runs a free PMS Gap Scan against your device lines and shows you, live, what's surfacing across FDA data, recalls, trials and the open market — the raw material behind your PMSR or PSUR.
Request your free PMS Gap Scan →Key takeaways
- PMSR (Article 85) is for Class I; PSUR (Article 86) is for Class IIa, IIb and III.
- Both share a core (PMS data conclusions + CAPA); the PSUR adds benefit-risk, PMCF findings and sales/usage data.
- PMSR: updated when necessary, held for authorities on request. PSUR: fixed cycle (2 years for IIa; annual for IIb/III).
- Class III and implantable PSURs are submitted via Eudamed and reviewed by the Notified Body; other classes are made available on request.
- Both are only as strong as the PMS data behind them — which is where continuous monitoring pays off.