What is the difference between PMS and PMCF?

In short: Post-market surveillance (PMS) is the umbrella system for collecting and acting on real-world data about your device after launch. Post-market clinical follow-up (PMCF) is its clinical sub-part: proactively gathering clinical evidence to keep the CER current. Both are planned before certification, not after.

PMS: the umbrella system

Post-market surveillance is the broader obligation every MDR manufacturer has (MDR Articles 83–86): a documented, proactive system for collecting and evaluating experience gained from devices already on the market — complaints, incident reports, trend data, user feedback — and feeding it back into your risk management file and technical documentation. It's not passive record-keeping; MDR expects a defined process with a named owner (often the PRRC) and a plan describing how the data gets collected, analysed, and acted on. The reporting deliverable scales with class: Class I devices produce a PMS report (Article 85), Class IIa and above a periodic safety update report, or PSUR (Article 86).

PMCF: the clinical piece inside it

Post-market clinical follow-up (MDR Annex XIV Part B) is the subset of PMS specifically about clinical evidence: proactively generating or collecting clinical data after launch to confirm your device continues to perform safely as intended, and to keep your clinical evaluation report current rather than letting it go stale as real-world use accumulates. For higher-class or higher-risk devices — What is the difference between Class I, IIa, IIb, and III? — PMCF often needs a dedicated plan and study design, not just passive complaint monitoring; the depth expected scales with the device's risk profile and how much your pre-market clinical evidence relied on equivalence rather than your own data. PMCF isn't automatically required, though — where it's not deemed appropriate for a lower-risk device, that's permissible, but the rationale must be documented in the PMCF plan and CER (Annex XIV Part B §6.2), not simply skipped.

Why both need to be planned before certification

A Notified Body reviews your PMS and PMCF plans as part of the technical file, before you're certified — not as something you draft after launch. Treating either as a post-launch afterthought both risks a finding during review and, more practically, leaves you without a real process the moment you actually need it: the first serious complaint or adverse event report is the wrong time to be designing your surveillance system from scratch.

Where next: Building an MDR Technical File and CER · What is a clinical evaluation report (CER)?

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