Post-Market Surveillance (PMS) comprises the systematic processes a manufacturer establishes to actively collect and review experience gained from devices placed on the market, in order to identify any need to apply corrective or preventive actions. Under the EU MDR (Articles 83 to 86) and IVDR (Articles 78 to 81), every manufacturer must run a PMS system proportionate to risk class, described in a PMS plan, with outputs in a PMS report or PSUR. In the US, PMS is spread across complaint handling, medical device reporting, corrections and removals and, for some devices, FDA-ordered section 522 studies. PMS data must feed back into risk management, clinical evaluation and CAPA.

Why it matters

PMS is required under EU MDR Articles 83-86 and IVDR Articles 78-81, and is embedded in FDA's Quality System Regulation (soon QMSR) through complaint handling (820.198), CAPA (820.100), and MDR reporting (Part 803). Under EU MDR, manufacturers must maintain a PMS plan proportionate to device risk (Article 84), covering active and reactive data collection: vigilance and serious incidents, trend reports (Article 88), user feedback, scientific literature, similar-device data, PMCF for Class IIa and above, and PMS reports (Class I) or PSURs (Class IIa+). Outputs feed the risk management file, technical documentation, clinical evaluation, and, where needed, corrective actions and field safety corrective actions (FSCA).

Common pitfalls

•Confusing PMS (proactive, plan-driven) with vigilance (reactive, incident-driven). MDR Article 83 explicitly distinguishes them; you need both.
•Under-scoping PMS to complaints only. MDR expects trend analysis, literature review, similar-device data, and PMCF results as well.
•Missing the trend reporting obligation. MDR Article 88 requires reporting statistically significant increases in non-serious incidents or expected side effects.
•Treating PMS as separate from the RMF. PMS outputs must be linked to risk analysis updates and, where relevant, to CAPA.

Sources

EU MDR Chapter VII (Post-Market Surveillance) · EUR-Lex
MDCG 2022-21 PSUR Template · European Commission
FDA Recalls - Medical Devices · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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