Article 79 and Annex III of the IVDR require every manufacturer to plan, establish, document, implement, maintain, and update a post-market surveillance system proportionate to the risk class and appropriate for the type of device. The PMS Plan defines the data sources (complaints, PMPF, literature, registries), the indicators and thresholds, and the linkage back into risk management and the performance evaluation.

Why it matters

For Class A and B devices the outputs feed a PMS Report (Article 80); for Class C and D they feed a Periodic Safety Update Report (PSUR, Article 81) that is reviewed by the notified body for Class C and D and, for Class D, made available through EUDAMED.

Common pitfalls

•A common mistake is creating a generic PMS Plan that does not adequately reflect the specific risks, intended use, or type of a particular IVD, failing to meet the proportionality requirement of Article 79.
•Manufacturers often fail to establish clear indicators and thresholds for when a signal constitutes a potential safety concern, leading to reactive rather than proactive post-market surveillance activities.
•Another pitfall is not ensuring a robust feedback loop from PMS activities back into the risk management process and performance evaluation, which is critical for ongoing device safety and effectiveness updates.

Sources

Regulation (EU) 2017/746, Article 79 and Annex III · EUR-Lex
IMDRF Documents · IMDRF
RAPS Regulatory Focus · RAPS

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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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