Post-Market
Post-Market Surveillance Plan
In one line
Documented plan describing PMS activities, data sources, methods, and review frequency.
Definition
MDR Annex III requires a PMS Plan covering proactive and reactive collection of clinical data, complaints, registries, literature, similar-device data, and trend analysis. Drives PSURs, PMS Reports, and PMCF Plans.
The plan must also set out methods to assess the data, indicators and thresholds for benefit-risk reassessment, methods for complaint and trend analysis, communication with authorities and users, and links to CAPA and the PMCF plan. It is part of the technical documentation under Annex III and is reviewed by notified bodies. Under the IVDR, the equivalent plan covers post-market performance follow-up instead of PMCF.
Why it matters
A weak PMS Plan is a recurring Notified Body finding; reviewers want to see specific, measurable activities - not boilerplate.
Common pitfalls
- •A common pitfall is creating a generic PMS Plan that lacks specific, actionable tasks and measurable outcomes.
- •Failing to integrate lessons learned from PMS activities back into risk management and device design is a significant oversight.
- •Not allocating sufficient resources, both human and financial, to execute the PMS Plan effectively can lead to non-compliance.
- •Misinterpreting "proactive" surveillance as merely collecting complaints, rather than actively seeking data, is a frequent mistake.
- •Ignoring data from "similar devices" or publicly available information can result in an incomplete understanding of post-market risks.
Sources
- MDR Annex III · EUR-Lex
- FDA MAUDE Database · FDA
- FDA Recalls - Medical Devices · FDA