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Post-MarketPost-Market & Safety
Post-Market Surveillance Plan
Documented plan describing PMS activities, data sources, methods, and review frequency.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
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. What the regulation says
The EU Medical Device Regulation (MDR) 2017/745, specifically Article 84 and Annex III, mandates that manufacturers establish, document, implement, and maintain a Post-Market Surveillance (PMS) Plan. This plan is an integral part of the technical documentation for a device and outlines the proactive and systematic process for collecting, recording, and analyzing data on the quality, performance, and safety of a device throughout its entire lifecycle. The FDA similarly expects manufacturers to have a robust system for post-market surveillance under 21 CFR Part 820.
What this means in practice
A weak PMS Plan is a recurring Notified Body finding; reviewers want to see specific, measurable activities - not boilerplate.Examples
- A manufacturer includes in their PMS Plan a commitment to conducting annual surveys of 100 clinical users to gather feedback on device performance.
- The PMS Plan specifies utilizing a national implant registry to track the long-term integrity and failure rates of a prosthetic device.
- A software as a medical device (SaMD) manufacturer outlines quarterly reviews of publicly available app store data and cybersecurity incident reports as part of their proactive surveillance activities.
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.
Frequently asked questions
The primary purpose is to systematically monitor the safety and performance of a medical device once it is on the market, ensuring its continued compliance with regulatory requirements and identifying any emerging risks.
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Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
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Annual Report (PMA)
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
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Customer Notification Letter
Communication to users notifying them of a safety issue, corrective action, or important product information.
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Electronic Medical Device Reporting(eMDR)
FDA's mandatory electronic submission system for Medical Device Reports.
Cited by
Where this term appears across MedTech Terms.
Ecosystems (1)
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1FDA·2
- 1
MDR Annex IIIVerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
- 3
FDA Recalls - Medical DevicesVerifiedFDAfda.gov
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