--- title: "Post-Market Surveillance Plan, Definition | MedTech Terms" description: "Documented plan describing PMS activities, data sources, methods, and review frequency. Plain-English Post-Market definition for MedTech teams, with examples an" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pms-plan#term", "name": "Post-Market Surveillance Plan", "description": "MDR Annex III requires a PMS Plan covering proactive and reactive collection of clinical data, complaints, registries, literature, similar-device data, and trend analysis. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Post-Market Surveillance Plan [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety) # Post-Market Surveillance Plan Documented plan describing PMS activities, data sources, methods, and review frequency. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition [MDR](/terms/mdr-reporting) Annex III requires a [PMS](/terms/post-market-surveillance) Plan covering proactive and reactive collection of clinical data, complaints, registries, literature, similar-device data, and trend analysis. Drives PSURs, PMS Reports, and [PMCF](/terms/pmcf) Plans. What the regulation says The [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) 2017/745, specifically Article 84 and Annex III, mandates that manufacturers establish, document, implement, and maintain a [Post-Market Surveillance](/terms/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](/terms/post-market-surveillance) Plan is a recurring [Notified Body](/terms/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 What is the primary purpose of a PMS Plan? 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. How does the PMS Plan relate to risk management? Who is responsible for developing and maintaining the PMS Plan? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Post-Market Clinical Follow-up(PMCF) Proactive collection of clinical data on a CE-marked device to confirm safety and performance. ](/terms/pmcf) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Post-Market & Safety](/ecosystems/post-market-safety) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 FDA· 2 1. [1 MDR Annex III Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 2. [2 FDA MAUDE Database Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) 3. [3 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=pms-plan) Learn in 60 seconds Card Lesson Quiz Documented plan describing PMS activities, data sources, methods, and review frequency. - · A weak PMS Plan is a recurring Notified Body finding; reviewers want to see specific, measurable activities - not boilerplate. - · Drives PSURs, PMS Reports, and PMCF Plans. Remember this Watch out: A common pitfall is creating a generic PMS Plan that lacks specific, actionable tasks and measurable outcomes. Related terms - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) You may also need Auto-suggested from Post-Market and shared keywords. - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Trend Reporting (MDR/MIR) ](/terms/trend-reporting) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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