--- title: "Post-Market Surveillance Plan (IVDR)… | MedTech Terms" description: "Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-pms-plan#term", "name": "Post-Market Surveillance Plan (IVDR)", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Post-Market Surveillance Plan (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle) # Post-Market Surveillance Plan (IVDR) Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 79 and Annex III of the [IVDR](/terms/ivdr) require every manufacturer to plan, establish, document, implement, maintain, and update a [post-market surveillance](/terms/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](/terms/ivdr-pmpf), literature, registries), the indicators and thresholds, and the linkage back into risk management and the performance evaluation. What the regulation says Annex III Section 1.1 specifies the required content of the [PMS](/terms/post-market-surveillance) Plan including proactive and reactive collection of data, methods for evaluating collected data, tools to trace and identify devices, and the effective communication with authorities and users. ## What this means in practice For Class A and B devices the outputs feed a [PMS](/terms/post-market-surveillance) Report (Article 80); for Class C and D they feed a [Periodic Safety Update Report](/terms/psur) (PSUR, Article 81) that is reviewed by the [notified body](/terms/notified-body) for Class C and D and, for Class D, made available through [EUDAMED](/terms/eudamed). ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory Post-Market Performance Follow-Up (IVDR)(PMPF) Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF. ](/terms/ivdr-pmpf)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance)[ Post-Market PSUR (IVDR Specific) Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. ](/terms/psur-ivdr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (4) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 IMDRF· 1 RAPS· 1 1. [1 Regulation (EU) 2017/746, Article 79 and Annex III Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [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 Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-pms-plan) Learn in 60 seconds Card Lesson Quiz Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market. - · 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. Remember this Annex III Section 1. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [PSUR (IVDR Specific) ](/terms/psur-ivdr) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) You may also need Auto-suggested from Regulatory and shared keywords. - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Surveillance Plan ](/terms/pms-plan) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.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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