--- title: "PSUR, Periodic Safety Update Report | MedTech Terms" description: "Periodic EU MDR/IVDR report summarizing post-market surveillance findings. Plain-English Post-Market definition for MedTech teams, with examples and related ter" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/psur#term", "name": "Periodic Safety Update Report", "alternateName": "PSUR", "description": "Per EU MDR Article 86, the PSUR summarizes results and conclusions of analyses of post-market surveillance data, including main findings of the PMCF, the rationale and description of preventive and corrective actions, and the volume of sales.", "url": "https://medtechterms.com/terms/psur", "termCode": "psur", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/psur#article", "headline": "PSUR, Periodic Safety Update Report", "description": "Periodic EU MDR/IVDR report summarizing post-market surveillance findings.", "url": "https://medtechterms.com/terms/psur", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/psur" }, "about": { "@id": "https://medtechterms.com/terms/psur#term" }, "articleSection": "Post-Market", "inLanguage": "en", "keywords": "Periodic Safety Update Report, PSUR, Post-Market, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "EU MDR Article 86", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "FDA MAUDE Database", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA Recalls - Medical Devices", "url": "https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/post-market-surveillance#term", "name": "Post-Market Surveillance", "alternateName": "PMS", "url": "https://medtechterms.com/terms/post-market-surveillance" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr#term", "name": "EU Medical Device Regulation", "alternateName": "MDR", "url": "https://medtechterms.com/terms/mdr" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Post-Market", "item": "https://medtechterms.com/terms?cat=Post-Market" }, { "@type": "ListItem", "position": 4, "name": "Periodic Safety Update Report", "item": "https://medtechterms.com/terms/psur" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/psur#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of a PSUR under EU MDR?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to systematically report on the safety and performance of a MedTech device post-market, drawing conclusions from gathered surveillance data to ensure ongoing compliance and patient safety." } }, { "@type": "Question", "name": "How does the PSUR relate to risk management?", "acceptedAnswer": { "@type": "Answer", "text": "The PSUR directly informs and is informed by the risk management process, as it presents data that can trigger updates to the risk-benefit assessment and necessitates new or modified risk control measures." } }, { "@type": "Question", "name": "Who is responsible for preparing and submitting the PSUR?", "acceptedAnswer": { "@type": "Answer", "text": "The manufacturer of the MedTech device is responsible for preparing and, where applicable, submitting the PSUR to the relevant Notified Body or competent authorities." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Periodic Safety Update Report [All terms](/terms) Post-Market [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)PSUR # Periodic Safety Update Report Periodic EU MDR/IVDR report summarizing post-market surveillance findings. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per EU [MDR](/terms/mdr-reporting) Article 86, the PSUR summarizes results and conclusions of analyses of [post-market surveillance](/terms/post-market-surveillance) data, including main findings of the [PMCF](/terms/pmcf), the rationale and description of preventive and corrective actions, and the volume of sales. What the regulation says The Periodic Safety Update Report (PSUR) is a key [post-market surveillance](/terms/post-market-surveillance) document required under the [EU Medical Device Regulation](/terms/mdr) (EU [MDR](/terms/mdr-reporting)) in Article 86. It provides a comprehensive summary of post-market surveillance data, including findings from [Post-Market Clinical Follow-up](/terms/pmcf) (PMCF) and the rationale for preventive and corrective actions. The frequency of PSUR submission is risk-based, with Class IIb implantable and Class III devices typically requiring annual reports that are subject to assessment by a [Notified Body](/terms/notified-body). ## What this means in practice PSUR frequency depends on device classification. Class IIb implantable and Class III devices require annual PSURs assessed by Notified Bodies. ## Examples - A manufacturer of a Class III orthopedic implant submits an annual PSUR detailing field safety corrective actions implemented due to a higher-than-expected revision rate identified through vigilance data. - A company developing a Class IIb active implantable device includes a section in their PSUR outlining the results of their PMCF study, demonstrating the long-term efficacy of the device in a larger patient population. - A MedTech firm Common pitfalls - • Failing to integrate findings from all post-market surveillance activities, such as PMCF, into the PSUR is a common mistake. - • Submitting a PSUR that lacks clear justification for chosen preventive and corrective actions can lead to regulatory non-compliance. - • Incorrectly determining the submission frequency of the PSUR based on device classification or regulatory updates is a frequent error. - • Omitting quantitative data, such as sales volumes, or qualitative insights that support the conclusions in the PSUR will lead to an incomplete report. - • Not adequately linking the PSUR content to an updated risk-benefit assessment of the device can be a significant oversight. ## Frequently asked questions What is the primary purpose of a PSUR under EU MDR? The primary purpose is to systematically report on the safety and performance of a MedTech device post-market, drawing conclusions from gathered surveillance data to ensure ongoing compliance and patient safety. How does the PSUR relate to risk management? Who is responsible for preparing and submitting the PSUR? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ EU Medical Device Regulation(MDR) ](/terms/mdr) ### Follows Comes after in a typical workflow or lifecycle. - [ Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### EU MDR Essentials · From this learning path [ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. Adjacent lesson ](/terms/vigilance?from=eu-mdr-essentials)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=eu-mdr-essentials)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. Adjacent lesson ](/terms/udi?from=eu-mdr-essentials)[ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=eu-mdr-essentials) ### Post-Market Mastery · From this learning path [ Post-Market Medical Device Recall Removal or correction of a marketed device that violates FDA law. ](/terms/recall?from=post-market-mastery)[ Post-Market Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. ](/terms/mdr-reporting?from=post-market-mastery)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=post-market-mastery)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa?from=post-market-mastery) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [EU MDR Essentials](/paths/eu-mdr-essentials)Lesson 7 of 9 - [Post-Market Mastery](/paths/post-market-mastery)Lesson 2 of 9 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 FDA· 2 1. [1 EU MDR Article 86 Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745) 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 Acronym PSUR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=psur) Learn in 60 seconds Card Lesson Quiz Periodic EU MDR/IVDR report summarizing post-market surveillance findings. - · PSUR frequency depends on device classification. - · Class IIb implantable and Class III devices require annual PSURs assessed by Notified Bodies. Remember this Watch out: Failing to integrate findings from all post-market surveillance activities, such as PMCF, into the PSUR is a common mistake. Related terms - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [EU Medical Device Regulation(MDR) ](/terms/mdr) You may also need Auto-suggested from Post-Market and shared keywords. - [PSUR (IVDR Specific) ](/terms/psur-ivdr) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Medical Device Vigilance ](/terms/vigilance) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) [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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)