--- title: "PSUR (IVDR Specific), Definition | MedTech Terms" description: "Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. Plain-English Post-Market definition for MedTech teams, with examples and related t" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/psur-ivdr#term", "name": "PSUR (IVDR Specific)", "description": "Class C and D IVDs require annual PSURs; Class B IVDs require PSURs at least every two years; Class A is exempt. 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Class A IVDs are exempt from PSUR requirements." } }, { "@type": "Question", "name": "What kind of data should be included in an IVDR PSUR?", "acceptedAnswer": { "@type": "Answer", "text": "An IVDR PSUR should include a summary of post-market surveillance data, a re-evaluation of the benefit-risk balance, information on sales volumes, and the status of any Post-Market Performance Follow-up (PMPF) activities." } }, { "@type": "Question", "name": "Who reviews the PSUR for high-risk IVDs?", "acceptedAnswer": { "@type": "Answer", "text": "For Class C and D IVDs, the PSURs are reviewed by a Notified Body as part of their ongoing oversight responsibilities." } } ] } ] } --- [ 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. PSUR (IVDR Specific) [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 (IVDR Specific) Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Class C and D IVDs require annual PSURs; Class B IVDs require PSURs at least every two years; Class A is exempt. PSURs summarize [PMS](/terms/post-market-surveillance) data, benefit-risk re-evaluation, sales volumes, and [PMPF](/terms/ivdr-pmpf) status. What the regulation says The EU [IVDR](/terms/ivdr) (Regulation (EU) 2017/746) mandates the preparation of A [Periodic Safety Update Report](/terms/psur) (PSUR) as a [post-market surveillance](/terms/post-market-surveillance) document for certain classes of in vitro diagnostic ( [IVD](/terms/ivd)) devices. Specifically, Article 81 outlines the requirements for PSURs, detailing their content and submission frequency to Notified Bodies, where applicable. The PSUR serves to update the competent authorities on the post-market performance and safety of an IVD throughout its lifecycle. ## What this means in practice Closely linked to the Summary of Safety and Performance ( [SSP](/terms/ivdr-summary-safety-performance)) for high-risk IVDs and reviewed by Notified Bodies for Class C/D devices. ## Examples - A manufacturer of a Class C IVD for cancer biomarkers submits its annual PSUR to its Notified Body, detailing post-market complaints, vigilance cases, sales data, and the status of its PMPF plan. - An IVD company developing a Class B diagnostic for infectious diseases prepares a PSUR every two years, summarizing data from user feedback, literature reviews, and an updated benefit-risk assessment. - A manufacturer of a Class D IVD used for blood screening updates its PSUR with new clinical evidence and a re-analysis of adverse event trends observed in the field. Common pitfalls - • Confusing the PSUR frequency requirements between IVD classes can lead to non-compliance. - • Failing to include a comprehensive benefit-risk re-evaluation in the PSUR is a common deficiency. - • Inadequate data collection for post-market surveillance (PMS) will result in an incomplete PSUR. - • Omitting the PMPF (Post-Market Performance Follow-up) status update renders the PSUR deficient. - • Assuming Class A devices never require any form of post-market surveillance reporting is incorrect, even if a PSUR is not mandated. ## Frequently asked questions What is the primary purpose of an IVDR PSUR? The primary purpose of an [IVDR](/terms/ivdr) [PSUR](/terms/psur) is to report on the post-market safety and performance of an [IVD](/terms/ivd), including any changes to its benefit-risk profile, and to confirm its continued compliance with the regulation. Which IVD classes require a PSUR under the IVDR? What kind of data should be included in an IVDR PSUR? Who reviews the PSUR for high-risk IVDs? ## 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)[ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur) ### IVDR Essentials · From this learning path [ Post-Market Post-Market Performance Follow-up(PMPF) The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification. Adjacent lesson ](/terms/pmpf?from=ivdr-essentials)[ Regulatory EUDAMED European Database on Medical Devices. Adjacent lesson ](/terms/eudamed?from=ivdr-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=ivdr-essentials)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance?from=ivdr-essentials) ### 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) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [IVDR Essentials](/paths/ivdr-essentials)Lesson 9 of 13 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 IVDR Article 81 Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/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=psur-ivdr) Learn in 60 seconds Card Lesson Quiz Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. - · Closely linked to the Summary of Safety and Performance (SSP) for high-risk IVDs and reviewed by Notified Bodies for Class C/D devices. - · PSURs summarize PMS data, benefit-risk re-evaluation, sales volumes, and PMPF status. Remember this Watch out: Confusing the PSUR frequency requirements between IVD classes can lead to non-compliance. Related terms - [Periodic Safety Update Report(PSUR) ](/terms/psur) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) You may also need Auto-suggested from Post-Market and shared keywords. - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Annual Report (PMA) ](/terms/annual-report-pma) - [Medical Device Vigilance ](/terms/vigilance) [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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