--- title: "GSPRs Definition & Meaning | MedTech Terms" description: "Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. Plain-English Regulatory definition for MedTech teams, with examples and rel" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/gspr#term", "name": "General Safety and Performance Requirements", "alternateName": "GSPRs", "description": "GSPRs replace the old Essential Requirements of MDD/IVDD. Manufacturers prepare a GSPR checklist mapping each requirement to the design output, harmonized standard, and documentary evidence demonstrating conformity.", "url": "https://medtechterms.com/terms/gspr", "termCode": "gspr", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/gspr#article", "headline": "GSPRs, General Safety and Performance Requirements", "description": "Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.", "url": "https://medtechterms.com/terms/gspr", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/gspr" }, "about": { "@id": "https://medtechterms.com/terms/gspr#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "General Safety and Performance Requirements, GSPRs, Regulatory, 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": "MDR Annex I", "url": "https://eur-lex.europa.eu/eli/reg/2017/745/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } }, { "@type": "CreativeWork", "name": "RAPS Regulatory Focus", "url": "https://www.raps.org/news-and-articles/news-articles", "publisher": { "@type": "Organization", "name": "RAPS" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr#term", "name": "EU Medical Device Regulation", "alternateName": "MDR", "url": "https://medtechterms.com/terms/mdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "url": "https://medtechterms.com/terms/ivdr" } ] }, { "@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": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "General Safety and Performance Requirements", "item": "https://medtechterms.com/terms/gspr" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/gspr#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of the GSPRs?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose of the GSPRs is to establish fundamental safety and performance benchmarks that medical devices and in vitro diagnostic devices must meet to protect patients, users, and other persons, while achieving their intended purpose." } }, { "@type": "Question", "name": "How do GSPRs relate to harmonized standards?", "acceptedAnswer": { "@type": "Answer", "text": "Harmonized standards provide a presumption of conformity with the GSPRs they cover, meaning that meeting the requirements of a relevant harmonized standard indicates compliance with the corresponding GSPRs. However, manufacturers can choose other solutions to demonstrate GSPR compliance, provided they are equally effective." } }, { "@type": "Question", "name": "Are GSPRs only relevant for new devices?", "acceptedAnswer": { "@type": "Answer", "text": "No, GSPRs apply to all devices subject to the EU MDR and IVDR, including legacy devices that transition under the new regulations, and require ongoing conformity throughout the device's lifecycle, necessitating post-market surveillance and vigilance activities." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. General Safety and Performance Requirements [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)GSPRs # General Safety and Performance Requirements Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition GSPRs replace the old Essential Requirements of MDD/IVDD. Manufacturers prepare a [GSPR](/terms/ivdr-gspr) checklist mapping each requirement to the design output, harmonized standard, and documentary evidence demonstrating conformity. What the regulation says Under the [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting) 2017/745) and In Vitro Diagnostic Regulation ( [IVDR](/terms/ivdr) 2017/746), manufacturers must demonstrate conformity with the General Safety and Performance Requirements ( [GSPR](/terms/ivdr-gspr)) set out in Annex I of each regulation. This demonstration is a prerequisite for CE marking and placing a device on the European market, as outlined in Article 48 of the MDR. Regulators expect manufacturers to compile and maintain technical documentation, including a GSPR checklist, to prove compliance throughout the device lifecycle. ## What this means in practice The [GSPR](/terms/ivdr-gspr) checklist is the [spine](/terms/spine) of the EU technical documentation and one of the first things a [Notified Body](/terms/notified-body) audits. ## Examples - A manufacturer of a new blood glucose meter must document how the device meets GSPR 12.2 on accuracy and GSPR 17.1 on software validation, providing specific test reports and risk analysis outputs. - For a surgical robot, compliance with GSPR 14.1 on human factors and GSPR 16.1 on cybersecurity must be detailed, including usability studies and penetration test reports. - An in vitro diagnostic test kit Common pitfalls - • A common pitfall is failing to provide specific, traceable evidence for each GSPR, relying instead on general statements of compliance. - • Manufacturers often struggle to adequately address cybersecurity and data protection GSPRs, which require specialized expertise and detailed documentation. - • Another mistake is treating the GSPR checklist as a one-time activity rather than a living document that is updated throughout the device's lifecycle. - • Failing to link GSPR compliance to risk management outputs can lead to gaps in addressing potential harms and vulnerabilities. - • Incorrectly interpreting the scope and intent of certain GSPRs can result in inadequate technical solutions and non-compliance discoveries during audits. ## Frequently asked questions What is the primary purpose of the GSPRs? The primary purpose of the GSPRs is to establish fundamental safety and performance benchmarks that medical devices and in vitro diagnostic devices must meet to protect patients, users, and other persons, while achieving their intended purpose. How do GSPRs relate to harmonized standards? Are GSPRs only relevant for new devices? ## 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 EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### IVDR Essentials · From this learning path [ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. Adjacent lesson ](/terms/notified-body?from=ivdr-essentials)[ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=ivdr-essentials)[ Clinical & Trials Clinical Evaluation Plan(CEP) EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER). Adjacent lesson ](/terms/clinical-evaluation-plan?from=ivdr-essentials)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed?from=ivdr-essentials) ### More in Regulatory · Same category [ Regulatory IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [IVDR Essentials](/paths/ivdr-essentials)Lesson 6 of 13 Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [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 MDR Annex I Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/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 Acronym GSPRs Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=gspr) Learn in 60 seconds Card Lesson Quiz Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. - · The GSPR checklist is the spine of the EU technical documentation and one of the first things a Notified Body audits. - · Manufacturers prepare a GSPR checklist mapping each requirement to the design output, harmonized standard, and documentary evidence demonstrating conformity. Remember this Watch out: A common pitfall is failing to provide specific, traceable evidence for each GSPR, relying instead on general statements of compliance. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) You may also need Auto-suggested from Regulatory and shared keywords. - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [CE Mark ](/terms/ce-mark) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) [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. 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)