--- title: "GSPR Definition & Meaning | MedTech Terms" description: "Annex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-gspr#term", "name": "General Safety and Performance Requirements (IVDR)", "alternateName": "GSPR", "description": "Annex I sets out three chapters of General Safety and Performance Requirements. Chapter I covers general requirements including risk management (Section 3) and benefit-risk determination (Section 8). Chapter II covers requirements regarding performance, design, and manufacture (Sections 9 to 19), including analytical performance, clinical performance, chemical/physical/biological properties, sterility, protection against radiation, software, and devices with a measuring function. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. General Safety and Performance Requirements (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)GSPR # General Safety and Performance Requirements (IVDR) Annex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Annex I sets out three chapters of [General Safety and Performance Requirements](/terms/gspr). Chapter I covers general requirements including risk management (Section 3) and [benefit-risk determination](/terms/benefit-risk) (Section 8). Chapter II covers requirements regarding performance, design, and manufacture (Sections 9 to 19), including analytical performance, clinical performance, chemical/physical/biological properties, sterility, protection against radiation, software, and devices with a measuring function. Chapter III covers requirements regarding the information supplied with the device (Section 20), including labelling and [instructions for use](/terms/ifu). What the regulation says Article 5(2) states that a device shall meet the [general safety and performance requirements](/terms/gspr) set out in Annex I which apply to it, taking into account its intended purpose. ## What this means in practice The [IVDR](/terms/ivdr) GSPR replaces the Essential Requirements of the old IVDD Annex I. Manufacturers demonstrate GSPR conformity through a GSPR checklist mapping each requirement to standards, [common specifications](/terms/common-specifications), and internal evidence. Notified bodies review this checklist as part of technical documentation assessment. ## 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 IVDR Performance Evaluation Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56. ](/terms/ivdr-performance-evaluation)[ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971) ### 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 (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 FDA· 1 European Commission· 1 1. [1 Regulation (EU) 2017/746, Annex I Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 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 GSPR Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-gspr) Learn in 60 seconds Card Lesson Quiz Annex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class. - · The IVDR GSPR replaces the Essential Requirements of the old IVDD Annex I. - · Manufacturers demonstrate GSPR conformity through a GSPR checklist mapping each requirement to standards, common specifications, and internal evidence. - · Notified bodies review this checklist as part of technical documentation assessment. Remember this Article 5(2) states that a device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [ISO 14971 ](/terms/iso-14971) You may also need Auto-suggested from Regulatory and shared keywords. - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [CE Mark ](/terms/ce-mark) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [Analytical Performance (IVDR) ](/terms/ivdr-analytical-performance) [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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