--- title: "Self-Test and Near-Patient Testing (IVDR)… | MedTech Terms" description: "IVDR categories for devices intended for use by lay persons (self-test) or outside a laboratory environment by healthcare professionals (near-patient)." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-self-test#term", "name": "Self-Test and Near-Patient Testing (IVDR)", "description": "Article 2(5) defines a device for self-testing as an IVD intended to be used by lay persons, including in home settings. Article 2(6) defines a device for near-patient testing as intended for testing performed outside a laboratory environment, generally near to or at the side of the patient, by a health professional. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Self-Test and Near-Patient Testing (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # Self-Test and Near-Patient Testing (IVDR) IVDR categories for devices intended for use by lay persons (self-test) or outside a laboratory environment by healthcare professionals (near-patient). Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 2(5) defines a device for self-testing as an [IVD](/terms/ivd) intended to be used by lay persons, including in home settings. Article 2(6) defines a device for near-patient testing as intended for testing performed outside a laboratory environment, generally near to or at the side of the patient, by a health professional. Classification rules and usability requirements differ, and Annex I Section 19 sets out specific information-for-use requirements. ## What this means in practice Self-test devices attract additional usability engineering scrutiny under [IEC 62366-1](/terms/iec-62366-1) and, in most cases, a higher risk class than the equivalent professional-use device. [Instructions for use](/terms/ifu) must be understandable by a lay person with the education level of the intended user. ## 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 Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes) ### 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 (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 European Commission· 1 IMDRF· 1 1. [1 Regulation (EU) 2017/746, Article 2 and Annex I Section 19 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) 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. 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On this term Category Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-self-test) Learn in 60 seconds Card Lesson Quiz IVDR categories for devices intended for use by lay persons (self-test) or outside a laboratory environment by healthcare professionals (near-patient). - · Self-test devices attract additional usability engineering scrutiny under IEC 62366-1 and, in most cases, a higher risk class than the equivalent professional-use device. - · Instructions for use must be understandable by a lay person with the education level of the intended user. - · Article 2(6) defines a device for near-patient testing as intended for testing performed outside a laboratory environment, generally near to or at the side of the patient, by a health professional. Remember this IVDR categories for devices intended for use by lay persons (self-test) or outside a laboratory environment by healthcare professionals (near-patient). Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) You may also need Auto-suggested from Regulatory and shared keywords. - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) [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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