All terms
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 CyberLast reviewed July 25, 2026
Definition
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. 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 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.Related terms
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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.
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.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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Ecosystems (2)
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1European Commission·1IMDRF·1
- 1
Regulation (EU) 2017/746, Article 2 and Annex I Section 19VerifiedEUR-Lexeur-lex.europa.eu
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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