All terms
In-House IVDs (Article 5(5))
Devices manufactured and used within a single EU health institution under conditions in IVDR Article 5(5).
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
Definition
Article 5(5) exempts devices manufactured and used exclusively within health institutions established in the Union from most IVDR requirements, provided conditions are met: an appropriate quality management system, justification that patient needs cannot be met by an equivalent CE-marked device, documentation on manufacturing and performance, and public declaration and reporting to the competent authority.What this means in practice
In-house diagnostics (also known as laboratory-developed tests or LDTs in EU practice) are a major route for niche and rapidly evolving assays. Transition provisions extended key Article 5(5) documentation deadlines to 2028 and 2030 for high-risk classes, but the basic conditions apply now. Common pitfalls
- •Assuming the exemption covers cross-institution networks. It applies to a single health institution.
- •Overlooking the requirement to justify that no equivalent CE-marked device meets the need.
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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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Where this term appears across MedTech Terms.
Ecosystems (2)
Primary references
3 sourcesLink health: 2 verified 1 unchecked· last checked 2026-06-20
EUR-Lex·1MDCG·1IMDRF·1
- 1
Regulation (EU) 2017/746, Article 5(5)VerifiedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2023-1 Article 5(5) GuidanceUncheckedMDCGhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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