--- title: "In-House IVDs (Article 5(5)), Definition | MedTech Terms" description: "Devices manufactured and used within a single EU health institution under conditions in IVDR Article 5(5). 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. In-House IVDs (Article 5(5)) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # 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 Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 5(5) exempts devices manufactured and used exclusively within health institutions established in the Union from most [IVDR](/terms/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. ## 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) ### 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: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 MDCG· 1 IMDRF· 1 1. [1 Regulation (EU) 2017/746, Article 5(5) Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 MDCG 2023-1 Article 5(5) Guidance Unchecked MDCG health.ec.europa.eu ](https://health.ec.europa.eu/latest-updates/mdcg-2023-1-guidance-health-institution-exemption-under-article-55-ivdr-2023-01-19_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. [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 Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-in-house-devices) Learn in 60 seconds Card Lesson Quiz Devices manufactured and used within a single EU health institution under conditions in IVDR Article 5(5). - · 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. Remember this Watch out: Assuming the exemption covers cross-institution networks. It applies to a single health institution. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) You may also need Auto-suggested from Regulatory and shared keywords. - [CE Mark ](/terms/ce-mark) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [Emergency Use Authorization(EUA) ](/terms/eua) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) [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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