--- title: "Genetic Testing Requirements (IVDR Article … | MedTech Terms" description: "Member-State-level obligations on information, counselling, and consent for genetic testing performed with IVDs." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-genetic-testing#term", "name": "Genetic Testing Requirements (IVDR Article 4)", "description": "Article 4 of the IVDR requires that, where a genetic test is used on individuals in the context of medical care and provides information about a predisposition to a medical condition or disease, the person tested (or their legal representative) receives relevant information on the nature, significance, and implications of the test. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Genetic Testing Requirements (IVDR Article 4) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # Genetic Testing Requirements (IVDR Article 4) Member-State-level obligations on information, counselling, and consent for genetic testing performed with IVDs. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 4 of the [IVDR](/terms/ivdr) requires that, where a genetic test is used on individuals in the context of medical care and provides information about a predisposition to a medical condition or disease, the person tested (or their legal representative) receives relevant information on the nature, significance, and implications of the test. Article 4 also allows Member States to adopt additional national rules including on [informed consent](/terms/informed-consent) and genetic counselling. What the regulation says Article 4(1) states that Member States shall ensure that where a genetic test is used on individuals, the person being tested is provided with relevant information on the nature, significance and implications of the genetic test, as appropriate. ## What this means in practice Article 4 is one of the few [IVDR](/terms/ivdr) provisions that operates at the Member State rather than Union level, producing meaningful fragmentation. Manufacturers of predisposition tests (BRCA, APOE, pharmacogenomics) must map country-by-country requirements before launching direct-to-consumer or clinical channels. ## 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 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). ](/terms/ivdr-self-test) ### 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 IMDRF· 1 RAPS· 1 1. [1 Regulation (EU) 2017/746, Article 4 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS raps.org ](https://www.raps.org/news-and-articles/news-articles) 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-genetic-testing) Learn in 60 seconds Card Lesson Quiz Member-State-level obligations on information, counselling, and consent for genetic testing performed with IVDs. - · Article 4 is one of the few IVDR provisions that operates at the Member State rather than Union level, producing meaningful fragmentation. - · Manufacturers of predisposition tests (BRCA, APOE, pharmacogenomics) must map country-by-country requirements before launching direct-to-consumer or clinical channels. - · Article 4 also allows Member States to adopt additional national rules including on informed consent and genetic counselling. Remember this Article 4(1) states that Member States shall ensure that where a genetic test is used on individuals, the person being tested is provided with relevant information on the nature, significance and implications of the genetic test, as appropriate. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Self-Test and Near-Patient Testing (IVDR) ](/terms/ivdr-self-test) You may also need Auto-suggested from Regulatory and shared keywords. - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) [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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