Genetic Testing Requirements (IVDR Article 4)
Member-State-level obligations on information, counselling, and consent for genetic testing performed with IVDs.
Definition
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. Article 4 also allows Member States to adopt additional national rules including on informed consent and genetic counselling.What this means in practice
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.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
IVDR categories for devices intended for use by lay persons (self-test) or outside a laboratory environment by healthcare professionals (near-patient).
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Article 4VerifiedEUR-Lexeur-lex.europa.eu
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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