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.

Why it matters

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.

Common pitfalls

•Assuming CE marking settles all requirements for offering a genetic test. Article 4 obligations and additional national rules must also be considered for the intended country and care pathway.
•Treating information provision, informed consent, and genetic counselling as interchangeable. Providing information about a test does not automatically satisfy applicable national consent or counselling requirements.
•Assuming every genetic test triggers the same counselling obligation. Article 4 specifically requires appropriate access to counselling for tests indicating predisposition to conditions generally considered untreatable, while Member States may impose broader protections.

Sources

Regulation (EU) 2017/746, Article 4 · EUR-Lex
IMDRF Documents · IMDRF
RAPS Regulatory Focus · RAPS

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