What is a common compliance mistake for manufacturers launching predisposition tests across the EU?

A common mistake is treating Article 4 compliance as satisfied by a single EU-wide patient information leaflet, when in practice manufacturers must map country-by-country genetic counselling and consent requirements before launching direct-to-consumer or clinical channels in each Member State. National rules can require professional genetic counselling that goes well beyond the Article 4 baseline.

Who is responsible for ensuring the Article 4 information is actually delivered to the patient?

Article 4(1) places the obligation on Member States to ensure the tested person receives the relevant information, which in practice is typically operationalised through the healthcare provider or testing laboratory ordering the test, working from information the manufacturer supplies in labelling and instructions for use. Manufacturers should ensure their materials give healthcare providers what they need to meet this national-level obligation.

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Genetic Testing Requirements (IVDR Article 4)

Q: What kind of genetic tests fall under Article 4's information obligation?

Article 4 applies 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, which covers tests such as BRCA, APOE, and pharmacogenomic panels. It applies regardless of the device's IVDR risk classification.

Member-State-level obligations on information, counselling, and consent for genetic testing performed with IVDs.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

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 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 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.

Examples

A clinic offering BRCA predisposition testing provides the person tested with relevant information about the test's nature, significance, and implications. Before introducing the service, it checks national requirements for informed consent and genetic counselling.
A hospital offering testing for predisposition to a condition generally considered untreatable ensures appropriate access to counselling. Its testing pathway also includes relevant information for the person tested or their legal representative.
A manufacturer planning clinical and direct-to-consumer channels for a predisposition test maps applicable requirements in each target country. It checks whether national rules affect consent, counselling, or the proposed delivery model rather than assuming CE marking permits an identical launch everywhere.

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.

Frequently asked questions

No, and this is an important distinction from most other IVDR provisions. Article 4 sets a baseline obligation that persons tested receive relevant information on the nature, significance, and implications of a genetic test, but it explicitly allows Member States to adopt additional national rules on informed consent and genetic counselling, producing meaningful fragmentation across the EU.

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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

Watch out: 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.

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