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Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
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Article 4Genetic information, counselling and informed consent
1.Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as defined in point (a) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council(1) and for the medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance and the implications of the genetic test, as appropriate.
2.In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that there is appropriate access to counselling in the case of the use of genetic tests that provide information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable according to the state of science and technology.
3.Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease which the individual being tested is already known to have is confirmed by a genetic test or in cases where a companion diagnostic is used.
4.Nothing in this Article shall prevent Member States from adopting or maintaining measures at national level which are more protective of patients, more specific or which deal with informed consent.
(1)
Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
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