rec_29

(29) This Directive should not apply to healthcare as defined in Directive 2011/24/EU of the European Parliament and of the Council 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). . The exclusion of ‘healthcare’ from the scope of this Directive should also apply to any digital content or digital service that constitutes a medical device, as defined in Council Directive 93/42/EEC Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). or 90/385/EEC Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17). or Directive 98/79/EC of the European Parliament and of the Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). , where such medical device is prescribed or provided by a health professional as defined in Directive 2011/24/EU. However, this Directive should apply to any digital content or digital service that constitutes a medical device, such as health applications, that can be obtained by the consumer without being prescribed or provided by a health professional.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.