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2.  In these Regulations—

the Directive” means 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 F1;

[F2Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use;]

health care” means health services provided by health professionals to patients to assess, maintain or restore their state of health, and includes the prescription, dispensing and provision of medicinal products and medical devices;

health care provider” means a person providing health care;

health professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 F3 (the Professional Standards Authority for Health and Social Care);

medical device” means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of—


the diagnosis, prevention, monitoring, treatment or alleviation of disease;


the diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;


the investigation, replacement or modification of the anatomy or of a physiological process;


the control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

medicinal product” means any substance or combination of substances—


presented for treating or preventing disease in human beings; or


which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings;

the NCP” means the national contact point designated under regulation 3;

the NHS Act” means the National Health Service (Scotland) Act 1978 F4;

prescription” means a prescription for a medicinal product or for a medical device issued by a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC of the European Parliament and the Council of 7 September 2005 on the recognition of professional qualifications F5 who is legally entitled to do so in the member state in which the prescription is issued;

resident patient” means an individual ordinarily resident in Scotland for whom the United Kingdom is the member state of affiliation within the meaning of the Directive;

visiting patient” means an individual for whom a Member State other than the United Kingdom is the member state of affiliation within the meaning of article 3(c) of the Directive.

F1OJ L 88, 4.4.2011, p.45.

F32002 c.17. Section 25 has been amended by the Health and Social Care Act 2008 (c.14), section 113, Schedule 10, paragraph 17 and Schedule 15, Part 2; and by S.I. 2010/231 and further amended by the Health and Social Care Act 2012 (c.7), sections 220 to 224.

F5OJ L 255, 30.9.2005, p.22.

F61972 c.68. Section 2(2) was amended by the Scotland Act 1998 Act (c.46) (“the 1998 Act”), Schedule 8, paragraph 15(3), (which was amended by section 27(4) of the Legislative and Regulatory Reform Act 2006 (c.51) (“the 2006 Act”), section 2(2) was also amended by section 27(1)(a) of the 2006 Act and the European Union (Amendment) Act 2008 (c.7), section 3(3) and Schedule Part 1. The functions conferred upon the Minister of the Crown under section 2(2), insofar as within devolved competence, were transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act.