# The Active Implantable Medical Devices Regulations 1992, Regulation 2: Interpretation


(1) In these Regulations, unless the context requires otherwise—
“the 1987 Act” means the Consumer Protection Act 1987;
“authorised representative” means an authorised representative established within the European Economic Community;
“custom—made” means, in relation to a device,
(a) that it is manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific charac teristics as to its design, and
(b) that it is intended to be used only for a particular patient;
“device” means an active implantable medical device, that is to say an instrument, apparatus, appliance, material or other article, whether used alone or in combina tion, together with any accessories or software necessary for its proper functioning, which—
(a) is intended by the manufacturer to be used for human beings—
(i) in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
(ii) in the investigation, replacement or modification of the anatomy or of a physiological process, or
(iii) in the control of conception;
(b) does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, even if it is assisted in its function by such means;
(c) relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and
(d) is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced;
even if it is intended to administer a medicinal product as defined in the Medicines Act 1968 or incorporates as an integral part a substance which, if used separately, would be a medicinal product as so defined;
“the Directive” means Council Directive 90/385/EEC on the approximation of the laws of member States relating to active implantable medical devices;
“EC mark” means the mark which indicates that one or more of the procedures referred to in regulation 5 has been followed and which consists of a symbol comprising the letters “CE” of which an illustration is given in Schedule 1;
“essential requirements” means the requirements specified in Schedule 2 and “relevant essential requirements” in relation to a device means such of those requirements, or such aspects of those requirements, as apply to it, not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;
“harmonised Standard” means a technical specification adopted by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or both of them, upon a remit from the Commission of the European Economic Community pursuant to Council Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Council Directive 88/182/EEC and Council Directive 90/320/EEC, and the reference of which has been published in the Official Journal of the European Communities;
“intended for clinical investigation” means, in relation to a device, that it is intended for use by a medical specialist when conducting clinical investigations of that device;
“intended purpose” means, in relation to a device, the use for which it is intended and for which it is suited according to the data supplied by the manufacturer in the instructions relating to it;
“medical specialist” means a registered medical practitioner who has a qualification as, or is undergoing training intended to lead to qualification as, a specialist;
“member State” means a member State of the European Economic Community;
“notified body” means, in relation to any task, a body designated and notified in respect of that task in accordance with Article 11 of the Directive;
“placed on the market” means, in relation to a device, first supplied or first made available for supply in the United Kingdom otherwise than for the purpose of its export—
(a) to another country which is not a member State, and
(b) for use in a country that is not a member State;
“put into service” means make available to registered medical practitioners for implantation;
“relevant national Standard” means, in relation to an essential requirement or an aspect of it, a Standard—
(a) which contains a technical specification or a description relating to that requirement or aspect,
(b) which corresponds to a harmonised Standard containing such a specification or description, and
(c) of which the reference number is published in the United Kingdom by the Secretary of State by notice in the London, Edinburgh and Belfast Gazettes or in another member State of the European Economic Community;
“relevant notified body logo” means the logo of the notified body which was responsible for carrying out tasks of the notified body under paragraph 5 of Annex 2 to, under Annex 4 to, or under paragraph 4 of Annex 5 to, the Directive as respects a procedure which has been followed by the manufacturer of a device, and, where there is more than one such notified body, means the logo of each of them.
(2) In these Regulations, unless the context requires otherwise, a reference to a numbered regulation is a reference to the regulation of these Regulations which is so numbered; a reference in a regulation of, or Schedule to, these Regulations to a numbered paragraph is a reference to the paragraph of that regulation or Schedule which is so numbered, and a reference in a paragraph to a numbered sub—paragraph is a reference to the sub—paragraph of that paragraph which is so numbered.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/regulation/2 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.