The Medical Devices Regulations 1994

means an article which, whilst not being a device, is intended specifically by its manufacturer to be used together with a device to enable the device to be used as intended by its manufacturer;

means an Annex to the Directive, and a reference in these Regulations to a numbered Annex is to the Annex of the Directive which is so numbered;

means an authorised representative established within the Community;

means, in relation to a device— (a) that it is manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner or a professional user which gives, under his responsibility, specific characteristics as to its design;

means a medical device, that is to say an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which— (a) is intended by the manufacturer to be used for human beings for the purpose of— (a) diagnosis, prevention, monitoring, treatment or alleviation of disease, (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, (iii) investigation, replacement or modification of the anatomy or of a physiological process, or (iv) control of conception;

means the requirements specified in Annex I 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;

means— (a) 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 European Commission 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, Council Directive 90/320/EEC and European Parliament and Council Directive 94/10/EC, and the reference of which has been published in the Official Journal of the European Communities;

means, in relation to a device, that it is intended for use by a duly qualified medical practitioner or a professional user when conducting investigations of that device in an adequate human clinical environment;

means, in relation to a device, the use for which it is intended according to the data supplied by the manufacturer on the labelling, and— (a) the instructions;

means the person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party;

means a registered medical practitioner;

means devices which, whether or not the Secretary of State considers them unsafe, she considers to be devices to which the CE marking has been wrongly applied and to be devices—

means, in relation to any task, a body designated and notified in respect of that task in accordance with Article 16 of the Directive;

means, in relation to a device, the first making available in return for payment or free of charge of a new or fully refurbished device other than a device intended for clinical investigation, with a view to distribution, use, or both, on the Community market;

means, in relation to a device, making it ready for use on the Community market for the first time for its intended purpose;

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;

means the identification number of the notified body which was responsible for carrying out tasks of the notified body under Annex II, IV, V or VI as respects a procedure which has been followed by the manufacturer of a device;

means the supply, offer to supply, agreement to supply, exposure for supply or possession for supply.

means the Consumer Protection Act 1987;

means the European Economic Area established under the EEA Agreement but until that Agreement comes into force in relation to Liechtenstein does not include the State of Liechtenstein;

means Council Directive 84/539/EEC on the approximation of the laws of the member States relating to electro-medical equipment used in veterinary medicine;”

means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;

means, in relation to a device, that it is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination and that it is intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof,