Regulation 2 Interpretation

In these Regulations, unless the context requires otherwise—

• “the 1987 Act” means the Consumer Protection Act 1987;

• “accessory” 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;

• “Annex” 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;

• “authorised representative” means an authorised representative established within the Community;

• “CE marking” means the marking which indicates that one or more of the procedures referred to in regulations 7, 8, 9, 10 and 11 has, or, as the case may be, have been followed and which consists of a symbol comprising the letters “CE” the form and dimensions of which are as specificed in Annex XII;

• “the Community” 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;

• “custom-made” means, in relation to a device—

  1. (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; and

  2. (b)

     that it is intended for the sole use of a particular patient,

  but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;

• “device” 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—

  1. (a)

     is intended by the manufacturer to be used for human beings for the purpose of—

     1. (i)

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

     2. (ii)

        diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

     3. (iii)

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

     4. (iv)

        control of conception; and

  2. (b)

     does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

  even if it is intended to administer a medicinal product as defined in Council Directive 65/65/EEC^f1 or incorporates as an integral part a substance which, if used separately, would be a medicinal product as so defined and which is liable to act upon the body with action ancillary to that of the device;

• “the Directive” means Council Directive 93/42/EEC concerning medical devices^f2;

• “the EEA Agreement” 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^f3;

• “EEA State” means a State which is a Contracting Party to the EEA Agreement but until the EEA Agreement comes into force in relation to Liechtenstein does not include the State of Liechtenstein;

• “essential requirements” 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;

• “harmonised Standard” means—

  1. (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^f4 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^f5, Council Directive 90/320/EEC^f6 and European Parliament and Council Directive 94/10/EC^f7, and the reference of which has been published in the Official Journal of the European Communities; or

  2. (b)

     a monograph of the European Pharmacopoeia and in particular any monograph on surgical sutures or on interaction between medicinal products and materials used in devices containing medicinal products, 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 duly qualified medical practitioner or a professional user when conducting investigations of that device in an adequate human clinical environment;

• “intended purpose” 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—

  1. (a)

     the instructions;

  2. (b)

     the promotional materials; or

  3. (c)

     the instructions and the promotional materials;

• “manufacturer” 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;

• “medical practitioner” means a registered medical practitioner;

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

• “placing on the market” 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;

• “putting into service” means, in relation to a device, making it ready for use on the Community market for the first time for its intended purpose;

• “relevant national Standard” means, in relation to an essential requirement or an aspect of it, a Standard—

  1. (a)

     which contains a technical specification or a description relating to that requirement or aspect;

  2. (b)

     which corresponds to a harmonised Standard containing such a specification or description; and

  3. (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;

• “relevant notified body identification number” 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;

• “used for in vitro diagnosis” 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,

In these Regulations, unless the context requires otherwise, a reference to a numbered regulation is to the regulation of these Regulations which is so numbered, a reference in a regulation to a numbered paragraph is to the paragraph of that regulation which is so numbered, and a reference in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph of that paragraph which is so numbered or lettered.