The In Vitro Diagnostic Medical Devices Regulations 2000

Interpretation

2.—(1) In these Regulations, unless the context otherwise requires—

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

“the 1994 Regulations” means the Medical Devices Regulations 1994(1);

“the 1995 Regulations” means the Medical Devices Fees Regulations 1995(2);

“accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—

(a)

itself an in vitro diagnostic medical device;

(b)

an invasive sampling medical device; or

(c)

a medical device which is directly applied to the human body for the purpose of obtaining a specimen;

“authorised representative” means a person established within the Community who, explicitly designated by the manufacturer (in accordance with regulation 13 or otherwise), acts for the manufacturer and may be addressed by authorities and bodies in the Community instead of the manufacturer;

“calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;

“CE marking” means a conformity marking consisting of the initials “ CE”;

“common technical specification” means a technical specification for a relevant device referred to in a list in Annex II which has been adopted in accordance with the procedure set out in article 7(2) and published in the Official Journal of the European Communities;

“the Community” means the European Community;

“device for performance evaluation” means a product which is intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises;

“device for self-testing” means an in vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment;

“the Directive” means Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices(3);

“intended purpose” means the use for which a relevant device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials;

“in vitro diagnostic medical device” means a medical device which—

(a)

is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

(b)

is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—

(i)

concerning a physiological or pathological state,

(ii)

concerning a congenital abnormality,

(iii)

to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

(iv)

to monitor therapeutic measures,

and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination;

“manufacturer” means—

(a)

the person with responsibility 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; or

(b)

any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;

“medical device” has the same meaning as the meaning given for “ device” in the 1994 Regulations;

“notified body” means, in relation to any task, a body designated and notified in respect of that task in accordance with article 15 or under regulation 15;

“placing on the market” means, in relation to a relevant device, the first making available in return for payment or free of charge of a new or fully refurbished relevant device with a view to distribution, use, or both, on the Community market;

“putting into service” means, in relation to a relevant device, the first making available of the device in the Community to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;

“relevant device” shall be construed in accordance with regulation 3(1);

“relevant essential requirement” means, in relation to a relevant device, an essential requirement which, for the purposes of regulation 4, applies to it;

“relevant harmonised standard” means a technical specification adopted, on a mandate from the European Commission, by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or by both of those bodies, in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations(4), pursuant to the general guidelines on co-operation between the Commission and the said Committees signed on 13th November 1984;

“relevant national standard” means a standard transposing a relevant harmonised standard, the reference number of which has been published in the Official Journal of the European Communities;

“relevant notified body identification number” means, in relation to a relevant device, the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII relating to assessment of that device by a notified body, that number being the identification number assigned to the notified body by the European Commission in accordance with article 15(1);

“specimen receptacle” means a medical device which (whether vacuum-type or not) is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;

“supply”, in relation to a device, means the supply of, or offer or agreement to supply, the device, or the exposure or possession for supply of the device;

“UK notified body” shall be construed in accordance with regulation 15(1).

(2) In these Regulations, unless the context otherwise requires, a reference—

(a) to a numbered regulation is to the regulation of these Regulations bearing that number;

(b) in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter;

(c) in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter; and

(d) to a numbered article or Annex is to the article or Annex of the Directive bearing that number.

(1)

S.I. 1994/3017.

(2)

S.I. 1995/2487; amended by S.I. 1997/694.

(3)

O.J. No. L331, 7.12.1998, p. 1.

(4)

O.J. L204, 21.7.1998, p. 37; amended by Directive 98/48/EC (O.J. 217, 5.8.1998, p. 18).