The Medical Devices Regulations 2002

Interpretation

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

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

“active implantable medical device” means a medical device which—

even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product;

“Association Agreement” means an Agreement, listed in Schedule 1, establishing an Association between the European Communities and their Member States, on the one part, and another State on the other part (referred to in these Regulations as a “State which is a Party to an Association Agreement”) on Conformity Assessment and Acceptance of Industrial Products;

“authorised representative” means a person established within the Community or in a State which is a Party to an Association Agreement who, explicitly designated by the manufacturer, acts for the manufacturer and may be addressed by authorities and bodies in the Community instead of the manufacturer;

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

“the Community” means—

“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;

“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(1), as amended(2);

“Directive 93/42” means Council Directive 93/42/EEC of 14th June 1993 concerning medical devices(3), as amended(4);

“Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices(5);

“Directive 2001/83” 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(6);

“EC CAB” shall be construed in accordance with regulation 48(1);

“EEA State” means a State which is a Contracting Party to the EEA Agreement;

“European Economic Area” means the European Economic Area created by the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(7), as adjusted by the Protocol signed at Brussels on 17th March 1993(8) (“the EEA Agreement”);

“harmonised standard” means—

the reference number of which has been published in the Official Journal of the European Communities;

“intended for clinical investigation” means—

“intended purpose” means—

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

“manufacturer” means—

“medical device” means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which—

and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

“the Medical Devices Directives” means Directive 90/385, Directive 93/42 and Directive 98/79;

“medical specialist” means a registered medical practitioner who has a qualification as, or is undergoing training intended to lead to qualification as, a specialist;

“medicinal product” has the meaning given in article 1.2 of Directive 2001/83;

“Mutual Recognition Agreements” means the agreements, listed in Schedule 2, concluded between the European Community and States which are not part of the European Community on matters including the conditions under which each Party will accept or recognise the results of the conformity assessment procedures undertaken by the other Party’s designated bodies;

“national standard” means a technical specification adopted by a Member State of the Community which transposes, and corresponds to, a harmonised standard;

“notified body” means a body authorised in accordance with Part V of the Medical Devices Directives to carry out tasks of a notified body or the importing Party under the Medical Devices Directives or the Mutual Recognition Agreements in respect of a conformity assessment procedure;

“placing on the market” means, in relation to a medical 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—

“relevant essential requirements”, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but 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;

“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;

“stable derivatives device” means a medical device that contains human blood, blood products, plasma or blood cells of human origin, and which incorporates, as an integral part, a substance which—

“supply”, in relation to a medical device, means—

“third country conformity assessment body” means a body in a State which is not part of the European Community that is designated in accordance with the Mutual Recognition Agreements to carry out tasks of a notified body under the conformity assessment procedures set out in the Medical Devices Directives; and

“UK notified body” shall be construed in accordance with regulation 45.

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

(a)to a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, 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; and

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