Legalize / United Kingdom / Statutory-Instrument

The Medical Devices Regulations 2002

Type Statutory-Instrument

Publication 2002-05-20

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

Reform history JSON API PDF

Made: 20th May 2002

Laid before Parliament: 21st May 2002

Coming into force: 13th June 2002

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to medical devices, in exercise of the powers conferred by the said section 2(2), in exercise, with the consent of the Treasury, of the powers conferred by section 56(1) and (2) of the Finance Act 1973, in exercise of the powers conferred by sections 11 and 27(2) of the Consumer Protection Act 1987, and in exercise of all other powers enabling him in that behalf, after consultation in accordance with section 11(5) of the Consumer Protection Act 1987 with organisations appearing to him to be representative of interests substantially affected by these Regulations, with such other persons considered by him appropriate and with the Health and Safety Commission, hereby makes the following Regulations:—

PART I — Introductory Provisions Relating to all Medical Devices

Citation and commencement

1

These Regulations may be cited as the Medical Devices Regulations 2002 and shall come into force 13th June 2002.

Interpretation

2

(1) ... In these Regulations ...—

“active implantable medical device” means a medical device which—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; andis 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 or incorporates as an integral part a substance which, if used separately, would be a medicinal product;

“approved body” is to be construed in accordance with regulation A45;

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

“clinical data” means the safety or performance information that is generated from the use of a device, derived from—clinical investigations of the device concerned; orclinical investigations or other studies reported in scientific literature of a similar device for which equivalence to the device in question can be demonstrated; orpublished or unpublished reports on other clinical experiences of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

“coronavirus test device” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

“designated standard” has the meaning given in regulation 3A;

“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 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices as it had effect immediately before IP completion day;

“Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as it had effect immediately before IP completion day;

“Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices as it had effect immediately before IP completion day;

“Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;

“Directive 2005/50” means Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices;

“Directive 2007/47” means Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market;

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

“hazard” means a potential source of injury or damage to health;

“hip, knee or shoulder replacement” means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint, other than ancillary components (screws, wedges, plates and instruments);

“intended for clinical investigation” means— intended for use by a registered medical practitioner when conducting investigations of that device in an adequate human clinical environment; orintended for use by any other person in Great Britain who, by virtue of their professional qualification, is authorised to carry out investigations of that device in an adequate human clinical environment;

“intended purpose” means—in relation to an active implantable medical 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;in relation to any other medical device, the use to which the 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—is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; andis intended by the manufacturer to be usedin 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—concerning a physiological or pathological state,concerning a congenital abnormality,to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, orto 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 forin vitro diagnostic examination;

“machinery” has the meaning given to it by regulation 4 of the Supply of Machinery (Safety) Regulations 2008;

“manufacturer” means—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; orany 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” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—is intended by the manufacturer to be used for human beings for the purpose of-diagnosis, prevention, monitoring, treatment or alleviation of disease,diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,investigation, replacement or modification of the anatomy or of a physiological process, orcontrol of conception; anddoes 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,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, both read with Regulation (EU) No 207/2012 and Regulation (EU) No 722/2012 and Directive 98/79;

“medicinal product” has the meaning given in regulation 2(1) of the Human Medicines Regulations 2012;

“mutual recognition agreement” means an agreement that—is between the United Kingdom and a country listed in Schedule 2, andcovers matters including the conditions under which the United Kingdom and that country will accept or recognise the results of conformity assessment procedures undertaken by the each other's designated bodies;

“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 Great Britain market and related expressions must be construed accordingly;

“putting into service” means—in relation to an active implantable medical device, the making available of the device to a registered medical practitioner for implantation;in relation to any other medical device, the first making available of the device in Great Britain to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;

“Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices;(as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act)

“Regulation (EU) No 722/2012”— in Part 4A, has the meaning given in regulation 44ZC;in all other Parts means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (as retained under section 3 of the European Union (Withdrawal) Act 2018 and modified under section 8 of that Act);

“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;

“Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;

“Regulation (EU) 2022/1107” means Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council;

“relevant essential requirements”—in Part 4A, has the meaning given in regulation 44ZC;in all other Parts, 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 ofin 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—if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of regulation 2(2) of the Human Medicines Regulations 2012; andis liable to act upon the human body with action ancillary to that of the device;

“statistical review” means a review of the statistical sections of the written notice which a manufacturer or their UK responsible person submits to the Secretary of State pursuant to regulation 16(1) or 29(1) in respect of an intended clinical investigation of a relevant device;

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

“third country conformity assessment body” means a body established in a country which is listed in Schedule 2 and designated in accordance with a relevant mutual recognition agreement to carry out conformity assessment procedures for the purposes of these Regulations;

“UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008;

“UK responsible person” means a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations; and

“working day” means any day which is not Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday in any part of Great Britain under the Banking and Financial Dealings Act 1971.

(1A) In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A.

(1B) In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.

(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.

Scope of these Regulations

3

These Regulations shall not apply to—

(a) medicinal products governed by the Human Medicines Regulations 2012 (including medicinal products derived from human blood or human plasma ...);

(b) human blood, human blood products, plasma or blood cells of human origin;

(c) devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for —

(i) stable derivatives devices,

(ii) active implantable medical devices and accessories to such devices, and

(iii) in vitro diagnostic medical devices and accessories to such devices,;

(d) transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin , except for ..., in vitro diagnostic medical devices and accessories to such devices save where medicinal products are incorporated as ancillary to the device;

(e) transplants or tissues or cells of animal origin, unless—

(i) a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

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