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The Medical Devices Regulations 2002 - Legislation.gov.uk

Changes to legislation: The Medical Devices Regulations 2002 is up to date with all changes known to be in force on orbefore 31 March 2022. There are changes that may be brought into force at a future date. Changes that have been madeappear in the content and are referenced with annotations. (See end of Document for details) View outstanding changesSTATUTORY INSTRUMENTS2002 No. 618 CONSUMER PROTECTIONThe Medical Devices Regulations 2002 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 EuropeanCommunities Act 1972F1 in relation to measures relating to Medical devicesF2, in exercise of thepowers conferred by the said section

as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use];

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Transcription of The Medical Devices Regulations 2002 - Legislation.gov.uk

1 Changes to legislation: The Medical Devices Regulations 2002 is up to date with all changes known to be in force on orbefore 31 March 2022. There are changes that may be brought into force at a future date. Changes that have been madeappear in the content and are referenced with annotations. (See end of Document for details) View outstanding changesSTATUTORY INSTRUMENTS2002 No. 618 CONSUMER PROTECTIONThe Medical Devices Regulations 2002 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 EuropeanCommunities Act 1972F1 in relation to measures relating to Medical devicesF2, in exercise of thepowers conferred by the said section 2(2), in exercise, with the consent of the Treasury, of thepowers conferred by section 56(1) and (2)

2 Of the Finance Act 1973F3, in exercise of the powersconferred by sections 11 and 27(2) of the Consumer Protection Act 1987F4, and in exercise of allother powers enabling him in that behalf, after consultation in accordance with section 11(5) of theConsumer Protection Act 1987 with organisations appearing to him to be representative of interestssubstantially affected by these Regulations , with such other persons considered by him appropriateand with the Health and Safety Commission, hereby makes the following Regulations : F11972 c. Secretary of State was designated in relation to measures relating to active implantable medicaldevices in 1991/2289, and in relation to measures relating to Medical Devices other than activeimplantable Medical Devices in 1993 c.

3 C. etc. (not altering text)C1 Regulations : power to amend conferred ( ) by Medicines and Medical Devices Act 2021(c. 3), ss. 15(1), 50(1)(f)PART IIntroductory Provisions Relating to all Medical DevicesCitation and Regulations may be cited as the Medical Devices Regulations 2002 and shall come intoforce 13th June Generated: 2022-03-31 Changes to legislation: The Medical Devices Regulations 2002 is up to date with all changes known to be in force on orbefore 31 March 2022. There are changes that may be brought into force at a future date.

4 Changes that have been madeappear in the content and are referenced with annotations. (See end of Document for details) View outstanding changes[F5 Expiry of certain provisions in these 19B, 19C, 30A, 44ZA and 44ZB cease to have effect at 23:59 on 30th 1ZA, 1A inserted ( ) ( ) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 ( 2019/791), regs. 1(1), 3(2) (as amended by 2020/1478, reg. 1(3), Sch. 2paras. 2, 3); 2020 c. 1, Sch. 5 para. 1(1) 2 and 2A have effect.]F5 Regs. 1ZA, 1A inserted ( ) ( ) by The Medical Devices (Amendment etc.)

5 (EU Exit) Regulations 2019 ( 2019/791), regs. 1(1), 3(2) (as amended by 2020/1478, reg. 1(3), Sch. 2paras. 2, 3); 2020 c. 1, Sch. 5 para. 1(1)Interpretation E+W+S2. (1) in these active implantable Medical device means a Medical device which (a)relies for its functioning on a source of electrical energy or a source of power other thanthat generated directly by the human body or by gravity; and(b)is intended to be totally or partially introduced into the human body (whether surgicallyor medically, including being introduced into a natural orifice) and which is intended toremain in the human body after completion of the surgical or Medical procedure duringwhich it is introduced,even if it is intended to administer a medicinal product or incorporates as an integral part asubstance which, if used separately, would be a medicinal product ; [F10 approved body is to be construed in accordance with regulation A45.]

6 ] CE marking means a conformity marking consisting of the initials CE ; [F14 clinical data means the safety or performance information that is generated from the useof a device, derived from (a)clinical investigations of the device concerned; or(b)clinical investigations or other studies reported in scientific literature of a similar devicefor which equivalence to the device in question can be demonstrated; or(c)published or unpublished reports on other clinical experiences of either the device inquestion or a similar device for which equivalence to the device in question can bedemonstrated;]2 Document Generated: 2022-03-31 Changes to legislation: The Medical Devices Regulations 2002 is up to date with all changes known to be in force on orbefore 31 March 2022.

7 There are changes that may be brought into force at a future date. Changes that have been madeappear in the content and are referenced with annotations. (See end of Document for details) View outstanding changes[F15 coronavirus test device means an in vitro diagnostic Medical device for the detectionof the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2);][F16designated standard has the meaning given in regulation 3A;] device for performance evaluation means a product which is intended by its manufacturer tobe subject to one or more performance evaluation studies in laboratories for Medical analysisor in other appropriate environments outside his own premises;[F17 Directive 90/385 means Council Directive 90/385/EEC of 20 June 1990 on theapproximation of the laws of Member States relating to active implantable Devices [F18as it hadeffect immediately before IP completion day].]

8 ][F19 Directive 93/42 means Council Directive 93/42/EEC of 14 June 1993 concerning medicaldevices [F20as it had effect immediately before IP completion day];][F21 Directive 98/79 means Directive 98/79/EC of the European Parliament and of the Councilof 27 October 1998 on in-vitro diagnostic Medical Devices [F22as it had effect immediatelybefore IP completion day];] [F24 Directive 2003/12 means Commission Directive 2003/12 of 3rd February 2003 onthe reclassification of breast implants in the framework of Directive 93/42/EEC concerningmedical Devices ;] [F26 Directive 2005/50 means Commission Directive 2005/50/EC of 11 August 2005 on thereclassification of hip, knee and shoulder joint replacements in the framework of CouncilDirective 93/42/EEC concerning Medical Devices .

9 ][F27 Directive 2007/47 means Directive 2007/47/EC of the European Parliament and of theCouncil amending Council Directive 90/385/EEC on the approximation of the laws of theMember States relating to active implantable Medical Devices , Council Directive 93/42/EECconcerning Medical Devices and Directive 98/8/EC concerning the placing of biocidal productson the market;] CAB shall be construed in accordance with regulation 48(1); [F33 hazard means a potential source of injury or damage to health;][F34 hip, knee or shoulder replacement means an implantable component part of a total jointreplacement system which is intended to provide a function similar to that of either a natural hipjoint, a natural knee joint or a natural shoulder joint, other than ancillary components (screws,wedges, plates and instruments);][F35 intended for clinical investigation means (a)intended for use by a registered Medical practitioner when conducting investigations ofthat device in an adequate human clinical environment.

10 Or3 Document Generated: 2022-03-31 Changes to legislation: The Medical Devices Regulations 2002 is up to date with all changes known to be in force on orbefore 31 March 2022. There are changes that may be brought into force at a future date. Changes that have been madeappear in the content and are referenced with annotations. (See end of Document for details) View outstanding changes(b)intended for use by any other person in [F36 Great Britain] who, by virtue of theirprofessional qualification, is authorised to carry out investigations of that device in anadequate human clinical environment;] intended purpose means (a)in relation to an active implantable Medical device, the use for which it is intended and forwhich it is suited according


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