http://www.legislation.gov.uk/uksi/2002/618/regulation/13The Medical Devices Regulations 2002texttext/xmlenStatute Law DatabaseCONSUMER PROTECTION2026-04-09Expert Participation2026-04-01 These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93/42/EEC concerning medical devices, as amended; and Directive 98/79/EC of the European Parliament and of the Council onin vitro diagnostic medical devices (“the Medical Devices Directives”). They also contain the legislative measures necessary for the implementation, in relation to medical devices, of the agreements on mutual recognition between the European Community and Australia, New Zealand, Canada and the United States of America—and of the Association Agreement between the European Communities, and their Member States, and Hungary. The Medical Devices Regulations 2002Pt. 8The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 10reg. 1(1)The Medical Devices Regulations 2002Pt. 9The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 11reg. 1(1)The Medical Devices Regulations 2002reg. 4B-4CThe Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 3(7)reg. 1(1)The Medical Devices Regulations 2002reg. 4D(10)(b)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 2(3)(a)reg. 1The Medical Devices Regulations 2002reg. 4E-4GThe Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 3(7)reg. 1(1)The Medical Devices Regulations 2002reg. 4E(7)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 2(3)(b)reg. 1The Medical Devices Regulations 2002reg. 4Q-4SThe Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 3(7)reg. 1(1)The Medical Devices Regulations 2002reg. 6(d)The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 4(2)reg. 1(1)The Medical Devices Regulations 2002reg. 33(1)(c)The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 6(2)(a)reg. 1(1)The Medical Devices Regulations 2002reg. 33(2)(c)The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019reg. 6(2)(b)reg. 1(1)The Medical Devices Regulations 2002reg. 75(3)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 9(2)(a)reg. 1The Medical Devices Regulations 2002reg. 75(7)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 9(2)(b)reg. 1The Medical Devices Regulations 2002reg. 93(4)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 9(3)reg. 1The Medical Devices Regulations 2002reg. 119(6)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 9(4)reg. 1The Medical Devices Regulations 2002reg. 124(5)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 9(5)reg. 1The Medical Devices Regulations 2002reg. 149(5)(e)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 10(2)reg. 1The Medical Devices Regulations 2002reg. 158(1)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 10(3)(a)reg. 1The Medical Devices Regulations 2002reg. 158(3)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 10(3)(b)reg. 1The Medical Devices Regulations 2002Sch. 19 para. 5The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 11(2)(a)reg. 1The Medical Devices Regulations 2002Sch. 19 para. 5The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 11(2)(b)reg. 1The Medical Devices Regulations 2002Sch. 24 para. 1(7) headingThe Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 11(3)(a)reg. 1The Medical Devices Regulations 2002Sch. 24 para. 1(7)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 2 para. 11(3)(b)reg. 1The Medical Devices Regulations 2002reg. 60A-60CMedicines and Medical Devices Act 2021Sch. 3 para. 1s. 50(3)The Medical Devices Regulations 2002reg. 60AMedicines and Medical Devices Act 2021Sch. 2 para. 4s. 50(3)The Medical Devices Regulations 2002reg. 60AMedicines and Medical Devices Act 2021Sch. 2 para. 5(2)s. 50(3)The Medical Devices Regulations 2002Sch. 3Medicines and Medical Devices Act 2021Sch. 3 para. 2s. 50(3) PART II131A relevant device falling within Class I may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by Annex VII;bdeclares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.2A relevant device falling within Class IIa may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex II, excluding Section 4 of that Annex, oriiAnnex VII, together with Annex IV, V or VI;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.3A relevant device falling within Class IIb may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex II, excluding Section 4 of that Annex, oriiAnnex III, together with Annex IV, V or VI;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.4A relevant device falling within Class III may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex II, oriiAnnex III, together with Annex IV or V;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; ...censures that the device meets the provisions of this Part which apply to it; and dfulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131A relevant device falling within Class I may bear a CE marking only if its manufacturer or his authorised representative—afulfils the applicable obligations imposed by Annex VII;bdeclares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it; andcensures that the device meets the provisions of Directive 93/42 which apply to it.2A relevant device falling within Class IIa may bear a CE marking only if its manufacturer or his authorised representative—afulfils the applicable obligations imposed by—iAnnex II, excluding Section 4 of that Annex, oriiAnnex VII, together with Annex IV, V or VI;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; andcensures that the device meets the provisions of Directive 93/42 which apply to it.3A relevant device falling within Class IIb may bear a CE marking only if its manufacturer or his authorised representative—afulfils the applicable obligations imposed by—iAnnex II, excluding Section 4 of that Annex, oriiAnnex III, together with Annex IV, V or VI;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; andcensures that the device meets the provisions of Directive 93/42 which apply to it.4A relevant device falling within Class III may bear a CE marking only if its manufacturer or his authorised representative—afulfils the applicable obligations imposed by—iAnnex II, oriiAnnex III, together with Annex IV or V;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; ...censures that the device meets the provisions of Directive 93/42 which apply to it; and dfulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)Words in reg. 13 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c)Word in reg. 13(4)(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(b)Reg. 13(5)(6) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(3)Word in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a)Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyThis version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyWord in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a)Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c)Reg. 13(5)(6) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(3)Word in reg. 13(4)(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(b)