- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (26/05/2021)
- Gwreiddiol (a wnaed Fel)
Version Superseded: 11/08/2021
Point in time view as at 26/05/2021.
The Medical Devices Regulations 2002, PART VII is up to date with all changes known to be in force on or before 03 October 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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59. In this PartF1...—
[F2“registrable device” means a device in respect of which, in accordance with the Medical Devices Directives, registration is required with the competent authorities of a Member State or (where appropriate) a State which is a Party to an Association Agreement;]
“relevant device” means a device that is a “relevant device” for the purposes of Part II, III or IV [F3or a device for the purposes of Part VIII or IX.] .
Textual Amendments
F1Words in reg. 59 omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 17
F2Words in reg. 59 omitted (E.W.S.) (30.4.2021) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(2)(e), 9(2)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 59 inserted (E.W.S.) (30.4.2021) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(2)(e), 9(2)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
60.—F5(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F5(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F6(3) A UK responsible person—
(a)may be proceeded against as a person placing the device on the market for the purposes of these regulations;
(b)in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.]
(4) If a person claims or purports to act as [F7a UK responsible person], the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient [F8evidence that he is [F9a UK responsible person]].
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F4Reg. 60 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), 9(3)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F5Reg. 60(1)(2) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F6Reg. 60(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in reg. 60(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(d)(i) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 8 and S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in reg. 60(4) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(b)
F9Words in reg. 60(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(d)(ii) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 8 and S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
60.—(1) Where these Regulations place any obligationF18... on a manufacturer of a device or his authorised representative, and the manufacturer does not have a registered place of business [F19in a relevant state], no person shall—
(a)place that device on the market; or
(b)supply that device in circumstances where it has been placed on the market,
unless the manufacturer of the device has designated [F20a single authorised representative] to perform that obligation, but once the manufacturer has designated [F20a single authorised representative] to perform that obligation, that obligation shall be performed by the authorised representative (although in all other cases it shall be performed by the manufacturer).
(2) If the manufacturer of a registrable device does not have a registered place of business [F21in a relevant state], no person shall place that device on the market or supply that device in circumstances where it has been placed on the market unless its manufacturer has designated [F20a single authorised representative] as—
(a)the person responsible for marketing the device [F22in a relevant state]; and
(b)the person responsible for registering in respect of that device with—
(i)the Secretary of State in accordance with regulation 19 or, as the case may be, 44, or
(ii)the competent authorities of another Member State or (where appropriate) a State which is a Party to an Association Agreement.
(3) Where a manufacturer of a registrable device, or of a relevant device that is not registrable, has designated [F20a single authorised representative] as the person responsible for marketing the device within [F23a relevant state], that authorised representative—
(a)may be proceeded against as a person placing the device on the market for the purposes of these Regulations;
(b)in relation to any supply of the device to a person within [F24Northern Ireland] after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market, unless that supply is due to an act of another person established in [F25a relevant state].
(4) If a person claims or purports to act as an authorised representative of a manufacturer of a device, the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient [F26evidence that he is the single authorised representative of the manufacturer].
Extent Information
E3This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F18Words in reg. 60(1) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(a)(i)
F19Words in reg. 60(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(a)(ii)
F20Words in reg. 60(1)(2)(3) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(a)
F21Words in reg. 60(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(b)(i)
F22Words in reg. 60(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(b)(ii)
F23Words in reg. 60(3) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(c)(i)
F24Words in reg. 60(3)(b) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(c)(ii)(aa)
F25Words in reg. 60(3)(b) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(c)(ii)(bb)
F26Words in reg. 60(4) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(b)
[F1061.—(1A) It is the duty of the Secretary of State to enforce these regulations in relation to relevant devices and devices for performance evaluation.
(1B) It is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these regulations within its area (concurrently with the Secretary of State) in relation to relevant devices that are ordinarily intended for private use or consumption.
(1C) Nothing in this regulation authorises a weights and measures authority to bring proceedings in Scotland for an offence.]
Textual Amendments
F10 Reg. 61(1A)-(1C) substituted for reg. 61(1)-(8) (26.5.2021) by Medicines and Medical Devices Act 2021 (c. 3), ss. 41(6), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3)
61.—(1) Notwithstanding that they are made partly in exercise of powers other than those conferred by section 11 of the 1987 Act, these Regulations shall be regarded for all purposes relating to enforcement (whether by criminal proceedings, notices or otherwise) F27... as safety regulations as defined in that Act F28, and any provision of these Regulations made under those other powers shall be regarded for those purposes as a safety provision as defined in that Act M8.
[F29(1A) Paragraph (1) applies in relation to regulations 10A, 24A and 36A (UK(NI) indication) as it does in relation to any other provision of these Regulations to which it applies.]
(2) Except as provided by paragraph (3), F30... each district council in Northern Ireland is relieved of its duty imposed by section 27(1) of the 1987 Act in so far as it is exercisable in relation to relevant devices or devices for performance evaluation, and that duty is transferred to the Secretary of State.
(3) Paragraph (2) does not relieve an authority or council of its duty in relation to devices which are consumer goodsF31..., and accordingly but subject to paragraph (4), F32... each district council in Northern Ireland shall, concurrently with the Secretary of State, enforce these Regulations in relation to such devices.
(4) The powers of an enforcement authority to serve restriction notices under regulation 63 are only exercisable by the Secretary of State.
(5) Each F33... council referred to in paragraph (3) on whom a duty is imposed by section 27(1) of the 1987 Act to enforce the provisions of these Regulations shall give immediate notice to the Secretary of State of—
(a)any suspension notice served by it under section 14 of the 1987 Act in respect of a device to which paragraph (3) applies;
(b)any application made by it under section 16 of the 1987 Act for an order for forfeiture of any such device; and
(c)any other thing done by it in respect of such a device for the purposes of, or in connection with the operation of, sections 14 to 17 of the 1987 Act.
[F34(6) In respect of an offence committed under section 12 of the 1987 Act relating to a contravention of these Regulations—
F35(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(b)a magistrates’ court in Northern Ireland may hear and determine any complaint made—
(i)if the offence was committed before 10th March 2007, within 12 months from the time when the offence is committed, or
(ii)if the offence was committed on or after 10th March 2007, within three years from the time when the offence was committed or within one year from the discovery of the offence by the prosecutor, whichever is the earlier; and
F36(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]
(7) The powers conferred by section 13 of the 1987 Act to serve prohibition notices and notices to warn are exercisable in relation to non—conforming devices as they are exercisable in relation to relevant goods which the Secretary of State considers are unsafe (as well as being exercisable in relation to goods considered unsafe by the Secretary of State), and in relation to non-conforming devices, Schedule 2 to the 1987 Act shall have effect as if references to goods being unsafe or safe were references to relevant devices being or not being non-conforming devices.
[F37(7A) In paragraph (3), “consumer goods” means any goods which are ordinarily intended for private use or consumption.]
(8) In paragraph (7), “non-conforming devices” means—
(a)relevant devices which, whether or not the Secretary of State considers them unsafe, are devices with or that require a CE marking which he considers to be devices—
(i)which do not conform as respects a relevant essential requirement [F38or a requirement of Regulation (EU) No 722/2012 (if applicable)]; or
(ii)to which a CE marking has or should have been applied following a conformity assessment procedure set out in the Medical Devices Directives, and—
(aa)the manufacturer or his authorised representative has failed to comply with his obligations under that procedure, or
(bb)they do not conform to the design or type described in any certificate granted as a result of that procedure; or
(b)devices for performance evaluation which, whether or not the Secretary of State considers them unsafe, are devices in respect of which there is a failure to comply with these Regulations.
Extent Information
E4This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F27Words in reg. 61(1) revoked (20.6.2003) by The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Amendment and Specification) Order 2003 (S.I. 2003/1400), art. 1, Sch. 5
F28 See section s 11(1) and 45(1) of that Act.
F29Reg. 61(1A) inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(a)
F30Words in reg. 61(2) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(b)
F31Words in reg. 61(3) omitted (22.11.2005) by virtue of The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(a)
F32Words in reg. 61(3) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(c)
F33Words in reg. 61(5) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(d)
F34Reg. 61(6) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 6
F35Reg. 61(6)(a) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(e)
F36Reg. 61(6)(c) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(e)
F37Reg. 61(7A) inserted (22.11.2005) by The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(b)
F38Words in reg. 61(8)(a)(i) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 17
Marginal Citations
M8 See section 45(1) of that Act.
F1162. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F11Reg. 62 omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(7)(a), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3)
F1263. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F12Reg. 63 omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(7)(b), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3)
F1364. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F13Reg. 64 omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(7)(c), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3)
65. The Secretary of State shall perform, as respects [F15Northern Ireland], the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to (3) of Directive 98/79.]
Textual Amendments
F14Reg. 65 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F15Words in reg. 65 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 26
66. The following provisions are hereby revoked—
(a)the Active Implantable Medical Devices Regulations 1992 M1;
(b)the Medical Devices Regulations 1994 M2;
(c)the Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 M3;
(d)the Medical Devices Fees Regulations 1995 M4;
(e)the Medical Devices Fees (Amendment) Regulations 1997 M5;
(f)theIn Vitro Diagnostic Medical Devices Regulations 2000 M6; and
(g)regulations 6 and 13 of the Medicines (Codification Amendments Etc.) Regulations 2002 M7.
Marginal Citations
67. Before the end of 31st December [F172025], the Secretary of State must—
(a)carry out a review of these Regulations;
(b)set out the conclusions of the review in a report; and
(c)publish the report.]
Extent Information
E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F16Reg. 67 inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 18
F17Word in reg. 67 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(8) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
67. Before the end of 31st December 2019, the Secretary of State must—
(a)carry out a review of these Regulations;
(b)set out the conclusions of the review in a report; and
(c)publish the report.]
Extent Information
E5This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F39Reg. 67 inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 18
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