The Medical Devices Regulations 2002

Enforcement etc. E+W+S

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) F1 ... as safety regulations as defined in that Act M1 , 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 M2 .

(2) Except as provided by paragraph (3), each weights and measures authority in Great Britain and 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 goodsF2 ..., and accordingly but subject to paragraph (4), each weights and measures authority in Great Britain and 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 authority and 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.

[F3 (6) In respect of an offence committed under section 12 of the 1987 Act relating to a contravention of these Regulations—

(a) a magistrates’ court in England or Wales may try any information laid—

(i) if the offence was committed before 10th March 2007, within 12 months from the time when the offence is committed, or

(ii) if 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;

(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

(c) in Scotland, summary proceedings for the offence may be commenced—

(i) if the offence was committed before 10th March 2007, at any time 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.]

(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.

[F4 (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 [F5 UK marking] which he considers to be devices—

(i) which do not conform as respects a relevant essential requirement [F6 , a general safety and performance requirement] [F7 or a requirement of Regulation (EU) No 722/2012 (if applicable)]; or

(ii) to which a [F5 UK marking] has or should have been applied following a conformity assessment procedure F8 ..., and—

(aa) the manufacturer or [F9 their UK responsible person] 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

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Words 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

F2 Words 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)

F3 Reg. 61(6) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 6

F4 Reg. 61(7A) inserted (22.11.2005) by The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(b)

F5 Words in reg. 61 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(4)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 51); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 61(8)(a)(i) inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(4)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 51); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words 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

F8 Words in reg. 61(8)(a)(ii) 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(4)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 51); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in reg. 61(8)(a)(ii)(aa) 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(4)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 51); 2020 c. 1, Sch. 5 para. 1(1)

Marginal Citations

M1 See section s 11(1) and 45(1) of that Act.

M2 See section 45(1) of that Act.

Enforcement etc. N.I.

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) F10 ... as safety regulations as defined in that Act F11 , 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 M3 .

[F12 (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), F13 ... 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 goodsF14 ..., and accordingly but subject to paragraph (4), F15 ... 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 F16 ... 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.

[F17 (6) In respect of an offence committed under section 12 of the 1987 Act relating to a contravention of these Regulations—

F18 (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

F19 (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.

[F20 (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 [F21 or 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

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F10 Words 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

F11 See section s 11(1) and 45(1) of that Act.

F12 Reg. 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)

F13 Words 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)

F14 Words 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)

F15 Words 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)

F16 Words 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)

F17 Reg. 61(6) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 6

F18 Reg. 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)

F19 Reg. 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)

F20 Reg. 61(7A) inserted (22.11.2005) by The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(b)

F21 Words 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

M3 See section 45(1) of that Act.