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The Medical Devices Regulations 2002

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Changes and effects yet to be applied to Regulation 48:

  • reg. 48 heading word omitted by S.I. 2019/791 reg. 7(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 7 substituted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 47)
  • reg. 48 word omitted by S.I. 2019/791 reg. 7(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 7 substituted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 47)
  • reg. 48 heading word omitted by virtue of S.I. 2019/791, reg. 7(4)(a) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48 words substituted by S.I. 2019/791 reg. 7(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 7 substituted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 47)
  • reg. 48(1) words omitted by S.I. 2019/791 reg. 7(4)(c) (This amendment not applied to legislation.gov.uk. Reg. 7 substituted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 47)
  • reg. 48(1) words omitted by virtue of S.I. 2019/791, reg. 7(4)(b)(i) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(1) words substituted by S.I. 2019/791, reg. 7(4)(b)(ii) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(1) words substituted by S.I. 2019/791, reg. 7(4)(e) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(2) words substituted by S.I. 2019/791, reg. 7(4)(c) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(2) words substituted by S.I. 2019/791, reg. 7(4)(e) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(4) words substituted by S.I. 2019/791, reg. 7(4)(c) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(5) words substituted by S.I. 2019/791, reg. 7(4)(c) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(5) words substituted by S.I. 2019/791, reg. 7(4)(e) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(6) word omitted by virtue of S.I. 2019/791, reg. 7(4)(d) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(7) words substituted by S.I. 2019/791, reg. 7(4)(c) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(7) words substituted by S.I. 2019/791, reg. 7(4)(e) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(8) words substituted by S.I. 2019/791, reg. 7(4)(c) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))
  • reg. 48(8) words substituted by S.I. 2019/791, reg. 7(4)(e) (as substituted) by S.I. 2019/1385 Sch. 2 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 6 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(b))

Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:

Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):

  • Pt. 8 inserted by S.I. 2019/791 reg. 10 (This amendment not applied to legislation.gov.uk. Reg. 10 omitted immediately before IP completion day by virtue of S.I. 2020/1478, regs. 1(3), Sch. 2 para. 54)
  • Pt. 9 inserted by S.I. 2019/791 reg. 11 (This amendment not applied to legislation.gov.uk. Reg. 11 omitted immediately before IP completion day by virtue of S.I. 2020/1478, regs. 1(3), Sch. 2 para. 55)
  • Sch. 3 inserted by 2021 c. 3 Sch. 3 para. 2
  • Sch. 19 para. 5 words substituted by S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(2)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • Sch. 19 para. 5 words substituted by S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(2)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • Sch. 24 para. 1(7) heading words omitted by virtue of S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • Sch. 24 para. 1(7) words omitted by virtue of S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 4D(10)(b) substituted by S.I. 2019/791, reg. 3(7) (as amended) by S.I. 2019/1385 Sch. 2 para. 2(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 2(3) omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(a)(ii))
  • reg. 4E(7) words substituted by S.I. 2019/791, reg. 3(7) (as amended) by S.I. 2019/1385 Sch. 2 para. 2(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 2(3) omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(a)(ii))
  • reg. 6(d) inserted by S.I. 2019/791 reg. 4(2) (This amendment not applied to legislation.gov.uk. Reg. 4(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 10)
  • reg. 33(1)(c) inserted by S.I. 2019/791 reg. 6(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 6(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 35)
  • reg. 33(2)(c) inserted by S.I. 2019/791 reg. 6(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 6(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 35)
  • reg. 60A excluded by 2021 c. 3 Sch. 2 para. 4
  • reg. 60A excluded by 2021 c. 3 Sch. 2 para. 5(2)
  • reg. 60A-60C inserted by 2021 c. 3 Sch. 3 para. 1
  • reg. 75(3) words inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(2)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 75(7) inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(2)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 93(4) inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(3) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 119(6) words inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(4) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 124(5) words substituted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(5) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 149(5)(e) words substituted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(2) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 158(1) substituted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
  • reg. 158(3) inserted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))

Designation etc. of F2... conformity assessment bodiesE+W+S

48.—(1) The Secretary of State may designate for the purposes of [F3a mutual recognition agreement] any corporate or other body as a body which is to carry out any of the tasks of a F4... conformity assessment body, and, if he so designates a body (referred to in these Regulations as [F5a “CAB”]), he shall designate the tasks which it is to carry out.

(2) A body may be designated under paragraph (1) as a body which is to carry out tasks of [F6a CAB] only if the Secretary of State considers that the body is capable of fulfilling the functions of [F6a CAB] arising out of [F7a mutual recognition agreement] which it needs to be able to fulfil.

(3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

(4) The Secretary of State may vary the tasks that [F8a CAB] may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

(5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

(a)the body so requests; or

(b)he considers that the body is not capable of fulfilling the functions of [F9a CAB] arising out of [F10a mutual recognition agreement] which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

(6) Before—

(a)effecting a variation under paragraph (4); or

(b)restricting or withdrawing a designation under paragraph (5),

otherwise than at the F11... CAB’s request, the Secretary of State shall give to the F11... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

(7) For the purpose of deciding whether or not a body is capable of fulfilling the functions of [F12a CAB] arising out of [F13a mutual recognition agreement] which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

(8) The Secretary of State may request that [F14a CAB] supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of [F14a CAB] arising out of [F15a mutual recognition agreement] which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

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

Designation etc. of F16... conformity assessment bodiesN.I.

48.—(1) The Secretary of State may designate for the purposes of [F17a UK mutual recognition agreement] any corporate or other body as a body which is to carry out any of the tasks of a F18... conformity assessment body, and, if he so designates a body (referred to in these Regulations as [F19a “CAB”]), he shall designate the tasks which it is to carry out.

(2) A body may be designated under paragraph (1) as a body which is to carry out tasks of [F20a CAB] only if the Secretary of State considers that the body is capable of fulfilling the functions of [F20a CAB] arising out of [F21a UK mutual recognition agreement] which it needs to be able to fulfil.

(3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

(4) The Secretary of State may vary the tasks that [F22a CAB] may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

(5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

(a)the body so requests; or

(b)he considers that the body is not capable of fulfilling the functions of [F23a CAB] arising out of [F24a UK mutual recognition agreement] which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

(6) Before—

(a)effecting a variation under paragraph (4); or

(b)restricting or withdrawing a designation under paragraph (5),

otherwise than at the F25... CAB’s request, the Secretary of State shall give to the F25... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

(7) For the purpose of deciding whether or not a body is capable of fulfilling the functions of [F26a CAB] arising out of [F27a UK mutual recognition agreement] which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

(8) The Secretary of State may request that [F28a CAB] supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of [F28a CAB] arising out of [F29a UK mutual recognition agreement] which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F16Word in reg. 48 heading 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. 18(a)

F17Words in reg. 48(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. 18(b)(i)

F18Words in reg. 48(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. 18(b)(ii)

F19Words in reg. 48(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. 18(b)(iii)

F20Words in reg. 48(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. 18(c)(i)

F21Words in reg. 48(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. 18(c)(ii)

F22Words in reg. 48(4) 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. 18(d)

F23Words in reg. 48(5) 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. 18(e)(i)

F24Words in reg. 48(5) 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. 18(e)(ii)

F25Words in reg. 48(6) 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. 18(f)

F26Words in reg. 48(7) 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. 18(g)(i)

F27Words in reg. 48(7) 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. 18(g)(ii)

F28Words in reg. 48(8) 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. 18(h)(i)

F29Words in reg. 48(8) 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. 18(h)(ii)

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