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The Medical Devices Regulations 2002
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Changes to legislation:
The Medical Devices Regulations 2002, Section 46 is up to date with all changes known to be in force on or before 04 November 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.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
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))
[F2Choice of approved bodies and conformity assessment bodies]E+W+S
46. Where a conformity assessment procedure involves the intervention of [F3an approved body], including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or [F4the manufacturer’s UK responsible person] may apply to [F5any approved body] or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.
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
F2Reg. 46 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), 7(5)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 46 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(5)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in reg. 46 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(5)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in reg. 46 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(5)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)
Choice of notified bodies and conformity assessment bodiesN.I.
46. Where a conformity assessment procedure involves the intervention of a notified body, including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or his authorised representative may apply to any notified body or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.
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
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