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Version Superseded: 11/08/2021
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The Medical Devices Regulations 2002, Section 36 is up to date with all changes known to be in force on or before 26 August 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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36.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a [F2UK marking] which—
(a)meets the requirements set out in [F3Annex 2 of Regulation 765/2008];
(b)is in a visible, legible and indelible form; and
(c)is accompanied by any relevant [F4approved body] or conformity assessment body identification number for that device.
(2) Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a [F2UK marking] which—
(a)meets the requirements set out in [F3Annex 2 of Regulation 765/2008];
(b)is in a visible, legible and indelible form; and
(c)is accompanied by any relevant [F4approved body] or conformity assessment body identification number for that device,
if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.
(3) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a [F2UK marking], meeting the requirements set out in [F3Annex 2 of Regulation 765/2008], appears on—
(a)any sales packaging for that device; and
(b)the instructions for use for that device,
and that [F2UK marking] is accompanied by any relevant [F4approved body] or conformity assessment body identification number for that device.
(4) Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a [F2UK marking], meeting the requirements set out in [F3Annex 2 of Regulation 765/2008], appears on—
(a)any sales packaging for that device; and
(b)the instructions for use for that device,
and that [F2UK marking] is accompanied by any relevant [F4approved body] or conformity assessment body identification number for that device.
(5) Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—
(a)a relevant device;
(b)the instructions for use for a relevant device; or
(c)any sales packaging for a relevant device,
which is likely to mislead a third party with regard to the meaning or the graphics of the [F2UK marking] or which reduces the visibility or the legibility of the [F2UK marking].
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
F1Words in reg. 36 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), 6(4A)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 36 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4A)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 36 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4A)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in reg. 36 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4A)(d) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1)
36.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a CE marking which—
(a)meets the requirements set out in Annex X;
(b)is in a visible, legible and indelible form; and
(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device.
(2) Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a CE marking which—
(a)meets the requirements set out in Annex X;
(b)is in a visible, legible and indelible form; and
(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device,
if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.
(3) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex X, appears on—
(a)any sales packaging for that device; and
(b)the instructions for use for that device,
and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.
(4) Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex X, appears on—
(a)any sales packaging for that device; and
(b)the instructions for use for that device,
and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.
(5) Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—
(a)a relevant device;
(b)the instructions for use for a relevant device; or
(c)any sales packaging for a relevant device,
which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.
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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