PART III U.K. Active Implantable Medical Devices

[F1 UK marking] of active implantable medical devices E+W+S

24.—(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a [F2 UK marking] which—

(a) meets the requirements set out in [F3 Annex 2 of Regulation 765/2008];

(b) is in a visible, legible and indelible form; and

(c) is accompanied by any relevant [F4 approved body] or conformity assessment body identification number for that device.

(2) Subject to regulation 26, no person shall supply a relevant device unless that device or its sterile pack bears a [F2 UK marking] which—

(a) meets the requirements set out in [F3 Annex 2 of Regulation 765/2008];

(b) is in a visible, legible and indelible form; and

(c) is accompanied by any relevant [F5 approved 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 26, no person shall place on the market or put into service a relevant device unless a [F2 UK marking], meeting the requirements set out in [F3 Annex 2 of Regulation 765/2008], appears on—

(a) where appropriate, any sales packaging for that device; and

(b) the instructions for use for the device,

and that [F2 UK marking] is accompanied by any relevant [F6 approved body] or conformity assessment body identification number for that device.

(4) Subject to regulation 26, 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 [F2 UK marking], meeting the requirements set out in [F3 Annex 2 of Regulation 765/2008], appears on—

(a) where appropriate, any sales packaging for that device; and

(b) the instructions for use for the device,

and that [F2 UK marking] is accompanied by any relevant [F7 approved body] or conformity assessment body identification number for that device.

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a) a relevant device or its sterile pack;

(b) the instructions for use for a relevant device; or

(c) where appropriate, 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 [F2 UK marking] or which reduces the visibility or the legibility of the [F2 UK marking].

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. 24 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), 5(4A)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 24 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 24 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 24(1)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 24(2)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 24(3)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 24(4)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

CE marking of active implantable medical devices N.I.

24.—(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a CE marking which—

(a) meets the requirements set out in Annex 9;

(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 26, no person shall supply a relevant device unless that device or its sterile pack bears a CE marking which—

(a) meets the requirements set out in Annex 9;

(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 26, 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 9, appears on—

(a) where appropriate, any sales packaging for that device; and

(b) the instructions for use for the 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 26, 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 9, appears on—

(a) where appropriate, any sales packaging for that device; and

(b) the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a) a relevant device or its sterile pack;

(b) the instructions for use for a relevant device; or

(c) where appropriate, 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

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