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Regulation 51 Products incorrectly marked with a UK markingF2E1

England, Wales and Scotland

(1)

No person shall—

(a)

affix the F1UK marking for a medical device to a product which is not a medical device; or

(b)

supply a product (if that supply is also a placing on the market, or if that supply is of a product which has been placed on the market) which has affixed to it the UK marking for a medical device if that product is not a medical device.

(2)

No person shall provide information comprising a UK marking for a medical device on a product, the instructions for use for a product, or the sales packaging for a product if the product is not a medical device.

Annotations

Textual amendments

F1

Words in reg. 51 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(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in reg. 51 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(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

Extent

E1

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

Notes on Part V

Textual amendments

F1

Words in Pt. 5 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(2) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)