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The Medical Devices (Northern Ireland Protocol) Regulations 2021
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- UK Statutory Instruments
- 2021 No. 905
- PART 2
- Regulation 10
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UK(NI) indication [F1under Regulation (EU) 2017/745] N.I.
This section has no associated Explanatory Memorandum
10.—(1) This regulation applies if the CE marking is affixed in accordance with Article 20 on the basis of a certificate issued by a notified body established in the United Kingdom.
(2) The CE marking must be accompanied by the UK(NI) indication.
(3) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.
(4) The manufacturer must affix the UK(NI) indication—
(a)visibly, legibly and indelibly, and
(b)before placing the device on the market F2....
(5) A person may only make available on the market F3... a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.
F4(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Words in reg. 10 heading inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 32(a)
F2Words in reg. 10(4)(b) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 32(b)
F3Words in reg. 10(5) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 32(c)
F4Reg. 10(6) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 32(d)
Commencement Information
I1Reg. 10 in force at 27.7.2021, see reg. 1(2)
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