Regulation 10 UK(NI) indication under Regulation (EU) 2017/745F4I1
Northern Ireland
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.
The CE marking must be accompanied by the UK(NI) indication.
The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.
The manufacturer must affix the UK(NI) indication—
visibly, legibly and indelibly, and
before placing the device on the market F1....
A person may only make available on the market F2... a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annotations
Textual amendments
- F1
Words 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)
- F2
Words 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)
- F3
Reg. 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)
- F4
Words 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)
Commencement
- I1
Reg. 10 in force at 27.7.2021, see reg. 1(2)