# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Regulation 10C: UK(NI) indication under Regulation (EU) 2017/746


(1) This regulation applies if the CE marking is affixed in accordance with Article 18 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.
(5) A person may only make available on the market a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.

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Source: https://www.legislation.gov.uk/uksi/2021/905/regulation/10C (the official version)
Page: https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-10C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.