# The Medical Devices (Amendment) (EU Exit) Regulations 2021, Paragraph 13


In regulation 24 (UK marking of active implantable medical devices), after paragraph (5), insert—
“(6) In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—
(a) as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and
(b) as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).”.

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Source: https://www.legislation.gov.uk/uksi/2021/873/schedule/1/paragraph/13 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-1/paragraph-13
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.