Paragraph 10

In regulation 10^f1 (UK marking of general 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).”.