The Medical Devices (Amendment) (EU Exit) Regulations 2021

32.  In Annex II (the application form to be submitted when applying for designation as an approved body) —

(a) in the title for “notified” substitute “an approved”;

(b) in the fourth line of the application form, for “EU Notified” substitute “Approved”;

(c) in the table of documents to be submitted—

(i) in box 4 omit from “,either within the Member State” to the end,

(ii) in box 15 for “the designating authority” to the end substitute “the Secretary of State”,

(iii) in boxes 17 and 18 for “notified body”, substitute “approved body”,

(iv) in box 31 for “notified” in each place it occurs substitute “approved”,

(v) in box 41 for “Communications from regulatory authorities including competent authorities and designating authorities” substitute “Communications from the Secretary of State or other regulatory authorities”.