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

24.  In Article 3 (which relates to the procedure for the designation of notified bodies, now of approved bodies)—

(a) In its heading, for “notified” substitute “approved”;

(b) in paragraph 1, in the first sub-paragraph, for “a notified body” substitute “an approved body”;

(c) in paragraph 1, in the second sub-paragraph—

(i) for “notified” substitute “approved”,

(ii) for “used in the New Approach Notified Designated Organisations Information System and subdivisions of those fields.” substitute “found in Guidance: UK approved bodies for medical devices https://www.gov.uk/publications/medical-devices-uk-approved-bodies-for-medical-devices.”;

(d) in paragraph 2—

(i) in the first sub-paragraph, for “The designating authority of the Member State where the conformity assessment body is established” substitute “The Secretary of State”;

(ii) omit the second sub-paragraph.

(e) omit paragraphs 3 to 6;

(f) in paragraph 7 omit the first sub-paragraph.