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

This section has no associated Explanatory Memorandum

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.