SCHEDULE 2Amendments to EU tertiary legislation
PART 4
Amendments to Commission Implementing Regulation 920/2013
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.