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.