SCHEDULE 2Amendments to EU tertiary legislation

PART 4

Amendments to Commission Implementing Regulation 920/2013

25

In Article 4(extension of renewal of designation)—

a

in paragraph 1, for “notified” substitute “approved”;

b

in paragraph 2, for “notified” substitute “an approved”;

c

for paragraph 5, substitute—

5

An approved body, within the meaning of regulation A45(1)(b) of the Medical Devices Regulations 2002, whose designation does not have a stated validity period or has a validity period exceeding five years, is to be subject to a renewal within five years of IP completion day