PART 4Amendments to the Medical Devices (Northern Ireland Protocol) Regulations 2021
Amendment to Schedule 2 (fees in connection with the designation of notified bodies)43
In Schedule 2—
a
the first column (application) in Table 1 (application fees) is amended as follows—
i
at the end of entry 1 insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”
;
ii
in entry 2, after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”
;
iii
at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”
;
iv
in entry 4—
aa
after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”
;
bb
after “an Annex” insert “to Regulation (EU) 2017/745 or Regulation (EU) 2017/746”
;
v
in entry 5, after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”
;
b
the first column (activity) in Table 2 (fees for assessments and reviews) is amended as follows—
i
in entry 1—
aa
after “Article 39(4)” insert “of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746”
;
bb
after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”
;
cc
at the end insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”
;
ii
at the end of entry 2 insert “of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746”
;
iii
at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746”
;
iv
in entry 5—
aa
after “Article 44(7)” insert “of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746”
;
bb
in sub-paragraph (b), after “Regulation (EU) 2017/745” insert “, or Regulation (EU) 2017/746”
.