PART 4 Amendments to the Medical Devices (Northern Ireland Protocol) Regulations 2021

Amendment to regulation 19 (fees payable in connection with the designation of notified bodies)

39.  In regulation 19—

(a) in paragraph (2)—

(i) in sub-paragraph (a), after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;

(ii) in sub-paragraph (b), after “Article 44(10)” insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;

(iii) in sub-paragraph (c), after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;

(b) in paragraph (3) after “under Article 42” insert “of Regulation (EU) 2017/745”;

(c) in paragraph (8)(a), after “Article 42” insert “of Regulation (EU) 2017/745 or Article 38 of Regulation (EU) 2017/746”.