# The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023, Regulation 43: Amendment to Schedule 2 (fees in connection with the designation of notified bodies)


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”.

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Source: https://www.legislation.gov.uk/ukdsi/2023/9780348253696/regulation/43 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-43
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.