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The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

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Amendment to Schedule 2 (fees in connection with the designation of notified bodies)

This section has no associated Explanatory Memorandum

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.

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