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

Amendment to the Consumer Rights Act 2015

4.  In the Consumer Rights Act 2015(1), Schedule 5(2) (investigatory powers etc.) is amended as follows—

(a) in paragraph 8, after the definition of “Regulation (EU) 2017/745 on medical devices” insert—

““Regulation (EU) 2017/746 on in vitro diagnostic medical devices” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;”;

(b) in paragraph 19(7A)(a)—

(i) at the end of sub-paragraph (iii), omit “or”;

(ii) at the end of sub-paragraph (iv), omit “and” and insert—

“or

(v) Regulation (EU) 2017/746 on in vitro diagnostic medical devices, and”;

(c) in paragraph 30A(3)(b), after “Regulation (EU) 2017/745 on medical devices” insert “or Regulation (EU) 2017/746 on in vitro diagnostic medical devices”.

(1)

2015 c. 15.

(2)

Schedule 5 was amended by the Medicines and Medical Devices Act 2021, S.I. 2021/858 and S.I. 2021/905; there are other amending instruments but none is relevant.