PART 7Amendment of primary legislation
Investigatory powers under the Consumer Rights Act 2015I127
1
Schedule 5 to the Consumer Rights Act 20157(investigatory powers etc) is amended in accordance with this regulation.
2
In paragraph 8 (interpretation of Schedule 5), after the definition of “online interface order” insert—
“Regulation (EU) 2017/745 on medical devices” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
3
In paragraph 10 (enforcer’s legislation: duties and powers mentioned in paragraph 9(1)(a)) at the end insert “regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021”.
4
In paragraph 19 (exercise of powers in Part 4), in sub-paragraph (7A)(a)8, for the words from “a breach of” to the end substitute—
a breach of—
i
the Medical Devices Regulations 2002 (S.I. 2002/618),
ii
regulations made under section 15(1) of the Medicines and Medical Devices Act 2021,
iii
the Medical Devices (Northern Ireland Protocol) Regulations 2021, or
iv
Regulation (EU) 2017/745 on medical devices, and
5
In paragraph 30A9 (power to decommission or switch off fixed medical devices)—
a
in sub-paragraph (1), for the words from “pursuant to” to the end substitute—
pursuant to—
a
the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002 (S.I. 2002/618),
b
a duty in regulations made under section 15(1) of the Medicines and Medical Devices Act 2021, or
c
the duty in regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021.
b
in sub-paragraph (2), for “medical device to which the Medical Devices Regulations 2002 apply” substitute “relevant medical device”;
c
after sub-paragraph (2), insert—
3
In sub-paragraph (2), “relevant medical device” means—
a
where a domestic enforcer is acting pursuant to a duty mentioned in sub-paragraph (1)(a) or (b), any medical device to which the Medical Devices Regulations 2002 apply;
b
where a domestic enforcer is acting pursuant to the duty mentioned in sub-paragraph (1)(c), any medical device to which Regulation (EU) 2017/745 on medical devices applies.