PART 9Amendments of other secondary legislation
Amendment of the Market Surveillance (Northern Ireland) Regulations 202143
1
The Market Surveillance (Northern Ireland) Regulations 202117 are amended as follows.
2
In regulation 6 (enforcer’s legislation), at the end insert—
rr
regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021.
3
In Schedule 1 (investigatory powers)—
a
in paragraph 1 (interpretation of terms used in this schedule), at the end 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.
b
in paragraph 16 (power to decommission or switch off any medical device)—
i
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,
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(1) or (2) of the Medical Devices (Northern Ireland Protocol) Regulations 2021.
ii
in sub-paragraph (2), after “Medical Devices Regulations 2002” insert “or Regulation (EU) 2017/745 on medical devices”;
iii
in sub-paragraph (3)(a)(ii), after “Medicines and Medical Devices Act 2021;”, omit “and”;
iv
after sub-paragraph (3)(a)(ii) insert—
iii
the Medical Devices (Northern Ireland Protocol) Regulations 2021;
iv
Regulation (EU) 2017/745 on medical devices; and