Regulation 43 Amendment of the Market Surveillance (Northern Ireland) Regulations 2021

(1)

The Market Surveillance (Northern Ireland) Regulations 2021^f1 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”.

Annotations

Footnotes

f1: S.I. 2021/