Regulation 18 Notified bodiesI1
United Kingdom
The Secretary of State is the appointed authority responsible for notified bodies under Article 35 F1of Regulation (EU) 2017/745 and Article 31 of Regulation (EU) 2017/746.
In the event of restriction, suspension, or withdrawal of a designation, the notified body must provide the Secretary of State with any documents requested for the purposes of enabling the Secretary of State to exercise the functions of the authority responsible for notified bodies under Article 46(6) F2of Regulation (EU) 2017/745 and Article 42(6) of Regulation (EU) 2017/746.
Annotations
Textual amendments
- F1
Words in reg. 18(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 38(a)
- F2
Words in reg. 18(2) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 38(b)
Commencement
- I1
Reg. 18 in force at 27.7.2021, see reg. 1(2)
Notes on Part 4
Textual amendments
- F1
Words in Pt. 4 heading inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 37