Regulation 4 Test requirementsI1

England and Wales

(1)

Any device used for the purposes of an applicable test must meet the following requirements—

(a)

it can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002 M1, other than solely by virtue of regulation 39(2) of those Regulations;

F1(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F2(2)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)

In this regulation—

(a)

“device” means an in vitro diagnostic medical device within the meaning given in regulation 2(1) of the Medical Devices Regulations 2002;

F3(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4(c)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1: Reg. 4(1)(b) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(2) (with reg. 9)
F2: Reg. 4(2) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(3) (with reg. 9)
F3: Reg. 4(3)(b) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(4) (with reg. 9)
F4: Reg. 4(3)(c) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(4) (with reg. 9)

Marginal citations

M1: S.I. 2002/618, as amended by S.I. 2003/1697. Further amendments are prospectively made by S.I. 2019/791 with effect from 1st January 2021. There are other amending instruments not relevant to these Regulations.

Commencement

I1: Reg. 4 in force at 17.12.2020, see reg. 1(1)