Citation, commencement and application

1. —(1) These Regulations may be cited as the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 and come into force on the day after the day on which they are made.

(2) These Regulations apply to England only.

Interpretation

2. In these Regulations—

...

“ applicable test ” means a test to which regulation 3 applies;

“ diagnostic laboratory ” means an institution (or facility within an institution) which is equipped with apparatus and reagents for the performance of diagnostic tests for human infections;

“ operator of a diagnostic laboratory ” means the corporate body that operates the diagnostic laboratory, or if there is no such body, the director of the diagnostic laboratory;

“ point of care test ” means a diagnostic test which is not carried out in a diagnostic laboratory;

“ sample collection ” means the taking of, or assisting with or the supervision of the taking of, a physical sample from a person who is the subject of a test;

“ testing service provider ” means a person who carries out a sample collection or a point of care test, or a diagnostic laboratory.

...

...

Applicable tests

3. —(1) An applicable test is a test for the detection of coronavirus which is—

(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) provided , by or on behalf of a testing service provider, in the course of a business;

(c) not a test provided or administered under the National Health Service Act 2006 ;

(d) not a test provided by a person (P) solely to—

(i) P's employees;

(ii) persons contracted to provide services to P; or

(iii) both of the above; and

(da) not carried out using a device for self-testing.

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In this regulation—

(a) “ coronavirus ” means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

(aa) “ device for self-testing ” has the same meaning as in regulation 32(1) of the Medical Devices Regulations 2002.

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Test requirements

4. —(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, other than solely by virtue of regulation 39(2) of those Regulations;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provider requirements

5. —(1) A testing service provider must be accredited to the relevant ISO Standard by a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement in respect of any applicable test ....

(1A) The relevant ISO Standard for the purposes of paragraph (1) is—

(a) in relation to sample collection or a point of care test, ISO Standard 15189:2022 ;

(b) in relation to a diagnostic laboratory, either ISO Standard 15189:2022 or ISO/IEC Standard 17025:2017 .

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

UKAS accreditation

6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Offence and penalties

7. —(1) A testing service provider or an operator of a diagnostic laboratory commits an offence if, without reasonable excuse, they contravene a requirement imposed under regulation 4 or 5 ....

(2) An offence under this regulation is punishable on summary conviction by a fine.

Review

8. The Secretary of State must review the effectiveness of the provisions made by these Regulations before the expiry of the period of six months beginning with the day after the day on which they come into force.