Public Health, England Citation, commencement, extent, application and interpretation 1 1 These Regulations may be cited as the Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 and come into force on 1st January 2024. 2 These Regulations extend to England and Wales and apply to England only. 3 In these Regulations, “ the Principal Regulations ” means the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 . Amendment to the Principal Regulations 2 The Principal Regulations are amended in accordance with regulations 3 to 8. Amendment to regulation 2 3 1 Regulation 2 (interpretation) is amended as follows. 2 Omit the definitions of “administer”, “test provider” and “UKAS”. 3 After the definition of “applicable test” insert— “ 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. . Amendment to regulation 3 4 1 Regulation 3 (applicable tests) is amended as follows. 2 In paragraph (1)— a omit sub-paragraph (a); b in sub-paragraph (b) after “provided” insert “, by or on behalf of a testing service provider,” ; c after sub-paragraph (d) insert— da not carried out using a device for self-testing. ; d omit sub-paragraph (e). 3 In paragraph (2)— a after sub-paragraph (a) insert— aa “ device for self-testing ” has the same meaning as in regulation 32(1) of the Medical Devices Regulations 2002 . ; b omit sub-paragraph (b). Amendment to regulation 4 5 1 Regulation 4 (test requirements) is amended as follows. 2 In paragraph (1), omit sub-paragraph (b). 3 Omit paragraph (2). 4 In paragraph (3), omit sub-paragraphs (b) and (c). Amendment to regulation 5 6 1 Regulation 5 (provider requirements) is amended as follows. 2 In paragraph (1)— a for “test provider” substitute “testing service provider” ; b for “meet the following requirements” substitute “be accredited to the relevant ISO Standard by a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement” ; c omit “that they provide”. 3 After paragraph (1) insert— 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 . . 4 Omit paragraphs (2) to (7). Omission of regulation 6 7 Omit regulation 6 (UKAS accreditation). Amendment to regulation 7 8 1 Regulation 7 (offences and penalties) is amended as follows. 2 In paragraph (1)— a for “test provider” substitute “testing service provider or an operator of a diagnostic laboratory” ; b for “4,” insert “4 or” ; c omit “or 6”. Transitional provisions 9 1 A relevant person is not required to comply with regulation 5 of the Principal Regulations as amended by these Regulations until 6 December 2025 . 2 For the purposes of paragraph (1), a relevant person is a testing service provider who is accredited to either ISO 15189:2012 or both ISO Standards 15189:2012 and 22870:2016. 3 A relevant applicant is not required to comply with regulation 5 of the Principal Regulations as amended by these Regulations until the date calculated in accordance with regulation 6(6B)(b) of the Principal Regulations. 4 For the purposes of paragraph (3), a relevant applicant is a person who, prior to 1 January 2024, has made an application in accordance with regulation 6 of the Principal Regulations and is not yet accredited. Maria Caulfield Parliamentary Under Secretary of State Department of Health and Social Care 6th December 2023