(This note is not part of the Regulations)
These Regulations amend the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 (S.I. 2020/1549) (“the Principal Regulations”) which establish a regulatory framework for providers offering COVID-19 testing services on a commercial basis in England.
Regulation 4 makes amendments to the types of test that are subject to the Principal Regulations.
Regulation 5 updates the test device requirements to bring the requirements into line with the Medical Devices Regulations 2002 (S.I. 2002/618).
Regulation 6 requires all testing service providers to be accredited to relevant ISO Standards, and reflects the publication of the updated ISO Standard 15189:2022. Regulation 7 revokes the existing process of applying for accreditation in three stages. Regulation 8 makes necessary updates to the enforcement provision.
Regulation 9 makes transitional provisions for those testing service providers who are accredited to the previous ISO Standards to enable them to continue to provide testing services while they transition to the updated ISO Standard, and for those testing service providers already progressing through the three-stage process of applying for accreditation to continue to provide testing services while they complete that process.
A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.