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(1), other than solely by virtue of regulation 39(2) of those Regulations;
(b)it has been validated no more than 18 months before the test is administered.
(2) In this regulation “validated”, in relation to a device, means confirmed by—
(a)the Secretary of State;
(b)the National Institute for Health and Care Excellence(2); or
(c)a laboratory which is accredited by UKAS to ISO standard 15189(3) or ISO/IEC standard 17025(4), other than a laboratory which processes tests provided by the test provider or is owned by the test provider,
as having the levels of sensitivity and specificity stated by the manufacturer.
(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)“sensitivity”, in relation to a device, means how often the device correctly generates a positive result;
(c)“specificity”, in relation to a device, means how often the device correctly generates a negative result.
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.
A body corporate established under section 232 of the Health and Social Care Act 2012 (c. 7).
ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO 15189 Medical Laboratories requirements for quality and competence was published in November 2012.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories was published in November 2017.