© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: email@example.com.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-industry-and-manufactures-covid-19-tests-and-testing-kits
The Department of Health and Social Care (DHSC) has issued a policy paper about the scaling up of coronavirus (COVID-19) testing programmes.
The MHRA is working with partners to support the delivery of the government’s agenda on COVID-19 testing. The UK Health Security Agency (UKHSA) have introduced new criteria for manufacturers seeking to place their tests on the market in the UK. This is known as COVID Testing Devices Authorisation (CTDA). All tests for COVID-19 must comply with the Medical Devices Regulations 2002 (as amended) and fulfil the requirements outlined here.
CTDA and Registering COVID-19 tests with MHRA
Under regulation 34A of the Medical Devices Regulations 2002 no antigen or molecular detection COVID-19 (SARS-CoV-2) test may be placed on the UK market without first being validated against minimum performance standards through a Coronavirus Test Device Approvals desktop review. Persons wishing to supply, put into service or place on the UK market a coronavirus test device, need to apply to the UK’s Health Security Agency (UKHSA) for approval.
Registration applications for covid test devices will not be accepted by the MHRA until the devices have received CTDA approval or are placed onto the Temporary Protocol list. Manufacturers of covid test devices are advised to seek CTDA approval from UKHSA prior to registering their covid test device with MHRA. If you believe your device is exempt from the regulation and wish to register it with MHRA, it is probable you will be contacted to specify the exemption applicable in The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 before your MHRA registration application is accepted.
Learn about how to apply for CTDA approval: COVID-19 test approval: how to apply - GOV.UK (www.gov.uk)
View COVID-19 test validation approved products here: Guidance overview: COVID-19 test validation approved products - GOV.UK (www.gov.uk)
For further information about CTDA, please contact firstname.lastname@example.org
You can apply to register your device with the MHRA when your device is compliant with The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
Target Product Profiles
Target Product Profiles (TPPs) have been developed to help manufacturers design and deliver tests that might be useful in delivering the UK testing strategy.
TPPs assist procurement decisions. Failure to meet the criteria set out in the TPP does not necessarily mean that a test doesn’t have wider applications for use in the UK.
TPPs are based on our best information, but the science is rapidly evolving. The TPP is subject to review and may need to be updated at short notice.
You can find more information about specific TPPs published by the MHRA at the following links:
For virus detection tests
For antibody detection tests
Actions for industry
Please read our guidance on how to help the government increase testing capacity.
If you think your antigen test meets the TPP, or if your test does not match the specifications of the TPP but looks promising, please consider submitting your proposal via the DHSC portal.
If you think your antibody test meets the TPP, or if your test does not match the specifications of the TPP but looks promising, please consider submitting your proposal via Dynamic Purchasing System (DPS) for antibody devices.
If you have enquiries regarding the supply of antibody test kits, email email@example.com.
If you have enquiries regarding the supply of antigen test kits, email firstname.lastname@example.org.
If you would like your antibody test kit to be independently evaluated using a “standardised test performance” process, please register your interest by following DHSC’s instructions.
If you have any enquiries regarding the independent evaluation of antibody tests, please email NIBSC@dhsc.gov.uk.
DHSC has a set process for the evaluation of diagnostic tests for COVID-19. If your test fulfils the DHSC evaluation process but does not yet have a UKCA, CE or CE UKNI mark, you can apply to us for a derogation. Please note that derogations will only be considered by the MHRA for COVID-19 products that are deemed critical for the National Testing Programme. The MHRA will require confirmation of this from the DHSC before any application is considered. If you do not have a UKCA, CE or CE UKNI mark, your test will only be able to be purchased and used once a derogation has been issued by the MHRA.
If you are not eligible to apply for a derogation, you will need to follow the process for applying a UKCA mark. We will continue to accept CE marked devices on the Great Britain market until 30 June 2023.
Please note that medical devices placed on the market in Northern Ireland must conform with the requirements of the UK Medical Device Regulations 2002 (as amended) (UK MDR 2002) until the In Vitro Diagnostic Medical Device Regulations (IVDR) (2017/746) fully applies on 26 May 2021.
More information on how to apply for a derogation can be found below.
Common terms related to COVID-19 testing
The MHRA has defined the terms in this section following requests from a range of stakeholders including manufacturers considering developing new COVID-19 rapid lateral flow tests during the COVID-19 pandemic.
The definitions below reflect MHRA’s current interpretation of these terms as they are relevant to the pandemic and COVID-19 testing only. The definitions are not transferable to other in vitro diagnostic testing scenarios.
A device (test) intended by the manufacturer to be able to be used by lay persons in a home environment. (Source In vitro Diagnostic Device Directive 98/79/EC Article 1).
The manufacturer of the self-test must demonstrate that they hold evidence to support the intended use as stated in their Instructions for use (IFU). For example if the self-test may be used by a lay person to help another lay person take the test, they must have evidence to support this use scenario.
UK MDR 2002 (as amended) requires self-tests to be reviewed by a third-party Approved Body before they can be UKCA marked. CE marked self-tests are reviewed by an EU Notified Body.
Professional use test
A test which is intended to be used by a professional user (see below).
The test must be UKCA marked or CE marked as a “general IVD” in accordance with UK MDR 2002 (as amended).
The manufacturer of the test must demonstrate that they hold evidence to support the intended use as stated in their Instructions for use (IFU) e.g. If the manufacturer of a professional use COVID-19 test intends the test to be used in an assisted or supervised testing situation, then the IFU should make this clear and there should also be evidence of performance data to support their use in these situations.
Assisted testing for COVID-19
A lay person is helped or supervised when collecting the sample for testing by a professional user (see below). The professional user performs the steps to obtain a test result.
The manufacturer of a COVID-19 professional use rapid lateral flow test which allows a lay person to collect their own swab sample must have supporting evidence demonstrating the test may be used in this way documented in the IFU.
It is acceptable for COVID-19 rapid lateral flow tests regulated as professional use tests and self-tests to be used in Assisted Testing Sites.
Supervised testing for COVID-19
A lay person is supervised by a professional user whilst the lay person performs the sample collection and operation of the COVID-19 professional use rapid lateral flow test.
The manufacturer of the professional use rapid lateral flow test being used under supervision must have supporting evidence demonstrating the test may be used in this way documented in the IFU.
The supervisor is a professional user (see below). The supervisor must be in the same location as the person taking the test. If required, the supervisor may conduct all or some of the steps to obtain a result.
The supervision may not be via video link or other telehealth approach unless the test being used is regulated as a self-test.
An individual who does not have formal training in a specific medical field or discipline (Source ISO 18113-1 section 3.34).
A person with no specific medical/clinical, scientific or technical knowledge relating to rapid lateral flow devices
A person who performs self-testing or self-swabbing without having a medical education
Professional Use and Professional User
Use by personnel who have received specialised education and training with regard to procedures utilising in-vitro diagnostic medical devices (Source ISO 18113-1 section 3.56).
Qualified healthcare professionals or laboratory personnel who in addition to their medical or laboratory qualifications have also received training and assessed for competency on the use of a specific in vitro diagnostic assay/test
An individual who has received comprehensive training and assessed for competency on the use of a specific point of care in vitro diagnostic assay/test such as the rapid lateral flow tests used by NHS Test and Trace at Assisted Testing Sites to detect cases of COVID-19 in asymptomatic individuals
Training and competency assessment
For information on what an appropriate training programme and competency assessment for professional users of COVID-19 tests should include, manufacturers and testing service providers should refer to the BSI Standards Publication PD ISO/TS 22583:2019 “Guidance for supervisors and operators of point of care testing (POCT) devices”. The MHRA recommends that there shall be an appointed person(s) (supervisor) who has the authority and takes responsibility for the quality of the service and is competent to supervise the testing and training of other professional users.
After completing the training programme professional users should
have demonstrated ability to apply knowledge and skills to produce an accurate POCT result
have an understanding of the testing requirements and be able to assess the appropriateness and suitability of the person to be tested
be able to perform tests following the manufacturers’ instructions for use, including quality control checks, operating environment and reagent storage
have an understanding of interference factors. For example, a substance or process which falsely alters a test result
be able to demonstrate safe and accurate results reporting and interpretation
have an understanding of quality assurance activities and be able to detect erroneous results and take appropriate action
The training should include a competency assessment to check for understanding and correct performance of the test.
Performance evaluation process for test kits
Test kit manufacturers are required to make claims about the expected performance of their test kit before they can place the test kit on the market in the UK.
These performance claims can include:
- analytical sensitivity
- diagnostic sensitivity
- analytical specificity
- diagnostic specificity
- reproducibility, including control of known relevant interference
- limits of detection
To make these claims, manufacturers must have adequate performance evaluation data supported by a reference measurement system (when available).
Manufacturers should include information on the reference methods, reference materials, known reference values, accuracy and measurement units used. Such data should originate from studies in a clinical or other appropriate environment or result from relevant biographical references.
Before a performance evaluation study can begin, devices for performance evaluation should be clearly identified and must be registered with us.
‘Device for performance evaluation’ means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate external environments.
In addition, the manufacturer must draw up a statement and submit to us, if requested.
The statement must contain the following information:
- data allowing identification of the device in question
- an evaluation plan stating the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned
- the list of laboratories or other institutions taking part in the evaluation study
- the start date and scheduled duration for the evaluations and, in the case of devices for self-testing, the location and number of lay persons involved, a statement that the device in question conforms to the requirements of the UK Medical Device Regulations 2002 (SI 2002 No 618) (as amended) (UK MDR 2002) (apart from the aspects covered by the evaluation and apart from those specifically itemized in the statement) and that every precaution has been taken to protect the health and safety of the patient, user and other persons.
More detail of how to carry out a clinical performance study is provided in BS ISO 20916:2019.
In addition, for devices for self-testing, we may ask for a manufacturer’s performance evaluation data as part of the registration for UKCA, CE or CE UKNI marking of the test.
The British Standards Institution have made their standards for In Vitro Diagnostic Medical Devices accessible and free of charge.
How to apply to MHRA for a derogation
Send your application to email@example.com
You should include the following information in your email:
- instructions for use/labelling plus relevant marketing material
- confirmation of the role of the applicant.
- a. legal manufacturer for the medical device
- b. if the manufacturer is outside of the UK, please provide details of their UK Responsible Person or Northern Ireland Authorised Representative (for applications for the Northern Ireland Market only).
- confirmation if this test is intended for the Great Britain market, Northern Ireland market or both
- the clinical evidence base – performance study report, other studies, literature etc. If you have not yet started your clinical performance study then please contact firstname.lastname@example.org.
- details of other regulatory approvals of the product within other jurisdictions e.g. FDA, etc.
- confirmation that you completed the DHSC evaluation process
- Post Market Surveillance Plan
- details of the product(s) (including model name, description and intended purpose of use)
- confirmation of the COVID-19 variants the test will detect
- reasons why the product does not have a valid UKCA, CE or CE UKNI mark
- an essential requirements checklist demonstrating how the device meets appropriate standards. Where standards are not met a rationale/plan should be provided.
- clinical justification for requesting an exemption from the regulations for the product
- explanation of any alternative products on the market and reasons why using these products would not be appropriate
- numbers of product likely to be supplied under the exemption, plus an indication of how widely used the product is
- expected time to gain/re-gain UKCA, CE or CE UKNI certification
- a detailed plan on how the manufacturer will demonstrate compliance or withdrawal of the device from the market after the temporary derogation expires.
You are expected to have evidence that the device performs as intended. For example, you should include performance data such as bench testing (including any that comply with a relevant standard – designated or other) and any study data you have.
We will be granting any exemptions under regulations 12(5), 26(3) and 39(2) of the UK MDR 2002.
Limited changes to use for medical devices
To create more flexibility for manufacturers and the availability of medical devices, we would not expect to receive a request for derogation of a UKCA, CE or CE UKNI-marked device where there is limited change to its intended use – for example, changing the use of a device from ward use to include intensive care use.
However, you should perform a risk assessment and contact your notified body for advice in the first instance.
What we will do with exemption applications
We might ask you for more information once we’ve received your application.
We expect to receive a high volume of applications for derogations.
We will prioritise applications based on the needs of the healthcare providers to increase the supply of critical devices and tests OR outputs from the DHSC evaluation process.