Closed consultation

Validation of COVID-19 tests: laboratory validation

Published 2 September 2021

Executive summary

Testing is an important part of the government’s strategy for managing COVID-19. The goal is to empower individuals to get tested, minimise community transmission and ultimately stop the virus in its tracks. Maintaining high performance of test products is key to achieving this.

There is evidence that a number of COVID-19 tests available on the UK market failed to replicate their stated performance in technical and in use validation and real-world evidence collection. Information about the true performance of COVID-19 test products is not easily accessible to consumers and this has left consumers without access to information that would allow them to make informed choices about the tests they purchase.

For these reasons, after consulting with the public and industry, the government has taken steps to introduce mandatory validation for COVID-19 tests. On 28 July 2021, it became a legal requirement for antigen and molecular COVID-19 detection tests to undergo validation (in the form of a desktop review) to assess their performance before being permitted for sale in the UK market.

We are now consulting on proposals to introduce further scrutiny on COVID-19 products on the UK market. The government proposes to introduce laboratory validation for COVID-19 test products under the Medicines and Medical Devices Act 2021. This would be in addition to desktop review and will involve independently testing the performance of a COVID-19 test product in a central laboratory against a specific set of criteria on behalf of the UK Health Security Agency (UKHSA). This will supplement the desktop review phase by helping to identify issues with poorly performing tests so that they can be removed from the market.

The consultation is open to everyone and will close on 30 September 2021.

Introduction

Testing will continue to form a crucial role in the response to COVID-19. We have seen growing availability of tests in the private market, and as this market grows, it is increasingly important that consumers have confidence that the COVID-19 detection tests they use give reliable and accurate results.

Coronavirus test device or COVID-19 test kit means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); medical devices and in vitro diagnostics (IVDs) such as COVID-19 tests kits, are goods or equipment intended for medical use.

The government has identified a market failure, which threatens to impact on the work to date in driving down levels of the virus. There is evidence that a number of COVID-19 tests available on the UK market failed to replicate their stated performance either in technical lab-based validation and when used in the real world. Information about the true performance of COVID-19 test products is not easily accessible and is often confusing and not comparable. This has left consumers and the public at large without access to information that would allow them to make informed choices about the tests they purchase and where they could be used.

The government established a validation process as it began the mass procurement and deployment of tests at the start of this pandemic. Three in four of the tests offered to the Department of Health and Social Care (DHSC) failed this validation process. However, all of these tests were CE marked, and could thus be legally sold to individuals and companies in the UK. This was recognised as a potential public health risk and a market failure.

Between 8 April and 5 May 2021, we consulted on proposals to introduce a UK mandatory validation regime for COVID-19 test products. As outlined in the government’s response to the consultation, we received over 40 responses from a broad range of stakeholders, including industry, academics and healthcare professionals. The responses were largely supportive of the policy including the laboratory validation. The proposals received widespread support from industry and private sector care-providers. Respondents agreed with the need to implement a minimum performance standard for COVID-19 tests available on the UK market and provide clarity for consumers on the tests they purchase. This sent out a clear signal that stakeholders support intervention to address the issues, by specifically pursuing a policy to introduce a requirement for the validation of COVID-19 tests.

After considering the responses to the original consultation, we decided to take steps to lay a statutory instrument under the Medicines and Medical Devices Act 2021 (MMDA) to create a regulatory requirement for the mandatory approval of antigen and molecular diagnostic tests for COVID-19. This legislation passed through Parliament and became a legal requirement on 28 July 2021.

The validation process regulates COVID-19 in vitro diagnostic devices as goods using reserved powers returning from the EU. It focuses solely on test device performance ‘out of the box’ and not any associated services that a company may provide. Testing service providers themselves are required to be accredited by the UK Accreditation Service (UKAS) to ISO standards through a separate process that is not covered here.

As outlined in the government’s response to the consultation published on 17 June 2021, the government has opted to deliver the validation regime for COVID-19 tests in 2 stages:

• desktop review – the government passed legislation which makes it a mandatory requirement for antigen and molecular COVID-19 detection tests intended for sale on the UK market to undergo a desktop review process. The desktop review involves scientific advisers reviewing supplier evidence against a set of performance criteria. It provides adequate assurances on the performance of COVID-19 test products on the market in the short term but not how they would perform in use

• laboratory validation – to further increase the scrutiny placed on COVID-19 test products, the government proposes to introduce an additional step of laboratory validation. We propose introducing a second statutory instrument (SI) to make laboratory validation a mandatory requirement, in addition to desktop review. Laboratory validation will involve independently testing the performance of a COVID-19 test product in a central laboratory against a specific set of criteria on behalf of UKHSA. This will further strengthen consumer confidence in COVID-19 detection devices by corroborating supplier desktop evidence. Further detail on what laboratory validation entails is outlined below

The desktop review has provided adequate assurances in the short term. However, the government proposes that the additional second stage of laboratory validation is an important step to providing the appropriate scrutiny on COVID-19 test products on the UK market and how they will perform in use. Testing is an important tool in responding to the pandemic and it is therefore necessary to give that extra level of assurances through laboratory validation.

We are now consulting on proposals to deliver the second stage of validation – laboratory validation. In this consultation, we are seeking views on:

• feedback on the first SI including desktop review

• laboratory validation and its future scope

• fees regime

• sensitivity and specificity thresholds

• sample types

• the regulatory environment (including EU regulation)

• the supply of COVID-19 tests, including trade flows

• safety, favourability and availability of COVID-19 tests

• whether in future legislation, the scope should be extended to other pathogen diagnostics

We have taken the decision to conduct a second consultation on the government’s proposals to introduce validation for COVID-19 tests. This is not a repeat of the first consultation and as set out above, we are seeking views on additional questions, while also seeking feedback on the introduction of stage 1 of validation to date.

The scope of this second SI will only apply to COVID-19 diagnostic tests and to goods regulation, however through this consultation will we are taking the opportunity to explore expanding the scope in future legislation to include other pathogen in vitro diagnostics.

A further public consultation on the future regulatory framework for medical devices will be published shortly by the Medicines and Healthcare products Regulatory Agency (MHRA).

Who can respond

This is a public consultation open to everyone. We are keen to obtain responses from businesses from all parts of the UK and internationally involved in the manufacture, distribution and retail of COVID-19 tests as both a good and a service as well as to users of the products. We are also keen to receive expert academic views and the views of health system partners such as NHS England and NHS Improvement and the NHS in general.

Copies of this consultation paper are being sent to:

• Association of British HealthTech Industries

• British In Vitro Diagnostics Association

• British Medical Association

• British Retail Consortium

• Make UK

• National Pharmacy Association

• Royal Pharmaceutical Society

Proposals

What the problem is we are looking to solve

Prior to the introduction of the new validation regime, entry into the SARS-CoV-2 (COVID-19) test product market was controlled by CE marking alone. The majority of COVID-19 detection tests fall under the General IVD (self-certified) category according to the current Medical Devices Regulations 2002 and the EU In Vitro Diagnostic Directive (98/79/EC). This means that manufacturers of self-certified devices will affix the CE marking to their devices, without any independent audit or conformity assessment from another body, either a UK approved body or an EU notified body. The performance declaration made as part of CE marking is not required to be independently verified ahead of sale and there was not a legally binding or consistent process for establishing the performance of COVID-19 tests.

The performance declaration made as part of CE marking is not required to be independently verified ahead of sale and there was not a legally binding or consistent process for establishing the performance of COVID-19 tests.

Evidence has shown that a significant number of COVID-19 tests have failed to replicate their stated performance for their intended use during independent validation and in real world use evaluation. During the validation process to inform DHSC procurement of lateral flow tests for example, we found that 75% failed at one stage or more. Overall, 277 molecular and antigen tests have been reviewed or validated by DHSC, of which only 58 have passed to the point where they could be considered for procurement.

Without intervention, underperforming COVID-19 tests would continue to be made available for purchase on the UK market, undermining national efforts to control the virus. The government feels that appropriate intervention is necessary to provide a legal recourse to remove products which either fail to replicate their stated performance, or which fail to meet a minimum bar which the government feels consumers should expect on these products. In addition, without government intervention consumers would be left without access to the information they need to make informed choices.

To address the issue, the government put forward proposals to introduce mandatory validation for COVID-19 tests by putting this on a legislative footing, as set out below.

The government is keen to encourage innovation and market growth while ensuring tests meet appropriate performance standards. It is important that consumers have confidence in the COVID-19 detection tests they use providing reliable and accurate results, wherever they are sold in the country and for whatever purpose across public and private sectors. By raising the expected performance of tests that are available on the market, legislation will stimulate manufacturer and supplier to develop or supply products that are market leading and fit for purpose. The government is keen to encourage innovation and expanded production, but not at the expense of test quality.

Step 1 – The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (made under the Medicines and Medical Devices Act 2021)

On 28 July 2021, the government made it a legal requirement to seek UK government validation for antigen and molecular COVID-19 detection in vitro diagnostic devices intended for sale on the UK market. This statutory instrument made it mandatory for COVID-19 test products to undergo desktop review. The territorial application of this instrument covers the entire United Kingdom.

The scope of the legislation covers mature existing technology, namely antigen detection and molecular detection technologies. These include:

• lateral flow tests for antigens

• loop mediated amplification tests (LAMP)

• polymerase chain reaction (PCR) tests

• antigen or molecular tests for point of care devices

The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (made under the Medicines and Medical Devices Act 2021) will ensure that COVID-19 detection test products available for purchase on the UK market meet a minimum performance standard and consumers can have confidence in the performance of the tests they purchase.

From 1 November 2021, no antigen or molecular coronavirus (SARS-CoV-2) detection test may be placed on the UK market without first being validated using a desktop review process against minimum performance standards by a UKHSA team. Anyone placing unvalidated test products on the market will face sanctions.

For test products already on the market, there is a transition period to ensure products are not removed unnecessarily. Suppliers of tests currently on the market must apply for validation by desktop review by 1 September 2021 and have passed this validation successfully by 31 October 2021 in order to continue selling their tests on the UK market. Those tests that do not pass the desktop review validation assessment will not be legal for sale in the UK from that point.

Enforcement

The government believes it is important that the appropriate powers are in place to ensure that any breach of regulations can be dealt with through appropriate penalties. Under the Medicines and Medical Devices Act 2021 (MMDA), compliance notices, suspension notices, safety notices and information notices can be served in respect of breaches (or suspected breaches) of the requirement and failure to comply with any of those notices is an offence.

Consumer information

The results of all tests that pass the desktop review validation process requirements will be published on a register on GOV.UK, alongside suitable test use-case related to the test performance characteristics. This will provide consumers with clear comparable data, making it easier to assess the performance and use-case of different tests on the market and make informed decisions when purchasing a test. There are currently no plans to publish a register of tests that fail validation.

Desktop review

The desktop review assesses the evidence a supplier submits against a minimum required data set. This step prevents products that are below the expected standards from progressing to the market as set out in the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021. The assessment is done in 3 steps:

• a scientific adviser reviews the evidence submitted

• the desktop review assurance group assesses the submission

• the regulatory approvals committee then considers it

You can find further guidance about how manufacturers or distributors can apply for the desktop review process on GOV.UK.

We are interested in understanding what impact the policy has had to date.

To what extent do you agree or disagree with the following statement: ‘I feel more confident in the quality of COVID-19 detection tests available on the market as a result of the introduction of mandatory validation’.

• strongly agree
• agree
• disagree
• strongly disagree
• I don’t know

To what extent do you agree or disagree with the following statement: ‘The UK’s mandatory validation regime for COVID-19 tests helps to make the UK safer in response to this pandemic’.

• strongly agree
• agree
• disagree
• strongly disagree
• I don’t know

Feedback on desktop review process

The portal for the validation process opened on the 28 July 2021. It allowed applicants to begin an application and return to it before finally submitting and paying the relevant fee. We have seen a high level of usage from both UK and overseas based companies and have supported applicants through direct engagement to their questions to the CDTA mailbox and with Question and Answer sessions with industry bodies.

If you have applied for validation, we are interested in understanding your experience so far. This includes your experiences of navigating the portal, making payments and interacting with scientific assessors.

Have you been involved in applying for validation for a coronavirus product?

• yes
• no

How would you rate your experience of applying for validation? (This question is on a scale of 1 to 10 with 1 being very poor and 10 being very positive)

Have you found the guidance clear and accessible?

• yes
• no
• I don’t know

Have you found the online portal easy to use? (maximum 250 words)

If you have any suggestions for improvement, please identify these here (maximum 250 words)

Proposal to introduce step 2 laboratory validation

The government proposes to make a second statutory instrument which will introduce mandatory laboratory validation, following desktop review for COVID-19 tests. We outline the government’s proposal below, including what laboratory validation would involve.

The new step of laboratory validation will add onto the existing desktop assessment and will be based on our experience to date of undertaking laboratory validation to inform use case and DHSC procurement decisions. This will mean when the legislation comes into force a coronavirus test device will need both a desktop validation approval and laboratory validation approval to access the UK market. At this point a test will need the following to enter the UK market:

• a CE marking followed by
• a validation approval following successfully passing desktop review followed by
• a validation approval following successfully passing laboratory testing

Just as a CE marking is a prerequisite for entering desktop review, the desktop review approval will be necessary in order to apply for laboratory validation.

What laboratory validation entails

Laboratory validation will take place by a UKHSA appointed central laboratory provider and will compare side-by-side the performance of the new test with that of a ‘gold-standard’ comparator molecular-based test. The validation tests are performed using a minimum set of samples from uninfected, asymptomatic and symptomatic individuals, to ensure representation of performance across a range of viral loads. Laboratory validation also looks at how sensitive the new test is to interference from other known pathogens and its lower limit for detection of coronavirus components. Following laboratory validation, should the new test meet the performance criteria, it will be given approval for sale in the UK.

This proposed second step of validation (laboratory validation) is intended to increase the scrutiny placed on test products and will likely remove further poorly performing tests from the market by identifying issues not recognised by the desktop review alone.

We will compare the performance of a product in laboratory validation with the performance claimed in the evidence submitted for the desktop review. If the laboratory validation demonstrates a different level of performance than the desktop review, we will make the approval decision based on the laboratory validation rather than the desktop review. If the laboratory validation and desktop review have consistent results, we will use the evidence from both to inform the approval decision.

Transition period

For those tests already holding validation approval following a successful desktop review when the legislation comes into force in December, we are proposing a 2-month grace period. For example, if new legislation were to come in to force on 1 December 2021, tests that pass desktop validation would have until 28 February 2022 to pass their laboratory validation. During this grace period tests with a desktop approval would remain legal for sale until 28 February 2022.

If a product has already been through validation

We recognise some laboratory validation may have already taken place for some test products on the UK market. Where our scientific advisers are satisfied the evidence presented in support of the test is of sufficiently high quality, we will rely on it to avoid any duplication and overly burdensome bureaucracy. We would still expect to conduct a laboratory validation of these test products but we would expect to potentially test fewer samples. This would ensure that the evidence claims from existing validation could be replicated in a laboratory setting to an appropriate degree. We believe that the proposed laboratory review will strengthen the already established desktop review process to create a strong, rigorous, and efficient validation process for COVID-19 detection tests. The government will evaluate the learning gained from this regulatory regime to help us produce world-leading best practice regulation and inform any other similar diagnostic test regulation.

We are interested in stakeholder feedback on the government’s proposals to introduce laboratory validation for COVID-19 tests, including;

• to what extent additional laboratory validation helps to meet the stated policy objectives (removing poor performing tests from the market, increasing consumer confidence in the performance of tests for the intended use case and helping consumers make informed choices) over and above desktop review

• the impact on investment and business planning decisions, including investing in the UK

Have you applied for validation (stage 1 desktop review)?

• yes
• no
• not applicable

If you answered no, please specify why you have decided not to apply for desktop review validation. (maximum 250 words)

Do you intend to apply for validation?

• yes
• no
• not applicable

If you answered no, please explain why you have made this decision. (maximum 250 words)

If applicable, will you apply for the second stage of laboratory validation if it becomes mandatory for selling on the UK market?

• yes
• no
• not applicable

If you answered no, please specify why not and outline how you would ensure your product performed in the defined use case and across a range of viral loads. (maximum 250 words)

If you answered no, can you confirm that you do not intend to sell your product on the UK market. (maximum 250 words)

In advance of applying for validation have you already, or intend to, improve your product?

• yes, I have already improved my product in advance of applying for validation
• yes, I intend to improve my product before applying for validation
• no, I won’t attempt to improve my product in advance of applying for validation
• no, I’m not applying for validation

Do you agree or disagree that mandatory validation of COVID-19 tests will discourage manufacturers from making iterative improvements to products to avoid the need to revalidate products?

• yes, I agree. Mandatory validation of COVID-19 tests will discourage manufacturers from making iterative improvements to products
• no, I disagree. Mandatory validation of COVID-19 tests will not discourage manufacturers from making iterative improvements to products
• I don’t know

How much would you calculate that you or your organisation has invested in addition to the validation fee in preparing for validation? Please specify what costs these include. (maximum 500 words)

Suppliers who wish to sell on the UK market must have already adapted to validation and many will have completed the first stage of validation by the end of the year. What do you think about a proposed nominal 2-month transition period?

• this period is too long
• this period is too short
• this period is appropriate
• I don’t know

Fees

Our ambition for this policy is to achieve full cost recovery for the validation process, so as not to burden the taxpayer, while also keeping fees as low as possible to encourage innovation and market growth.

Consequently, a payment is required for validation as part of the application process. Below is the table of current charges. They can vary depending on size of applicant’s company applying for validation.

Desktop validation fees

Service	Full price	Discounted price
Desktop review	£14,000	£6,200

We are unable to provide a refund if you cancel your application or your test does not meet our standards.

We recognise through our engagement with small business that fees could create a potential barrier that would prevent smaller players entering the market.

In response to this feedback, we have established a discount for small or medium size enterprises (SMEs), classed as entities comprising less than 250 employees, with the price set at £6,200 for the initial mandatory desktop review stage. 

This represents a total discount for SMEs of 55%, which is in line with taxation benefits for research and development spend offered to SMEs.

We propose maintaining the 55% discount for SMEs for the laboratory stage of validation. The proposed fees for full laboratory validation are set out in the table below.

Laboratory validation fees

Service	Full price	Discounted price
Laboratory validation	£75,000	£28,800

The total cost for desktop review plus laboratory validation for a non-SME would be £89,000, or £35,000 for an SME.

VAT is not chargeable for the validation process.

We recognise that significant validation has already been done on many of the test products subject to this legislation. Given the objective of achieving full cost recovery where previous evidence of validation can be relied upon, we will look to minimise the number of samples used in the laboratory validation process and work on a cost per sample basis.

In relation to the fees, we are interested in stakeholder feedback on the proposed level of fees and the proposed SME discount.

Do you agree or disagree that the 55% reduction in fees makes the validation process accessible for SMEs?

• I agree, the 55% reduction makes the validation more accessible for SMEs
• I disagree, the 55% reduction does not make the validation more accessible for SMEs
• I don’t know

Do you agree or disagree that a fee set between £75,000 (reduced to £28,800 for small or medium-sized enterprises) is reasonable for laboratory validation?

• I agree, the proposed fee seems reasonable
• I disagree, the proposed fee does not seem reasonable
• I don’t know

Do you agree or disagree that the fee for laboratory validation represents value for money in addition to the desktop review stage?

• I agree
• I disagree
• I don’t know

If you disagreed what would represent value for money? (maximum 250 words)

Sensitivity and specificity thresholds

Current thresholds

Minimum performance standards included in the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (made under the Medicines and Medical Devices Act 2021) are set out below.

Minimum performance standards are set out below by test type

Current sensitivity and specificity thresholds by test type

Requirement	PCR and isothermal (extracted)	PCR and isothermal (direct)	Antigen
Sensitivity	Lower limit of 2-sided 95% confidence interval entirely above 93%	Lower limit of 2-sided 95% confidence interval entirely above 70%	Lower limit of 2-sided 95% confidence interval entirely above 60%
Specificity	Lower limit of 2-sided 95% confidence interval entirely above 97%	Lower limit of 2-sided 95% confidence interval entirely above 93%	Lower limit of 2-sided 95% confidence interval entirely above 93%

Raising thresholds

It is already clear that industry is working hard to raise the quality of tests to surpass the thresholds set out in the first statutory instrument. Though avoiding false negatives is the most important aspect of the regulations due to the public health risk of someone unknowingly spreading the disease, reducing false positives is also highly important due to the impact on the individual and economy. This was reflected in the first SI thresholds for sensitivity and specificity.

In line with improving technology and the opening of society and economy, we propose that the specificities of both antigen and direct molecular tests are raised by 2 percentage points from 93% to 95% in both technologies.

Further improving test performance

The intention of the policy is help drive quality and support innovation by industry to do so. We recognise that test quality will improve as scientists refine existing tests, develop new techniques and discover new technologies.

We are keen to support the continual driving up of quality of tests. To this end, it has been suggested in previous feedback that an escalator could be used to ratchet up the thresholds at regular intervals. Implementing an escalator within the drafting of the statutory instrument would be a legal mechanism by which the thresholds could be automatically increased over time. This would also potentially create complex interaction with other parts of the regime that would need to be considered.

However, we believe the performance thresholds proposed for regulation above are already challenging, and there may be little scope for raising the thresholds for some of the test types. We would welcome views on the scope and need for changing the thresholds, and how we can incentivise continuous improvement in test performance.

Thresholds

Do you believe that the current thresholds set in legislation achieve the best medical outcomes? Or should they be increased particularly in relation to specificity as set out in this consultation document?

• the current thresholds should remain as they are
• the thresholds should be increased by at least the 2 points for specificity as proposed
• the thresholds should be lowered

Please explain your reasoning. (maximum 250 words)

How can we use the thresholds or other mechanisms to incentivise continuous improvement in test performance? (maximum 500 words)

Samples

All biological tests rely upon standardised means of capturing the material of interest. In the context of Coronavirus testing, a ‘sample’ normally refers to the material collected from the nose and/or throat by use of a cotton swab. This material is then extracted from the swab into a standard volume of aqueous solution for analysis. Contrived or surrogate samples are samples to which a known amount of the analyte of interest (in this case SARS-CoV-2 virus or some of its components) is added to mimic an infected sample. An example would be to add a known amount of virus to a nasal swab sample taken from a healthy individual. Contrived samples are often referred to as ‘spiked’ samples.

Current validation processes have included the use of both clinical and contrived samples. Wherever possible clinical samples that align with manufacturer’s instructions for use (IFU) will give the most accurate reflection of the product’s true performance in the intended use-case.

Clinical samples for validation are obtained via the existing testing pathway and the number of available appropriate samples is dependent on COVID-19 prevalence rates. Where prevalence rates are low, there will be a need to use contrived or surrogate samples validation. CTDA laboratory validations will endeavour to use contrived samples that are reflective of the IFU samples requirements.

As more people are vaccinated and the prevalence of the virus declines, the ability to harvest natural samples from voluntary donations by infected persons will decline. As such to offset this and provide a sustainable supply of samples at the volumes required for validation process, contrived samples may be required. Contrived samples are artificially produced by spiking uninfected samples with the virus. These contrived samples may call for different thresholds to those for samples from individuals account for artificial creation. As such, a higher threshold may be required for those tests validated with contrived samples.

We are interested in your feedback on the use of samples during validation.

Based on your expertise, do you think that validation thresholds will need to change if we move from live samples to a mixed model including contrived samples? (maximum 250 words)

Do you agree with the use of contrived samples or materials being used to validate COVID-19 test kits? If you disagree please provide a reason. (maximum 250 words)

Should contrived samples use different thresholds for validation to those set out already? (maximum 250 words)

Product lifecycle

We are interested in understanding more about the lifecycle of COVID-19 test products and how this compares to other diagnostic devices.

The nature of the pandemic has seen many COVID-19 tests brought to market rapidly over the past 18 months. Further due to the extraordinary nature of the pandemic, the rate of innovation has far exceeded that usually seen in diagnostic devices.

Coronavirus will remain as an endemic condition and we anticipate that testing kits will still be needed for years to come, although in much lower numbers.

In the first statutory instrument we took the decision to use the standard 5-year time frame as the approval period, which mirrors the approval period used for most other medical devices. However, it has been suggested this could create a disincentive to innovate and that at least for the duration of the pandemic, a much shorter time frame would be more suitable.

We are interested in finding out your views on this, including the current 5-year approval period.

Within the current legislation introducing validation for COVID-19 tests, once a product is validated, the approval lasts for 5 years if the product remains unchanged. Do you feel this is an appropriate length of time?

• yes, this is an appropriate length of time
• no, the approval time should be longer
• no, the approval time should be shorter

Please explain your reasoning. (maximum 250 words)

In your opinion, how often are COVID-19 test devices updated or modified? (maximum 250 words)

How does this compare to in vitro diagnostic devices for other conditions? (maximum 250 words)

Ongoing monitoring

Currently the validation process will begin and end as suppliers apply for entry to the UK market. There will be an assumption that ongoing quality will be maintained. Actions by suppliers that would invalidate their approval to market would be dealt with via MHRA and trading standards enforcement. We have received feedback that has suggested some level of ongoing batch monitoring would be suitable, however that would increase fees levied on applicants.

Thinking about how we monitor products for quality and performance in the longer-term, do you agree or disagree that ‘there should be more assurance over monitoring and ongoing performance of COVID-19 tests, above and beyond the validation system proposed’?

• yes, I agree. There should be more assurance over monitoring and ongoing performance of COVID-19 tests, above and beyond the validation system proposed
• no, I disagree. There should not be more assurance over monitoring and ongoing performance of COVID-19 tests, above and beyond the validation system proposed
• I don’t know

If you answered yes, how would you see this being implemented? (maximum 250 words)

Consumer information

Central to this policy has been empowering consumers with clear comparable information on which they can base their purchasing decisions. The first SI established that there would be a register of COVID-19 tests.

The register will not be published until the first product has passed desktop review. The register will show all those products that have passed validation and are thus fit for sale on the UK market. The register could also allocate each test device to a recommended use case (for example, workplace screening, public health screening or clinical diagnostic testing) based on the sensitivity and specificity thresholds set out in guidance, and include advice on use, such as whether repeat screening would be advisable when using that device. Currently the government does not publish results regarding tests that failed validation.

We are interested in your feedback on this approach, including publishing the government’s recommended use alongside tests on the register, and whether there is anything additional government could do to help consumers make informed choices when purchasing COVID-19 test products.

Do you agree or disagree that government should publish a list of products that have failed validation to help consumers identify tests that are not fit for purpose?

• I agree, government should publish a list of products that have failed validation
• I disagree, government should not publish a list of products that have failed validation
• I don’t know

Is there anything additional government could do to signal the validation scheme to consumers? For example, labelling, advertising, manner of sale requirements. (maximum 250 words)

Expanding the scope of future legislation (other COVID-19 detection test technologies, multiplex tests and tests for other pathogens)

The tests currently in scope for the legislation introducing mandatory laboratory validation cover the mature existing technology, namely antigen detection and molecular detection technologies specifically for COVID-19. The most well-known examples include:

• lateral flow tests for antigens
• loop mediated amplification tests (LAMP)
• polymerase chain reaction (PCR) tests
• antigen or molecular tests for point of care devices

The rationale for limiting the scope of this policy to cover mature COVID-19 detection test technology was to ensure that regulation would cover the majority of COVID-19 tests available on the market in response to the challenge of this pandemic. This was based on the principles that:

• first, in order to have a well-functioning validation system, the government must be confident that we have an appropriate validation mechanism to test the performance of those tests

• second, the government wants to ensure that new regulation does not stifle innovation. However, we do want to prevent poorly performing tests from being sold, whatever technology they use

We are aware that there are some COVID-19 technologies and multiplexing tests incorporating COVID-19 targets that are out of scope and will not appear on the register and as such consumers may misinterpret this to mean they are not fit for sale or are fit for use in terms of performance.

As such, bringing them within scope of validation even using alternative testing protocols or just undergoing a desktop assessment may be appropriate so that the register is a holistic list of all tests consumers may want to buy rather than the limited range of technologies currently covered. There are also a broader set of diagnostic tests for other pathogens that will be important to consider as we move to preparing for the future under UKHSA.

Looking ahead, we are interested in what industry, the public and the broader health and care system and other partner organisations think about expanding the scope of validation to cover other technologies being developed:

• to detect coronavirus infection using other technologies not currently covered
• to detect coronavirus infection and other respiratory viruses together
• to detect other pathogens that will be important in emergency preparedness planning and responding to public health issues

Currently mandatory validation of COVID-19 tests only covers antigen and molecular detection test technology. Do you agree or disagree that all COVID-19 tests should be in scope and therefore subject to mandatory validation to be permitted for sale on the UK market?

• yes, I agree all COVID-19 tests should be in scope
• no, I disagree
• I don’t know

If most testing technologies were covered, are there any you would recommend be specifically excluded from validation? Please explain your reasoning. (maximum 250 words)

Are there any specific COVID-19 detection tests or test technology that is not currently within scope of the legislation which you believe should also be subject to mandatory validation?

• Yes
• no
• I don’t know

If you answered yes, please give your reasons. (maximum 250 words)

Other pathogen diagnostics

We are also interested in understanding more about the public and industry’s appetite for extension of the validation model of regulation to other pathogen diagnostic tests. Pathogens refers to any organism that has the potential to cause infectious diseases in its host. Bacteria, viruses, fungi and parasites are all common types of pathogens that can cause pathogenic, or infectious, diseases. For example, influenza, measles, and HIV are all types of pathogenic diseases.

The establishment of UKHSA marks a change in the way we approach health protection. We want to ensure the UK is ready to respond to the challenges of the future and in doing so, to consider new ways we can prevent and respond to external health threats such as infectious diseases. We expect future public health threats from a range of sources where reliance on early diagnosis and disease management will be critical to contain and control outbreaks before they become national epidemics. This becomes more pressing with evolution of viral, fungal and bacterial infections resistant to current treatment regimes. There are new potential pandemic threats emerging all the time, for example, Candida auris is a serious global health threat. It is an emerging fungal disease, which presents similar symptoms to COVID-19 symptoms in patients.^{[footnote 1]} Early detection can prevent outbreaks, however the disease is difficult to identify with standard laboratory methods. We must remain ahead of the curve and globally vigilant for mutations of any pathogen that would increase its transmissibility making it a pandemic threat.

We have the opportunity to be more innovative in the way we approach pathogen diagnostics for all kinds of infectious diseases. Driving up the standards of pathogen diagnostics tests through similar validation regulation could be one way of doing this.

In considering tests and technologies for other pathogens associated with reportable infectious diseases, do you agree or disagree that the government should expand the scope of mandatory validation?

• yes, I agree the government should expand the scope of mandatory validation to tests for other pathogens associated with reportable infectious diseases
• no, I disagree the government should not expand the scope of mandatory validation to tests for other pathogens associated with reportable infectious diseases
• I don’t know

If you answered yes, what tests and/or technologies should mandatory validation focus on, recognising this needs a broader set of discussions? (maximum 250 words)

If you answered no, give your reasons. (maximum 250 words)

Antibody tests

Antibody tests are used to detect antibodies that a person has developed against the virus that causes COVID-19. Antibodies can be developed after a previous infection by the virus or vaccination. Antibody testing is helping us to understand more about the virus and new variants, including information about vaccine effectiveness.

While such tests are currently available to purchase on the UK market, they are not within scope of the existing validation legislation.

Antibody testing differs from virus testing. Virus testing can tell someone whether they currently have the virus, whereas antibody testing detects antibodies that are produced after previous infection or vaccination.

We are still learning about the body’s immune response to the virus. Recent studies suggest that individuals who have been infected may have immunity from symptomatic disease for at least 7 months. It is almost certain that someone with antibodies, either from a past infection or vaccination, will be protected from severe disease in most cases, but new variants may alter risk. However, we are still uncertain as to whether having antibodies means you cannot transmit the virus to others.

Antibody testing should not be used to provide a person with information that would cause them to change their behaviour. Conversely, the results of a virus should be used to inform people about whether they need to change their behaviour, for example to self-isolate if they have a positive test result.

Currently, antibody tests need only be CE or UKCA marked and manufacturers established in the UK must be registered with the MHRA.

NHS Test and Trace currently use a simplified standardised evaluation process to short list antibody products for potential consideration for antibody testing. The current process allows for antibody testing assays to be benchmarked and is a process for the department, set up to gather information on new assays, to give consistency in evaluation and to relieve the demand on Public Health England (PHE).

Financial liability for the preliminary and assay evaluation stages lies with the manufacturer. For the independent evaluation by PHE, the manufacturer pays for equipment and training supplied to PHE, and PHE will invoice DHSC for its costs.

The current process involves manufacturers running tests on their assays in 2 stages, using a common validation and if successful, using verification panel supplied by National Institute for Biological Standards and Control (NIBSC) and self-reporting the results. Reports are issued by NIBSC and a Test and Trace appointed Results Oversight Committee evaluate these. If results from the 2 stages are approved, PHE then perform usability evaluations using supplies from the manufacturer, reporting for evaluation by the Results Oversight Committee. If the results are satisfactory, the Technologies Validation Group (TVG) endorses these results and they are published on GOV.UK.

There is now an opportunity to bring COVID-19 antibody tests into the same regulatory arrangement as the current and proposed validation arrangements for COVID-19 virus tests.

The current evaluation process for COVID-19 antibody tests in the UK is voluntary and only required for manufacturers registering their interests in working with the government. Other antibody tests need only be CE or UKCA marked and MHRA registered. Should the process be altered and legislatively underpinned, as set out in this consultation in relation to other testing, or should it remain voluntary?

• validation for COVID-19 antibody testing should remain voluntary
• validation for COVID-19 antibody testing should become mandatory
• I don’t know

Multiplex tests

Multiplex tests are tests that check for genetic material produced by viruses that cause several different respiratory infections. For example, a multiplex test might test for both COVID-19 and influenza.

Currently the legislation stipulates that mandatory validation applies to multiplex tests (tests that simultaneously detect other pathogens alongside SARS-CoV-2), but that only the COVID-19 detection part of the test will be validated for its performance.

We are interested in gathering views on whether industry and the public think multiplex tests should be validated for all viruses included within the test, or alternatively, if there is anything additional government could do to clarify which parts of a multiplex test have been validated for their performance.

Do you agree or disagree that government should expand the scope of validation to cover the other pathogens detected by multiplex tests?

• yes, I agree. The government should expand the scope of validation to cover multiplex tests
• no, I disagree. The government should not expand the scope of validation to cover multiplex tests
• I don’t know

If a multiplex or multipathogen tests which includes a test for COVID-19 is validated by DHSC, as a consumer, would you expect that that validation had approved the performance of both or all infectious diseases detected by the multiplex test, or just the COVID-19 detection element?

• yes, I would expect that validation had approved the performance for all diseases on the multiplex test
• no, I would expect that validation had approved just the COVID test on the multiplex test

If you answered yes, what can government do to communicate this better? (maximum 250 words)

Regulatory environment

Medical devices and in vitro diagnostics (IVDs) are goods or equipment intended for medical use. Examples of the broader range of medical devices include high-risk devices such as coronary stents and neurostimulators to low-risk devices such as reading glasses and plasters. The IVD market is equally broad covering products such as pregnancy tests and COVID-19 tests.  

Medical device regulation is overseen by the MHRA. Products come to market via 2 key pathways:

• self-certification for low-risk devices
• Approved Body conformity assessment for all other products

The Approved Body assessment is independent from the MHRA. The affixing of a UK or EU Conformity Assessment mark (UKCA and CE, respectively) means the manufacturer has the evidence to demonstrate the safety and performance of the device.

Due to the market failure coupled with the pressing public health threat of the pandemic and the specific issues that we seek to address in this consultation have led to quicker and more innovative approaches to regulatory intervention. This has been enabled by the restoration of regulatory powers over goods provided by our exit from the EU.

We have developed policy, brought online delivery and placed into law new product regulation in under 6 months to protect public health. Though the EU has recognised the same issue as we did, and that it requires addressing, it will not take any action until May 2022 at the earliest.

DHSC brought together scientists with economists and ‘better regulation’ specialists to develop the best approach to new regulation. As such our regulation is both more rigorous, requiring higher standards than the comparative EU regulations will, and more agile.

As we move forward to chart our own course on medical devices regulation, work in this policy area will correspond with our wide-ranging diagnostic strategy, in which we are keen to assess what lessons can be learned from this experience and potentially be used as a model for combating other infectious diseases. By ensuring that a legacy is left in diagnostics after the pandemic, we can lessen the possibility of a national health risk and subsequent security issue.

We are interested in gathering views on what lessons from this regulation you believe government should consider going forward. Particularly in regard to improving the sensitivity and specificity of diagnostics for other pathogens.

To what extent should COVID-19 validation regulation serve as a model for other pathogens? (maximum 250 words)

Would other pathogen diagnostic tests benefit from a publicly available register with clear comparable data for consumers?

• yes
• no

Exemptions

A number of exemptions currently exist. These were put in place to ensure no practical issues emerged in the supply of tests through DHSC or devolved administrations, or to NHS hospitals where they had procured directly, while the new regulatory validation process began.

DHSC procures for the whole UK on behalf of the devolved administrations as well as for NHS and other public sector bodies for defined products. It already uses an equivalent validation process, managed by the Technologies Validation Group (TVG) and the Lateral Flow Validation Group (LVG) to inform procurement decisions. It would be duplicative and unnecessary for DHSC as regulator to regulate itself. However, once enough tests have been through CTDA approval and authorisation, the rationale for DHSC running a validation process to inform procurement decisions may recede.

The exemption for existing NHS contracts was introduced to avoid potential continuity of supply issues for NHS organisations that have procured tests direct from suppliers. The current exemption remains in place for those tests for the duration of the supply contract.

Tests procured direct by NHS organisations through new supply contracts must be approved through the new regulatory validation process.

We would value your views on this including any impact that it may have to service delivery.

Do you agree or disagree that the exemption for tests DHSC and the devolved administrations place into service (for example Test and Trace provided kits) should remain in the legislation?

• yes, I agree
• no, I disagree
• I don’t know

Do you agree or disagree that the exemption for DHSC and devolved administrations procurement should remain in the legislation?

• yes, I agree
• no, I disagree
• I don’t know

Please explain your reasoning. (maximum 250 words)

Do you agree or disagree that the exemption for NHS trusts and procurement pursuant to pre-existing contracts should remain in the legislation?

• yes, I agree
• no, I disagree
• I don’t know

Please explain your reasoning. (maximum 250 words)

If the exemption for NHS trusts was removed, do you foresee any issues with service delivery?

• yes
• no
• I don’t know

Please explain your reasoning.

Northern Ireland

Under the Northern Ireland Protocol, medical devices, including COVID-19 test kits must comply with EU rules. The EU In Vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) will take effect in Northern Ireland from 26 May 2022.

As set out in its 21 July 2021 command paper on the Northern Ireland Protocol, the government is seeking a new balance on the Protocol. The government has proposed a dual regulatory regime for manufactured goods, which would allow medical devices made to either UK or EU rules to be placed on the market in Northern Ireland, including COVID-19 test kits. This is in order to ensure that consumers in Northern Ireland do not face barriers in accessing goods from Great Britain, and would enable test kits made to UK rules to circulate and be placed on the market in Northern Ireland.

The new EU regime for COVID-19 tests will rely on a different approach to ensuring product safety. These will be set out in EU legislation and will require manufacturers to use third party Notified Bodies (independent testing bodies, accredited as competent to test to the relevant rules) before the COVID-19 tests can be placed on the EU market, as well as in Northern Ireland. The manufacturer of a UK validated test would need to seek third party conformity assessment either by a UK Notified Body, which would allow that product to be sold in Northern Ireland (but not the EU) or a EU Notified Body which would allow that product to be sold in the EU and in Northern Ireland.

In the absence of the dual regulatory regime proposed by the government in its July 2021 command paper, and in line with the existing operating arrangements under the Protocol, there would be the potential for challenges to the supply of COVID-19 test kits if manufacturers did not seek to meet these additional requirements in order to supply the Northern Ireland market. The government would need to monitor any implications and consider any further required steps in such a scenario.

In line with the government’s commitments to Northern Ireland’s unfettered access to the rest of the UK internal market, under existing legislation COVID-19 tests placed on the market in Northern Ireland can also be placed on the market in the rest of the UK. This position would be kept under review with respect to any implications or risks for goods being placed on the market in Great Britain.

What would be the potential issues arising if manufacturers of UK validated COVID-19 tests were required to meet any additional or different requirements under the Northern Ireland Protocol to supply tests to the Northern Ireland Market, in the absence of a dual regulatory regime in line with the government’s command paper proposals? (maximum 500 words)

What would be the anticipated consequences of this on the supply of COVID-19 tests to Northern Ireland? (maximum 250 words)

Safety, favourability and availability of COVID-19 tests

The Secretary of State’s overarching objective in making regulations under section 15 of the Medicines and Medical Devices Act 2021 to give effect to the policy outlined in this consultation document is to safeguard public health.

In considering this policy and the regulations which may be needed to give effect to it, the Secretary of State has had regard to the following matters:

• the safety of medical devices within the scope of this policy
• the availability of medical devices within the scope of this policy
• whether the United Kingdom is likely to be seen as a favourable place in which to: research the medical devices within the scope of this policy, develop medical devices within the scope of this policy or manufacture or supply medical devices that come within the scope of this policy

The Secretary of State’s assessment was published in the government’s response to the consultation, included in annex A (below).

We are seeking further feedback from stakeholders on their views regarding the safety and availability of COVID-19 tests and medical devices, as well as the favourability of the UK as a place to research, develop and manufacture or supply COVID-19 tests, particularly in relation to the introduction of the additional stage of laboratory validation.

During the consultation held between 8 April to 5 May 2021, we asked respondents to consider the above. Below are some of the key findings from the first consultation:

• availability – over 70% of respondents who answered the question agreed that the proposal would not restrict the supply of high quality COVID-19 tests

• safety – the safety of COVID-19 medical devices themselves was not highlighted as a concern by respondents to the consultation. However, many respondents commented on the indirect risk that poor performing COVID-19 tests pose to public health. Reducing the risk of false positives and false negative results was seen very favourably for public health and the economy

• favourability – when asked about whether the proposals would impact the UK’s favourability to research, develop or manufacture COVID-19 tests, there was a mixed response. Similar to the concerns raised regarding the supply of tests, respondents raised the issue of additional demands on manufacturers and concerns about the potential to impact innovation. A few highlighted concerns that the UK could be seen as a less favourable market due to the additional financial and administrative demands

We are interested to understand what people think about the impact upon availability, safety and favourability of the UK, based on proposals to introduce the second stage of laboratory validation.

Safety

On the basis that under current proposals COVID-19 tests would be required to undergo additional laboratory validation to sell on the UK market, do you agree or disagree that these proposals will have a positive impact upon patient safety?

• I agree, additional laboratory validation for COVID-19 detection tests will positively impact upon patient safety
• I disagree, additional laboratory validation for COVID-19 detection tests will not have a positive impact upon patient safety
• I don’t know

Please explain your reasoning. (maximum 250 words)

Favourability

On the basis that under current proposals COVID-19 tests would be required to undergo additional laboratory validation to sell on the UK market, do you agree or disagree that the United Kingdom is likely to be seen as a favourable place in which to research, manufacture, develop or supply COVID-19 detection tests?

• I agree, additional laboratory validation for COVID-19 detection tests will positively impact upon the favourability of the UK as a place to research, manufacture or develop COVID-19 detection tests
• I disagree, additional laboratory validation for COVID-19 detection tests will not have a positive impact upon the favourability of the UK to research, manufacture or develop COVID-19 tests
• I don’t know

Please explain your reasoning. (maximum 250 words)

Availability

Under current proposals COVID-19 tests would be required to undergo laboratory validation to sell on the UK market. Do you agree or disagree that the policy will have a positive impact upon the availability of COVID-19 detection tests in the UK?

• I agree, additional laboratory validation for COVID-19 detection tests will have a positive impact upon the availability of COVID-19 detection tests
• I disagree, additional laboratory validation will have a negative impact upon the availability of COVID-19 detection tests in the UK
• I don’t know

Please explain your reasoning. (maximum 250 words)

Innovation

The UK government is keen to leverage the UK’s capabilities as a global centre for innovation, to drive up test quality, and drive down test prices. During the previous consultation, some stakeholders raised concerns that validation could have a detrimental impact upon innovation. We are interested in gathering your feedback on this issue.

Do you think that the introduction of additional mandatory laboratory validation for COVID-19 tests positively or negatively impacts innovation in this diagnostics sector?

• positively impacts upon innovation
• negatively impacts upon innovation
• I don’t know

Please explain your reasoning. (maximum 250 words)

Do you think expanding the scope of validation to cover other COVID-19 tests (for example antibody tests) or for other pathogens would have a positive or negative impact on innovation?

• positively impacts innovation
• negatively impacts innovation
• I don’t know

Please explain your reasoning. (maximum 250 words)

Are there any changes to regulation that could be made to increase its support for innovation without decreases its safeguards for consumers? (maximum 250 words)

Trade flows

We are interested in understanding more about the flow of COVID-19 test products in and out of the UK. The questions set out below are targeted at those involved in manufacturing, purchasing or selling COVID-19 tests.

If you import COVID-19 tests, can you identify which ports your products enter through? (maximum 250 words)

If you export COVID-19 test products, can you identify which ports your products are exported through? (maximum 250 words)

Which countries do you import or export COVID-19 products from or to? (maximum 250 words)

If you are manufacturing in the UK, where are your manufacturing centres? (maximum 250 words)

International market

The UK has long been seen as centre of excellence in high quality regulation which first and foremost protects consumers. This reputation has extended to many British goods sold internationally which have a reputation for high quality. We have received feedback that suggests in many parts of the world a test that has been seen to pass British regulatory standards will be seen as a trustworthy test and as such could act as an incentive to consumers particularly when coupled with the register information available online.

Would you see passing the UK’s validation for COVID-19 tests as a helpful marketing tool for selling in other international markets?

• yes, it would be a helpful marketing tool for selling in other markets
• no, it would not be a helpful marketing tool for selling in other markets
• I don’t know

COVID-19 detection test product market

We are interested in gathering evidence in relation to the market. The UK market has grown exponentially since the beginning of the pandemic. As this is a fast evolving market we are keen to gain as much insight as possible to better tailor our regulation and to measure its impacts. The questions set out below seeks to address this.

If you have responded or intend to respond to the call for evidence you may wish to summarise your answers from that response or indicate that you have addressed them in that response.

What would you estimate the current size of the UK COVID-19 market is? (maximum 250 words)

What would you estimate is the average gross profit margin of a test device manufacturer? Gross profit margin is the product revenue minus the cost of sales divided by revenue. Please explain what elements you are including in the cost of sales, for example, fixed costs, research and development spending, branding. (maximum 250 words)

What is the average unit production cost for COVID-19 tests? Please state which technology you are referring to. (maximum 250 words)

What is the average development cost for developing a new COVID-19 test? Please state which technology you are referring to. (maximum 250 words)

What would you consider to be a fair price for a COVID-19 test? (maximum 100 words)

Consumer behaviour

A key strand of the policy is to empower consumer choice via information. This is why the regulation creates the register providing clear comparable data of how tests perform in different use cases. By addressing the market failure of confusing information, the market should more efficiently allocate resources (tests) to the consumers to maximise their utility.

Do you agree or disagree that laboratory validation will add significant value to consumers, by improving their ability to compare test products and assuring them on the quality and performance of tests?

• yes, I agree
• no, I disagree
• I don’t know

Business behaviour

It is important that as well as building an understanding of the market as a whole, we understand the behaviour of individual players within it. As the private sector takes on more of a role, we want to ensure regulation facilitates best business practice while protecting consumers. To do this we need to understand the drivers that underpin behaviour of manufacturers, distributors and retailers participating in the market.

To this end, the next set of questions seek answers to build these behavioural models on, by assessing what impact you believe the validation regulation to date has had on the behaviour of individual players within the market, or thinking as a supplier, whether the validation policy has had any impact on your behaviour within the market. This will help us refine existing and future regulation.

These questions are for manufacturers and distributors of tests.

Has the introduction of the UK validation scheme stopped you from investing or selling in the UK market?

• yes
• no

If yes, please provide an explanation. (maximum 250 words)

Do you agree or disagree with the statement: ‘the UK’s validation system makes the UK a less desirable place to sell COVID-19 tests’?

• strongly agree
• agree
• disagree
• strongly disagree
• I don’t know

If your product failed validation, would you likely make improvements and reapply or choose to no longer sell that product in the UK?

• make improvements and reapply
• choose to longer sell that product in the UK
• not applicable

Please explain your reasoning. (maximum 250 words)

Next steps

Following the closure of the consultation period on 30 September 2021, DHSC will analyse the responses. If the decision is taken to introduce a second laboratory review stage to the mandatory validation process, we expect to move quickly towards laying secondary legislation. The UK government response to this consultation will follow in due course.

As a COVID-19 test is a medical device used for diagnosis, the UK government proposes using the Medicines and Medical Devices Act 2021 (MMDA) to amend the Medical Devices Regulations 2002. The amending regulations would establish a mandatory second stage of the validation process, which will require manufacturers of COVID-19 tests to apply for independent validation of the performance of their tests, via desktop review and laboratory review, for these to be placed on the UK market.

This will place a legal duty on manufacturers to put their COVID-19 tests through the 2-stage validation process before placing them on the UK market. It would be a criminal offence for manufacturers, vendors or distributors to sell unvalidated tests.

We intend to keep the regulatory regime under review and engage continually with stakeholders to reform it as necessary in response to feedback. We believe this flexible approach will keep the regulation sufficiently agile to respond to evolution in the market while ensuring high standards are maintained continuously.

Annex A: summary of the Secretary of State’s assessment of the matters set out in section 15 of the Medicines and Medical Devices Act 2021

Below is the Secretary of State’s assessment of the matters set out in Section 15 of the MMDA set out in the government’s response to the consultation held earlier this year:

“The Secretary of State’s overarching objective in making any regulations under section 15 of the Medicines and Medical Devices Act 2021 to give effect to the policy outlined in this consultation document would be to safeguard public health.

In considering this policy and the regulations which may be needed to give effect to it, the Secretary of State has had regard to:

The safety of medical devices within the scope of this policy

The safety of the testing kits themselves is unlikely to be effective as they do not represent a health risk in and of themselves to an individual if misused. They do however present a risk to the general public health as poor information can lead to the virus spreading.

Any impact of this proposal on the safety of the COVID-19 tests will be positive, since it will ensure that only tests meeting a minimum standard of accuracy are available on the UK market. It is therefore considered that this proposal does not create any risks for the safety of medical devices. The rigorous validation process set out above ensure test of are of sufficient quality to protect the public health.

The availability of medical devices within the scope of this policy

Creating a new regulatory standard will limit those tests that would not meet this standard from entering the market. This in theory will reduce the number of tests available to the UK market. However, in reality we are removing tests from circulation that could be a threat to public health due to their higher than tolerable propensity to give false results. Given the impact false negatives can have on the public health as users can unwittingly infect others having been given the confidence not to self-isolate by a poorly performing test justifies removing them as they can in reality be worse than useless and present a harm to the public health.

I do not believe the type of validation we are proposing nor the fees or time the process will require, will act as a deterrent to manufacturers of quality tests, given both the size of the businesses involved and their experience with dealing with such processes.

The creation of a highly respected validation process could create a market efficiency with high quality tests seeking the UK market and poor quality tests self-allocating themselves out, or striving to raise their standards to a sufficient level. In either scenario we the supply of high quality tests is unlikely to be impacted.

Whether the United Kingdom is likely to be seen as a favourable place in which to: research the medical devices within the scope of this policy, develop medical devices within the scope of this policy or manufacture or supply medical devices that come within the scope of this policy

As set out in the qualitative analysis in the private market section, I do not believe a validation regulatory regime of this kind will deter any business from researching or manufacturing COVID-19 tests in the UK.

It may dissuade suppliers of low quality tests from bringing stock to the UK, however I do not consider this to be a negative impact but a positive as we wish to focus our market solely on high quality tests.

Good regulation will give business clear and consist rules. This is something all businesses rely on. I fully intend for the resulting SI to be just such an example of good regulation.

The Secretary of State, having assessed the above criteria and his overarching objective to safeguard the public health, notes the minor risk to the supply of COVID-19 tests but believes this is negligible in regard to tests of sufficient quality to be an effective tool in identifying infections early. The removal of poor quality tests is a more substantial benefit to the protecting public health.

The Secretary of State will continue to assess the matters set out in section 15(2) to (4) before making any regulations under section 15 to give effect to the policy proposed in this consultation.”

1. Centre for Disease Control and Prevention, Candida auris, Fungal Diseases, CDC. ↩