Closed call for evidence

Coronavirus Test Device Approvals (CTDA): call for evidence

Published 6 September 2022

Executive summary

On 28 July 2021, legislation came into force which introduced validation for antigen and molecular coronavirus (COVID-19) detection tests. The statutory instrument made under the Medicines and Medical Devices Act 2021 requires antigen and molecular COVID-19 tests to undergo mandatory desktop review to assess their performance before being put into service, supplied, and permitted for sale on the UK market.

This call for evidence aims to support our understanding of the impact the Coronavirus Test Device Approval (CTDA) process has had on the wider internal market, individual business and trade flow of antigen and molecular COVID-19 detection tests.

This will support the wider statutory review of the policy that will be reported on by 31 December 2022.

The call for evidence aims to obtain specific evidence in relation to businesses operating in the COVID-19 diagnostics market.

We are seeking evidence and opinions on the following areas:

• costs for individual businesses involved in the domestic COVID-19 test kit sector
• scale and nature of domestic COVID-19 test kit activity, including manufacturing and trading
• scale and nature of activities abroad which are integral to our existing domestic COVID-19 test kit supply and market
• the direction of the COVID-19 test kit market
• how the CTDA objectives have been met and if they could be met more efficiently in future

Privacy notice

The questions forming part of this review include requests for information which may be commercially sensitive. Such information will be used by the Department of Health and Social Care (DHSC) for the purposes of this statutory review only. However, no commercially sensitive information will be published in the review itself. Any personal data (for example, names and email addresses) provided to DHSC as a result of responding to the questions below will be processed in accordance with DHSC’s privacy notice.

Introduction

We want to build our understanding of the economics of the COVID-19 testing market in the UK. To do this we need more information about both the broad strokes of supply and demand dynamics as well as the fine detail of business costs and individual behaviour around testing.

This call for evidence seeks substantive submissions from all interested stakeholders.

We would welcome submissions of both analysis and underlying calculations and evidence.

We welcome submissions on any or all the below broad areas:

• costs for individual businesses involved in the domestic COVID-19 test kit sector
• scale and nature of domestic COVID-19 test kit activity including manufacturing and trading
• scale and nature of activities abroad which are integral to our existing domestic COVID-19 test kit supply and market
• the direction of the COVID-19 test kit market
• how the CTDA objectives have been met

We have also set out some more specific questions to help guide respondents so that your submissions will be easy for you to structure and will add maximum value to our policy development and analysis. These are set out at high level here and in more detail in the call for evidence questions below.

Submissions may focus on any individual question or cover them all.

The costs to business incurred as a result of CTDA

Changes in cost to business (either negative or positive) caused by the implementation of CTDA and the ongoing development and compliance costs associated with this.

Future business planning

This includes:

• business’ planning assumptions within the private market for COVID-19 tests, considering the uncertain situation the virus has presented
• the impact of external variables, including new technologies, changing epidemiological patterns and government policy on free asymptomatic testing

Understanding the market

This includes:

• the life cycle of a COVID-19 detection test product
• views on the UK and global COVID-19 diagnostics market and economy
• views on the public perception of testing and expected uptake of testing services and devices
• potential impacts upon supply chains
• size and volume of COVID-19 tests on the market

Who can respond

We welcome all evidence and analysis any stakeholder can provide on these broad topics.

We are particularly interested in responses from:

• manufacturers of COVID-19 or other diagnostic tests
• distributors of COVID-19 or other diagnostic tests
• industry bodies
• academics and experts in the diagnostics industry
• think tanks and other research groups with relevant insight
• any others with evidence of potential impacts

We will not publish any identifiable or commercially sensitive data unless you indicate in your response that you are happy to be referred to. We invite you to submit a response to the questions outlined below. You do not have to answer all questions, but the more information provided supports our policymaking and evaluation.

The call for evidence will run for 6 weeks, ending on 18 October 2022.

How to respond

We invite you to submit written responses via email. Fill in your responses to the questions and email CTDA.policy@ukhsa.gov.uk

Read the background on the policy and legislation in this document and use the questions here only for reference. This is not an online form.

Background on the policy and legislation

Legislation

On 28 July 2021, it became a legal requirement to seek UK government validation for antigen and molecular COVID-19 detection tests intended for sale on the UK market.

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

Those tests that do not pass the validation assessment and meet a minimum performance threshold cannot be legally placed on the market and put into service or supply in the UK. The government publishes a register of tests that have passed validation to make it easy for consumers to make informed choices about the tests they purchase.

Desktop review

The desktop review is intended to prevent products that are below the minimum standards from progressing to the market as set out in the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021.

The desktop review is an assessment of the evidence a manufacturer or distributor submits to support the performance of their product.

Applicants are required to submit information related to the following areas for basic checks:

• manufacturer and product information
• regulatory status
• product performance
• biosafety
• supplementary documents (for example, current versions of the instructions for use, biosafety documents, evidence of performance characteristic)

The desktop review assessment is then completed in 3 steps:

1. A scientific adviser reviews evidence provided by the applicant.
2. The Desktop Review Assurance Group assesses this review and makes a recommendation.
3. The Regulatory Approvals Committee then considers it.

Read more detailed guidance on the process of applying for desktop review.

Demographic questions

Thank you for responding to this call for evidence.

We welcome all evidence and analysis any stakeholder can provide on these broad topics.

Please answer all questions as far as they are applicable to you. This will help us to understand the make-up of respondents and analyse your responses.

For example, if you’re responding on behalf of an individual, please answer questions addressed to organisations where you can (for example, on location and nature of work).

All information will be handled in line with the privacy notice, including commercially sensitive information.

Questions

1. Are you responding on behalf of an individual or an organisation?

2. What is the name of your organisation?

3. In which country is your headquarters based?

4. On what date was your organisation established?

5. If your organisation is part of a group of companies, what is the name and location of the parent organisation?

6. If UK-based, select the nation or region your organisation is based in:

• Scotland
• Wales
• Northern Ireland
• North East of England
• North West of England
• Yorkshire and the Humber
• East Midlands
• West Midlands
• East of England
• London
• South East of England
• South West of England
• other (please state)

7. What is the nature of your organisation?

• manufacturer
• retailer
• distributor
• trade association
• other (please state)

8. Does your organisation manufacture COVID-19 detection tests? (If yes, specify the type of tests.)

9. Does your organisation distribute or sell COVID-19 detection tests? (If yes, specify if your organisation sells directly to the patient – for example, high street retailer.)

10. Does your organisation currently sell COVID-19 detection tests on the UK market?

11. Have you applied, or are you currently applying to have a test approved?

12. Does your organisation manufacture or distribute other diagnostic tests (not COVID-19 detection tests)? (If yes, please specify.)

13. If yes to the above questions, in which country are your tests manufactured? Have you manufactured elsewhere in the past?

14. Is the production/sale/distribution of COVID-19 tests your main area of business? If not, what is?

15. How many employees are in your organisation?

• 0 to 4
• 5 to 9
• 10 to 19
• 20 to 49
• 50 to 99
• 100 to 249
• 250 or above

16. Can we contact you with follow-up questions?

17. If you’re happy to be contacted, what is your email address?

18. Can we cite you directly in publications such as the evaluation or statutory review?

Call for evidence questions

Below are several detailed questions to help guide your responses and highlight the evidence we are most interested in receiving.

The answers to these questions will more closely align with our analytical needs and the specific policy issues where we want to build our underlying understanding.

You do not need to answer all questions, but please answer questions which are relevant to you as fully as possible.

Any commercially sensitive data you use to support your responses will only be used for the purposes of understanding your experiences of CTDA and help us to effectively review this policy area.

1. Impacts on business of CTDA

We invite manufacturers, suppliers, and retailers of COVID-19 tests to respond to the questions within this section. If you are not directly involved and are instead providing an estimate from an expert or academic perspective, please indicate this in your answer.

It is important that we understand as much as possible about the impact the legislation introducing mandatory validation for COVID-19 detection tests has had on cost or benefit to business so we can build upon its benefits while addressing the challenges it has raised.

1 (A) Profits

We want to collect detailed evidence of the gross profit margins over time of those involved in the supply of COVID-19 tests.

1. Please outline supported by evidence any changes in gross profit margins per device since July 2021, or since your application(s) for your test device(s) was submitted. Please explain what elements you are including in the cost of sales (for example, fixed costs, research and development spending, branding).

2. Please explain what elements you are including in the cost of sales (for example, fixed costs, research and development spending, branding).

1 (B) Costs

We want to collect detailed evidence of the costs involved in complying with the CTDA process and in supplying COVID-19 tests.

1. Please outline, supported by evidence, the total costs of applying for the CTDA process. Please show both the itemised cost and staff hours spent. Please identify the number of applications you have made and the outcome of each. Please include in your answer what activities you are including in the costs.
2. What is the average per unit production cost for COVID-19 tests?
3. What is the investment that companies make in meeting new regulations on average?

1 (C) Investment

We are interested in finding out how much it costs manufacturers to make improvements to their products, how often they revise tests and the associated costs in doing so.

1. Can you estimate how much it would cost, on average, to modify a COVID-19 detection test? Please support your answer with evidence.
2. Who would typically bear the cost of a reinvestment (for example, manufacturers in reduced profits or through cost cutting, equity holders in reduced dividends or further investment, or customers in prices)?
3. How much would you estimate that it costs to bring a new product to market? Please outline:
   a. financial cost
   b. amount of time taken to bring a product to market
   
4. What are your investment plans for COVID-19 diagnostic devices?

1 (D) Future business planning

We invite manufacturers, suppliers, and retailers of COVID-19 tests to respond to the questions within this section.

Given the uncertain situation surrounding COVID-19, we are interested in understanding how businesses in the market for private COVID-19 testing devices and services are currently planning for the future.

1. Please set out your future business planning assumptions; what opportunities, dependencies or risks you may have identified and what horizon period you are planning.
2. How is the uncertainty of future pandemics impacting your business planning decisions?

For example, external variables such as the potential for the emergence of new variants (or, if you are not a business, how do you predict these will impact these decisions?)

1 (E) Product life cycle

We are interested in your assessment of your products’ life cycles to gauge how often businesses must redevelop or update products to meet changing requirements.

1. What is the average life cycle for your product or products or a COVID-19 diagnostic device?

1 (F) COVID-19 epidemiology

COVID-19 is still an active public health issue and, as a result, we are interested in your thoughts on COVID-19 epidemiology and how you expect this will affect your business and the wider COVID-19 diagnostics market.

1. How do you expect new variants to impact the UK COVID-19 diagnostic market over the next 12 months?
2. What planning to replace or alter existing diagnostics devices do you conduct or think is appropriate for a manufacturer to conduct to ensure diagnostics remain effective at detecting new variants?
3. Are you expecting to withdraw any tests from the market due to new variants?

2. Analysis of the wider market

In this section, we are seeking evidence regarding the wider market.

This will enable us to set the evidence of the experience of individual players in the broader context. It will also provide evidence of consumer experience. It will help us develop analysis of the likely shape of the market going forward and in turn analyse the best type of regulation to protect consumers going forward.

2 (A) Interaction with universal free testing

To meet the public health risk of the pandemic the UK provided free tests to all citizens on request.

We recognise that the universal testing offer (UTO) was a major intervention in the market and it distorted demand and supply of tests into the market. We are keen to understand the impact this had on consumers, retailers, suppliers, and manufacturers.

1. Please describe how the UTO affected your business. What changes did the ending of the UTO have on your business?

2 (B) Understanding the market

We invite stakeholders involved in the manufacture, distribution or retail of COVID-19 or other diagnostic tests, academics, and experts in the diagnostics industry to respond to the questions within this section.

We are interested in understanding more about the size, structure, and investment within the COVID-19 diagnostics market. Please support your answer with evidence.

1. The size, volume and value of the COVID-19 test market.
2. What the supply chains look like and consist of.

2 (C) Market predictions

To understand the mindset many companies operating in the UK diagnostic devices market will be acting under, we are interested in collecting economic predictions for the next 2 years. This will enable us to understand the thinking behind business decisions in this sector.

1. Please set out, with evidence, the levels of growth you expect to see in the diagnostic devices markets in the UK and internationally, particularly for COVID-19 devices.
2. Do you expect there to be similar levels of demand for testing in the private market if another pandemic (other than COVID-19) were to emerge?

Consumer behaviour

The key issue in the early COVID-19 diagnostic devices market was the information asymmetry between sellers and consumers. The information provided was often not reflective of actual performance, confusing and not comparable with other products. Policy objectives included addressing this issue, protecting test users from poor quality tests and improving consumer confidence.

We are interested in your experiences of changing consumer behaviour and how CTDA has informed and affected this. We would like to collect evidence regarding how consumers reacted to the pandemic in terms of purchasing COVID-19 diagnostic tests or testing services, and the extent to which the CTDA market intervention have impacted the consumer experience.

1. If you have procured or purchased tests for your organisation, did you use the CTDA register to inform your decision?
2. Are there any improvements to the register you can suggest?
3. What trends in consumer confidence in COVID-19 diagnostic devices have you observed?
4. To what extent do you believe consumer behaviour regarding illness and diagnostics has changed due to the pandemic?
5. Outside of medical diagnostics over the next 10 years, what activities, business areas or types of consumers will make regular use of COVID-19 testing?
6. Are you working with other businesses and, if so, do these businesses want to test staff or customers (or both) in the absence of government requirements to do so?

3. International regulation and trade flows

3 (A) International regulatory environment

We are interested in how the CTDA experience compared to other international jurisdictions. We are particularly interested in the impact of regulation and the application journey when compared to regulation in the US, Canada, Australia, and South Korea.[^{[footnote 1]}]

1. What comparisons can you make between CTDA and other regulatory regimes internationally? Please include views on levels of scientific rigour, fees and if they met in their countries the 5 objectives of CTDA. Please support your answer with evidence.

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 product and as such could act as an incentive to consumers particularly when coupled with the register information available online.

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

3 (B) Trade flows

Trade in diagnostic devices expanded massively over the pandemic.

The UK and other developed markets experienced large influxes of test devices particularly from manufacturers based in the far east. In addition, there were many new entrants to the market. Understanding these aspects and the impact that regulation had on these flows will be important to the evaluation.

We are interested in understanding more about the flow of COVID-19 test products in, out and around the UK.

1. Where in the UK do you import to, and where do you import from?
2. Where in the UK do you export from, and where do you export to?

4. CTDA application and administration

The CTDA was rapidly set up within DHSC as the body able to deliver a regulatory regime in the timings dictated by the pandemic. This required quickly standing up both an operational team and scientific advisors. In addition, a portal had to be designed and developed to receive applications.

It was important to ensure that the evidence received from companies was of a sufficiently high quality to make a decision.

Though we recognised the higher level of rigour CTDA required compared to the EU regulations, a large number of companies in a scientific focused sector were unable to provide evidence of the quality required.

To support industry and manufacturers, rather than reject these applications, scientific advisors have provided extensive support to help these applications meet the evidential standards required. This has impacted the speed of applications through the process.

4 (A) CTDA application process

CTDA was designed as a scientifically rigorous yet efficient process. However, we recognise some elements on evidence standards were novel and challenging to some in industry to adapt to. We would like to hear about your experiences when applying through CTDA. This includes the evidence you prepared for the application and your communication with officials.

1. We invite stakeholders involved in submitting an application for COVID-19 tests to provide their experiences of the CTDA application process. Please provide as much detail as you can, including when you made an application and when you received your decision.

4 (B) CTDA administration

The CTDA has been administered since inception by the UK Health Security Agency (UKHSA) (and its predecessor NHS Test and Trace). It has used an online portal to receive applications and fees payment. A team of operational staff manages the applications through the system and supports the scientific advisors in their work.

1. Please provide any other experience supported by evidence of the performance of the CTDA scheme not covered by the previous section. Please include experience of complaints or re-review process in this answer.

5. CTDA objectives

During the pandemic there was high demand for COVID-19 diagnostics and there was an influx of new entrants to the market with a broad range of tests they were placing on the market. Existing EU regulation, including third-party conformity assessment, had failed to prevent poor quality COVID-19 tests entering the market.

This created a confusing marketplace for consumers and risked undermining attempts to combat the pandemic. CTDA was established with 5 overarching objectives to address this market failure and associated public health risk.

These objectives are set out below:

• reduce false negative and false positive test rates to help manage the spread of the disease, reduce incidences of unnecessary self-isolation and contact tracing
• correct the market failure, particularly the information asymmetry that prevented consumers from understanding or being able to compare test devices
• ensure all tests on the UK market were of the same standards as those used in the NHS, so that they can contribute to empowering people to manage their own health and combat the pandemic
• increased reliability of test products and easier comparability of their performance should drive increased take-up of testing by employers and institutions
• increased consumer confidence in test and subsequently, increased volumes of private tests being reported

1. Do you consider that these objectives remain the appropriate ones for validation of COVID-19 test devices?

2. For each of the above we would welcome your thoughts on whether you think these objectives have been met, how they have been met and whether you can propose any better or less onerous ways of achieving them. Please support your answers with evidence.

Closing questions

1. Are you aware of any research that would be useful to this evaluation? Please provide as much detail as you can and any links, journal numbers and so on.
2. Please provide any evidence you think would be useful to this analysis not covered in the preceding questions.

Next steps

We will collate and analyse the responses we receive to this call for evidence, and we will use this to develop our analysis of the CTDA policy. When we are satisfied that we have collected the best evidence possible, we will submit our findings to the Regulatory Policy Committee for their review.

This analysis will feed into the wider policy review of the CTDA process which will be published by 31 December 2022.

Thank you for responding to this call for evidence.

Annexe A: Guidance document

CTDA call for evidence - guidance

This document will accompany the main call for evidence questions and provide additional guidance on how to answer each question and what you may wish to consider in your answers.

Considering the following points and questions in your responses will ensure we can collect comprehensive views to allow us to fully evaluate the policy based on your perspective.

You do not need to answer those questions which are not applicable to you, but please provide detailed responses and supporting evidence for the questions you do respond to.

Please see below further guidance on the key questions we would like you to answer.

Profit and costs

In addition to the main questions on profit and costs, please also consider the following questions regarding profit, loss, and costs:

• losses incurred because a product failed to meet CTDA standards
  • total cost
  • hours lost
• losses incurred because a product was not put forward for CTDA validation
  • total cost
  • hours lost
• costs incurred due to reinvestment in a product to achieve successful validation
  • total loss
  • hours lost
• total increase in profits since the implementation of CTDA in July 2021
• gains in profit after successful CTDA applications
  • total gain
• gains in profits as a result of reinvestment in a product
  • total gain
• total increase or decrease in costs directly related to compliance with CTDA regulations since July 2021
• estimated compliance costs
  • cost per hour
• How were any losses incurred to the business absorbed (for example, higher costs passed onto consumers, cuts in dividends and so on)?
• What are your import costs?
• Have you incurred any additional costs because of data collection related to the CTDA application? What are these?

Are there any other areas not covered above where you have experienced direct or indirect losses or gains to profits as a result of the CTDA process?

Estimate your profit margins from the choices below:

• negative gross profit margin
• 0% to 10%
• 11% to 20%
• 21% to 30%
• 31% to 40%
• 41% to 50%
• 51% to 60%
• 61% to 70%
• 71% to 80%
• 81% to 90%
• 91% to 100%

Polymerase chain reaction (PCR)

• current gross profit margin
• target gross profit margin

Lateral flow devices

• current gross profit margin
• target gross profit margin

Other (please specify):

• current gross profit margin
• target gross profit margin
• In calculating the gross profit margin above, what elements have you included in the cost of sales (for example, fixed costs, research and development spending, branding)?
• What proportion of devices currently available on the market would you anticipate presenting to the scheme for validation, rather than being excluded from the market?
• How this would vary by:
  • technology type
  • country of origin
  • size of revenue

Investment

In addition to the main questions on investments, please also consider:

1. What would be the most likely scenario if a COVID-19 test product failed validation?
   • product is discontinued; exit the market
   • redesign and resubmit for validation
   • seek alternative international markets
   • other (please specify)
2. How this would vary by:
   • technology type
   • country of origin
   • size of revenue

Future business planning

We are interested in any future business planning you have undertaken to gauge the trajectory of the COVID-19 diagnostics market. In addition to the main questions on future business planning, please also consider:

• What horizon period are you currently planning for within your business planning?
  • 0 to 6 months
  • 7 months to 1 year
  • 1 to 2 years
  • 2 to 3 years
  • 3 to 5 years
  • 5 to 10 years
  • more than 10 years
• What opportunities have you identified over the next year within the COVID-19 private testing market?
  • Do you expect the market for COVID-19 private testing to grow or shrink? By how much (%)?
  • Are there any dependencies or risks attached to this? Where possible, please break this down by technology type (for example, PCR demand vs lateral flow device demand)
  • Do you plan to increase investment into COVID-19 test products over the next few years?
  • If you currently only produce COVID-19 tests, will you continue to exclusively sell into the COVID-19 testing market, or do you have plans to expand into the wider diagnostics market?
  • Do you expect pandemics, such as COVID-19, to become more common occurrences? If yes, has this increased or decreased your desire to retain resources in the diagnostics market?
  • Before bringing a COVID-19 testing device or service to market in the UK, for how long in years and months have you been involved in the diagnostic testing sector?
    • years
    • months

Interaction with universal free testing

In addition to the main questions on interactions with the universal testing offer, please also consider:

• How has the end of the UTO (free tests offered to the public by the government) impacted your businesses profitability and business planning decisions?
• How is the uncertainty of future pandemics impacting your business planning decisions? For example, external variables such as the potential for the emergence of new variants (or, if you are not a business, how do you predict these will impact these decisions?). Do you expect there to be similar levels of demand for testing in the private market if another pandemic (other than COVID-19) were to emerge?

Research in the market

We would welcome any research you may be aware of that would be useful in our analysis of the UK private market for tests:

• Are you aware of any research which you believe accurately represents the volume of tests available on the private market in the UK? Please provide the title and source, and a brief summary.
• Are you aware of any research which highlights good management of supply chains to deliver COVID-19 test products to the UK market? Please provide the title, a source, and a brief summary.
• Are you aware of any research that best represents the size of the UK’s diagnostics market, or market for COVID-19 tests?
• Are you aware of any research that estimates the value of the UK diagnostics market, or market for COVID-19 tests?

International regulation and trade flows 

In addition to the main questions on international regulation and trade flows, please also consider:

• How effective at addressing information asymmetry in the market is CTDA compared to other regulatory regimes internationally?
• How effective at addressing the public health risk of inaccurate results is CTDA compared to other regulatory regimes internationally?
• How do CTDA application fees compare to other regulatory regimes internationally?
• Are you aware of any other regulatory regimes internationally offering a small and medium enterprise (SME) discount? If so, how is an SME defined? And what are the discounts rates?
• How quick is it to get a CTDA decision compared to other regulatory regimes internationally?
• Which countries do you import or export COVID-19 products from or to?
• What affects your decision to import COVID-19 products from a particular country?
• What affects your decision to export COVID-19 products to a particular country?
• If you are manufacturing in the UK, where are your manufacturing centres?
• Have you considered shifting your business out of the UK? If so, why?

Consumer behaviour

In addition to the main questions on consumer behaviour, please also consider:

• Was the information on the CTDA register useful?
• Did you find it easy to compare the information between different tests on the register?
• Is there any information absent from the register you would have found useful in informing purchasing decisions?

Product life cycle

We are interested in your assessment of your products’ life cycles to gauge how often businesses must redevelop or update products to meet changing requirements:

• What is the average life cycle for your product or products or a COVID-19 diagnostic device?
• How would this vary by technology type? For instance, how long would a device last for before manufacturers decide to update or make substantive changes to their product (for example due to innovation, market competition or new variants)?

COVID-19 epidemiology

COVID-19 is still an active public health issue and, as a result, we are interested in your thoughts on COVID-19 epidemiology and how you expect this will affect your business and the wider COVID-19 diagnostics market:

• How do you expect new variants to impact the UK COVID-19 diagnostic market over the next 12 months?
• What planning to replace or alter existing diagnostics devices do you conduct or think is appropriate for a manufacturer to conduct to ensure diagnostics remain effective at detecting new variants?
• Are you expecting to withdraw any tests from the market due to new variants?

CTDA application process

We are aware that changes to regulatory processes can be challenging for businesses to navigate. We are therefore interested in your experiences of the CTDA application process.

Please consider the following in your responses:

• Have you been involved in applying for validation for a coronavirus test device?
  • yes
  • no
• When did you submit your application?
• When did you receive a decision on your application?
• Did you supply all evidence required with your initial application, or did you need to submit additional evidence?
  • all required evidence was submitted initially
  • additional evidence had to be submitted
  • application is still live, and I have had no requests for additional evidence
  • application is still live and additional evidence has been requested
• What, if any, challenges did you face when first making the application and during the validation process?
• If you sought a re-review what were your grounds for doing so?
• If you sought a re-review what was the outcome of the process?
• If you sought a re-review how was the process handled?
• Did you face any challenges after successfully passing validation?
• How were you supported through the process by UKHSA?
• How would you rate your experience of applying for validation? (This question is on a scale of one 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?
  • yes
  • no
  • I don’t know

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

1. We are asking about these particular countries as research conducted by the University of Cambridge and Sussex for UKHSA used these as comparators. ↩