ABHI statement on the Coronavirus Test Device Approvals (CTDA) process
The Association of British HealthTech Industries (ABHI) has called for the UK Health Security Agency (UK HSA) to remove the confusion and uncertainty surrounding the implementation of the Coronavirus Test Device Approvals process (CTDA). Specifically, ABHI has asked UK HSA to make all decisions transparent, extend the transition period for all products, adopt a more flexible approach to ensure supply security and resilience, and allow sufficient time to properly and fairly implement this legislation in line with the needs of the NHS.
Implementation of this legislation has already led to the needless withdrawal of COVID-19 tests with no identified deficiency, which, as we face a critical time in the evolution of the pandemic, has weakened supply resilience in our country and threatens to disrupt testing capacity and capability.
ABHI has consistently and repeatedly pointed out that these additional regulatory hurdles will not serve the purpose for which they are intended.
Notes to Editors
ABHI supports the HealthTech community to provide products and services that help people live healthier lives. As the voice of the industry, we show the value of health technology and overcome barriers to people benefitting from it now and in the future. Members include leading multinationals through to small and medium sized enterprises. We represent the HealthTech industry to key stakeholders, such as governments, healthcare systems and regulators.
From 28th July 2021, it is law that manufacturers or distributors supplying COVID-19 tests must apply to the Department of Health and Social Care (DHSC) for approval through a desktop review process. Products must meet the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021. Further information is available here.
Previous ABHI statements on the proposed legislation are published here:
- ABHI Postition on DHSC Open Consultation on Private COVID Testing Validation. 26th April 2021.
- ABHI & BIVDA Joint Position on DHSC Consultation on COVID Test Laboratory Validation. 28th September 2021.
Findings of an industry survey on the impact of CTDA
ABHI acknowledges concerns over the existing validation process for, and the quality of, some COVID-19 tests that are currently being supplied, and support action to remove poor quality tests from the market.
However, implementation of CTDA has disproportionately and unfairly damaged the UK diagnostics industry.
An industry survey of products that were approved, or temporarily listed as exempt from the requirements of the process, showed that three quarters of large companies appear on one or both lists (approved or exempt), but fewer than half of smaller companies appear on either. Only one in ten large companies have no products listed, compared with two thirds of smaller ones.
The confused and confusing implementation of the legislation has restricted the UK supply of COVID-19 tests to a few larger companies at the expense of smaller ones. Smaller companies now feel restricted in their ability to quickly bring new products and ideas to the market. By disproportionately affecting smaller businesses, this legislation has undermined confidence in the aim of the Life Science Vision to build a robust UK diagnostics industry.
Nishan Sunthares, ABHI’s Managing Director, Diagnostics said “We have called on UK HSA to act quickly to bring clarity to the market and to allow sufficient time to properly and fairly implement this legislation in line with the needs of the NHS. Without a full and open rationale as to why their products have not been listed, manufacturers have been left confused and unsure about what they are able do with their tests. This has been compounded by delays in communications to applicants detailing precisely what is required for approval.
The supply chain has almost immediately become more fragile and less resilient. Furthermore, NHS and private laboratories must now spend time and effort transitioning to new tests in an attempt not to disrupt the NHS Winter Plan.”
8th November 2021