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Coronavirus Test Device Approval Update
24 February 2022
Type
Written Ministerial Statement
Department
Department of Health and Social Care
At a Glance
Issue Summary
The statement addresses the approval process for coronavirus test devices under the CTDA regulations, highlighting efforts to ensure high-quality tests are available while addressing public health risks.
Action Requested
From March 1, 2022, two new protocols will be implemented to permit certain devices with pending validation applications to remain on the market until May 31 and August 31, 2022, respectively. These protocols aim to mitigate supply chain disruptions and risks to vulnerable individuals.
Key Facts
- The CTDA regulations set high standards for specificity and sensitivity of tests.
- As of February 24, 2022, there were 212 applications across antigen and molecular test devices.
- 31 devices are currently approved on the products list.
- Regulation 39A of the Medical Devices Regulations 2002 is being exercised to permit tests with pending applications until February 28, 2022.
- Two new protocols will be created: one for three months (until May 31, 2022) and another for six months (until August 31, 2022).
- Tests permitted under the protocols have undergone similar validation previously by a public sector body.
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