MHRA Takes Over COVID-19 Test Device Approvals UK Process

• The UK's Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 require manufacturers to apply for approval.
• The MHRA took over management of the CTDA process from the UK Health Security Agency on May 24, 2023.
• Manufacturers must adapt to new requirements and comply with Common Specification standards by mid-2027 or face market access issues.

Manufacturers whose CTDA certificates are set to expire soon may apply for a CTDA Renewal Process to maintain compliance and continued market access during the transition period.

The UK's Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 require manufacturers and distributors of Coronavirus (COVID-19) test devices to apply for approval. However, a significant shift is underway. As of May 24, 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) took over management of the CTDA process from the UK Health Security Agency (UKHSA). This change has implications for manufacturers who must adapt to new requirements. The MHRA's role in overseeing COVID-19 test device approvals is a critical step towards ensuring public health and safety.

To facilitate the transition, an Accelerated CTDA pathway was introduced for qualifying tests to undergo a streamlined desktop review. This process confirms compliance with regulatory, performance, and safety requirements. The draft Medical Devices (Amendment) Regulations 2026 Statutory Instrument (SI) proposes replacing the CTDA process with Common Specification requirements for COVID-19 test devices. Manufacturers will have until the earlier of five years from the SI's effective date or their current CTDA certificate's expiry date to comply with these new standards.

Manufacturers whose CTDA certificates are set to expire soon may apply for a CTDA Renewal Process. This process extends the validity of their certificates for an additional five years, subject to permitted changes. During this transition period, manufacturers must ensure continued compliance with applicable requirements. The MHRA will assess each application against criteria set out in the CTDA guidance, which includes three stages: desktop review, assessment, and validation.

Manufacturers of COVID-19 tests must ensure compliance with the new Common Specification requirements by mid-2027, and may need to apply for a CTDA Renewal Process to maintain market access during the transition period.

Source: Original reporting via GOV.UK