Coronavirus (COVID-19) test devices in the UK must apply for approval and meet the requirements set out in the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021.
From 24 May 2023, the management of the Coronavirus (COVID-19) test device approval (CTDA) process moved from the UK Health Security Agency (UKHSA) to the Medicines and Healthcare products Regulatory Agency (MHRA).
On 10 July 2025, the Government announced plans to remove the CTDA process, replacing it with Common Specification requirements for COVID-19 test devices. In the interim, the Government has introduced an Accelerated CTDA pathway for COVID-19 test devices that:
- Are CE-marked under EU IVDR, and
- Meet the Common Specifications requirements.
This pathway allows qualifying tests to undergo a more streamlined desktop review to confirm compliance with regulatory, performance, and safety requirements.
Under the draft Medical Devices (Amendment) Regulations 2026 Statutory Instrument (SI), coronavirus test devices with a valid CTDA certificate will have until the earlier of either five years from the date the SI comes into force, or the expiry date of their CTDA certificate, to comply with the new Common Specification requirements. The SI is expected to come into force in mid-2027. Manufacturers whose CTDA certificates are due to expire soon may apply for the CTDA Renewal Process to maintain compliance and continued market access during the transition period introduced by the SI.
Application for New CTDA Certificate
Step 1: Submit your Application
Manufacturers or distributors can submit a CTDA application to the MHRA for a new CTDA certificate via the Coronavirus (COVID-19) test device approvals service portal and pay the application fee.
The cost depends on the size of the company applying for validation. You can apply for the discounted price if your company has no more than 250 individuals in total.
- Full price: £14,000
- Discounted price: £6,200
You can use the following types of payment:
- credit or debit card
- wallet payment
No alternative payment method is accepted.
If you are having difficulty with the payment methods, email ctda@mhra.gov.uk.
If you withdraw from the process after you have made the payment, it will not be refunded.
Fees are the same worldwide and are taken in GBP.
The application will require information on:
- the manufacturer and COVID-19 test product
- regulatory status
- product performance
- biosafety
- supplementary documents (for example, current version of the instructions for use, biosafety documents, evidence of performance characteristic)
Step 2: Desktop Review
The desktop review will assess each CTDA application against all criteria set out in the CTDA guidance below:
The assessment is done in 3 stages:
- A scientific adviser reviews it.
- The desktop review assurance group reviews the initial assessment.
- The regulatory approvals committee reviews the assessment and issues the final recommendation.
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗