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: submitSubmit 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: desktopDesktop review

The desktop review will assess each CTDA application against all criteria set out in the CTDA guidance below:

• For the standard CTDA pathway, see Standard CTDA destoppathway: reviewprocess guidancefor V4desktop review (PDF, 303 KB, 12 pages) guidance.
• For the accelerated CTDA pathway, see Accelerated CTDA acceleratedpathway: pathwayprocess for desktop review guidance V3 (PDF, 281 KB, 12 pages).
• AView the list of recommended acceptable comparator assays is available here: MHRA CTDA suitable comparators (ODS, (ODS, 16.3 KB).KB).

The assessment is done in 3 stages:

1. A scientific adviser reviews it.
2. The desktop review assurance group reviews the initial assessment.
3. The regulatory approvals committee reviews the assessment and issues the final recommendation.

If we need more information from you during the desktop review, the MHRA will reach out to the named person on the application and you must respond within 20 working days. If you do not respond within 20 days, your application may be rejected.

Application for Renewal of Expiring CTDA Certificates

This CTDA renewal process will extend CTDA certificates for a further five-year period, subject to the permitted changes described below. At the end of this extension period, devices will be expected to comply with the new requirements introduced under the draft Medical Devices (Amendment) Regulations 2026 SI.

Manufacturers remain responsible for ensuring that any changes made to their device continue to meet the applicable requirements set out in CTDA regulations and guidance. Where supporting evidence is required as part of the renewal process, this should be provided in accordance with relevant guidance and submission requirements.

The following sections describe the types of changes that are considered eligible as part of this renewal process.

Changes eligible for renewal process:

• Manufacturer address change
• UK Responsible Person (UKRP) change
• Additional swab provider
• Editorial or design-only updates that do not affect the content, such as branding changes, manufacturer logo updates, formatting, layout or visual presentation

Changes eligible for renewal process with supporting evidence for review (with the evidence requirements for each change):

• Device shelf-life extension or changes to sample storage conditions (Required evidence: stability study report).
• Addition of new sample collection media (Required evidence: matrix equivalency report).
• Improved clinical performance claims (Required evidence: completed Clinical Performance template with raw clinical performance data and send to CTDA@mhra.gov.uk
• Software updates (Required evidence: software validation report).

Changes NOT within the scope of the renewal process:

• Intended use changes
• Additional specimen types (e.g. nasal to nasopharyngeal)
• Additional gene targets
• Changes to RT-PCR protocol
• Changes to extraction and amplification platform

Step 1: Submit your Application

An applicant can submit a CTDA renewal application and the following supporting documents through the CTDA Renewal Portal: 

• CTDA-approved version of the IFU
• Current version of the IFU (if different to CTDA-approved version)
• Required evidence as per guidance

The fee will depend on the size of the organisation applying for renewal. You can apply for the discounted price if your organisation has no more than 250 individuals in total.

• Full price: £420
• Discounted price: £168

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.

Step 2: Update DORS Registration

After receiving a CTDA Renewal Certificate, applicants must upload this certificate to their device registration in the Device Online Registration System (DORS).

You can upload the MHRA CTDA Renewal Letter in DORS either at the point of registration or after registration:

• At the point of registration: follow the Add devices instructions in the Device Registration Reference Guide
• After registration: follow the Manage Registered Devices instructions in the Device Registration Reference Guide

Devices without UK Approved Body or EU Notified Body Involvement

On the Self-certification conformity declaration screen:

1. Upload and link your Declaration of Conformity
2. Upload the MHRA CTDA Confirmation letter using the Upload a new self-certification conformity declaration field
3. Enter “MHRA CTDA Confirmation letter” as the document reference name

Devices with UK Approved Body or EU Notified Body involvement

On the Conformity Assessment Certificate screen:

1. Ensure a valid Conformity Assessment Certificate is already linked (check that the Approved/Notified Body details and expiry date are correct)
2. Upload the MHRA CTDA Renewal Letter using the Upload a new certificate field
3. Select the same certificate type as the certificate issued by the Approved or Notified Body
4. Enter the expiry date of the MHRA CTDA Confirmation or Extension letter
5. Enter the certificate reference number as “MHRA CTDA Renewal Letter”
6. Select the same UK Approved Body or EU Notified Body designation as the certificate issued by the Approved or Notified Body

Outcome reporting

We only publish details of tests that have passed the CTDA process, showing:

• name of test

• name of manufacturer and business address
• name and business address of person who made application (if different to the manufacturer)
• date and version of the approved instructions of use
• type of test
• date of approval
• date the approval will cease
• other regulatory status and certification number
• country of manufacture
• approved sample type

Applicants appearing on the list must not use the name of the MHRA, or any Crown Body, to show preference to their products, services, or research.

Complaints

Applicants who want to complain about the process should email ctda@mhra.gov.uk.

You must include a full summary of the complaint and any supporting information you consider relevant.