Guidance: COVID-19 test validation approved products

Department Of Health

November 15
10:54 2021

COVID-19 test validation approved products

This file is in an OpenDocument format

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email tell us what format you need. It will help us if you say what assistive technology you use.


Use the COVID-19 test validation approved products document to find out which products have been approved under Regulation 38A(5) of the Medical Devices Regulations 2002.

The Medical Devices Regulations 2002 Protocol, published under regulation 39A(2), permits certain coronavirus test devices to remain on the market without approval. The protocol sets out the conditions of this permission and the annex lists the coronavirus test devices that it applies to.

The protocol has been issued to address the serious public health risk any potential shortage of supply may cause. Supply of tests listed in the protocol annex must cease within 10 working days if the test fails validation. The protocol will expire on 28 February 2022.

Read the COVID-19 test approval: how to apply guidance to find out more about the validation methodology and application process.

Published 18 October 2021
Last updated 15 November 2021 +show all updates
  1. Removed Indicative performance category from spreadsheet.

  2. Updated 'Medical Devices Regulations 2002: protocol'.

  3. Updated COVID-19 test validation approved products.

  4. Updated 'COVID-19 test validation approved products'.

  5. First published.

Related Articles


  1. We don't have any comments for this article yet. Why not join in and start a discussion.

Write a Comment

Your name:
Your email:

Post my comment

Recent Comments

Follow Us on Twitter

Share This

Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: