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Guidance: COVID-19 test validation approved products

Department Of Health

November 25
15:18 2021

COVID-19 test validation approved products

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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 25 November 2021 +show all updates
  1. Updated spreadsheet with approved products added to the register.

  2. Removed 2 products from Protocol annexe (Roche and Life Technologies Corporation) as they have now passed CTDA validation.

  3. Removed Indicative performance category from spreadsheet.

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

  5. Updated COVID-19 test validation approved products.

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

  7. First published.

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