   
  
G/TBT/N/GBR/39/Add.3  
 
20 October 2021  
(21-7936) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  20 October 2021 , is being circulated at the request of the 
delegation of the United Kingdom . 
 
_______________  
 
 
Title: Medical Devices Regulations 2002  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[  ] Notified measure published - date:  
[X] Notified measure enters into force - date: 1 November 2021  
[X] Text of final measure available from1:  
https://www.gov.uk/government/publications/covid -19-test-validation -approved -
products  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[X] Content or scope of notified measure changed  and text available from1: 
https://www.gov.uk/government/publications/covid -19-test-validation -approved -
products  
A protocol has been published to allow some Coronavirus In vitro diagnostic devices to 
stay on the market after 31 October without approval under regulation 34A of the Medical 
Devices Regulations 2002. The protocol will expire on 28 February 2022 and is published 
here: https://www.gov.uk/government/publications/co vid-19-test-validation -approved -
products  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  We are publishing a protocol under regulation 39A of the Medical Devices Regulations 
2002 which will allow certain Coronavirus test devices to remain on the market after 31 October 
without approval under regulation 38A(5).   These tests are the subject of a pending application for 
validation approval and will have to be removed from the market within 10 working days if their 
application is refused.   Permitting the tests listed in the protocol to remain on the market without 
approval is considered a necessar y and proportionate measure to address the serious public health 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/GBR/39/Add.3  
 
- 2 - 
 
  risk that a shortage of tests could create over the winter.   The protocol will expire on 28 February 
2022.  
__________  
 
 