   
  
G/TBT/N/GBR/39/Add.1  
 
3 June 2021  
(21-4568) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  28 May 2021 , is being circulated at the request of the delegation 
of the United Kingdom . 
 
_______________  
 
 
Title: Covid -19 Detection Test Regulation [proposed title] (09/04/21 is the original distribution date)  
 
Reason for Addendum:  
[X] Comment period changed - date:  11 June 2021; Originally notified under Article 2.10 as 
an urgent measure.  
[  ] Notified measure adopted - date:  
[X] Notified measure published - date: 14 June 2021  
[X] Notified measure enters into force - date: 30 July 2021; Originally notified under Article 
2.10 as an urgent measure.  
[  ] Text of final measure available from1:  
[  ] Notified measure withdrawn or revoked - date:  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://members.wto.org/crnattachments/2021/TBT/GBR/modification/21_3747_00_e.
pdf 
This measure was originally notified under 2.10 on 9/4/2021 as G/TBT/N/GBR/3 9. The 
draft text of the regulation is now available, attached as an addendum.  
New deadline for comments (if applicable):  11/06/2021  
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  Following consultation, the United Kingdom Government  has now developed a draft of 
the regulation for Mandatory Validation of Covid 19 In vitro  Diagnostic antigen and Molecular tests. 
This text will amend the Medical Device Regulations 2002, using powers provided in the Medicines 
and medical Devices Act 2021. The legal text is available on request.   
__________  
 
 
 
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.  