G/TBT/N/GBR/39  
9 April 2021  
(21-2984) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED KINGDOM   
If applicable, name of local government involved (Article 3.2 and 7.2):  N/A 
2. Agency responsible:   
Department of Health and Social Care  
39 Victoria Street  
Westminster  
London  
England  
SW1H 0EU  
UK 
Tel: 0207 210 4850  
Contact: https://contactus.dhsc.gov.uk/  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
UK TBT Enquiry Point  
Trade Policy Group  
Department for International Trade  
3 Whitehal l Place  
London  
SW1A 2AW  
TBTEnquiriesUK@trade.gov.uk   
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  HS3822  
5. Title, number of pages and language(s) of the notified document:  Covid -19 
Detection Test Regulation [proposed title]  
6. Description of content:  We ar e considering regulation to require the validation of all 
Covid -19 detection tests for human use made available for private sale. This would set 
minimum quality standards for specificity and sensitivity against which Covid -19 tests 
would be assessed. This would prevent retailers from selling tests that haven't been 
validated to meet this standard and place a requirement on manufacturers to seek 
validation for their tests. There would potentially be a broad suite of enforcement powers 
up to and including cri minal sanction. The intention would be to place the results of each 
test's validation in the public domain to inform consumer choice. In scope will be mature 
antigen detection and molecular detection technologies, as such the   main tests we expect 
to be as sessed are Lateral Flow Tests, and Polymerase chain reaction (PCR) tests. Given 
the urgency and the set up times we envisage doing this via a single government run 
process.  G/TBT/N/GBR/39  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicab le: We are considering regulation to require the validation of all Covid -19 
detection tests for human use made available for private sale. This would set minimum 
quality standards for specificity and sensitivity against which Covid -19 tests would be 
assess ed. This would prevent retailers from selling tests that haven't been validated to 
meet this standard and place a requirement on manufacturers to seek validation for their 
tests. There would potentially be a broad suite of enforcement powers up to and incl uding 
criminal sanction. The intention would be to place the results of each test's validation in 
the public domain to inform consumer choice. In scope will be mature antigen detection 
and molecular detection technologies, as such the main tests we expect to be assessed 
are Lateral Flow Tests, and Polymerase chain reaction (PCR) tests. Given the urgency and 
the set up times we envisage doing this via a single government run process; 
Protection  of human health or safety  
8. Relevant documents:   
a) Consultation on mandatory validation of Covid -19 Detection tests  
https://www.gov.uk/government/consultations/private -coronavirus -covid-19-testing -
validation  
Other documents : 
b) Medicines and Medical Devices Act 2021   
Medicines and Medical Devices Act 2021 (legislation.gov.uk)  
c) The Medical Devices Regulations 2002 (SI 2002 No 618, as amended)  
The Medical Devices Regulations 2002 (legislation.g ov.uk)  
d) General Product Safety Regulations 2005 (SI 2005 No 1803)  
The General Product Safety Regulations 2005 (legislation.gov.uk)  
e) Consumer Protection Act 1987  
Consumer Protection Act 1987 (legislation.gov.uk)  
f) Consumer Rights Act 2015  
Consumer Rights Act 2015 (legisl ation.gov.uk)  
9. Proposed date of adoption:  30 June 2021  
Proposed date of entry into force:  30 June 2021  
10. Final date for comments:  5 May 2021  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Department of Health and Social Care  
39 Victoria Street  
Westminster  
London  
England  
SW1H 0EU  
UK 
Tel: 0207 210 4850  
Contact: https://contactus.dhsc.gov.uk/