I've had a quick read of some info on a couple of the UK sites. The MHRA approves exceptional use for self-tests so we won't appear on that list you linked. But I agree, I think we need to be on the general list that you linked first. (Happy to be corrected if I'm wrong) So, if we're not on that MHRA list, what was the whispering about testing with NHS last year? Hyped up rumour? I guess Anteo tech aren't selling into the UK, just "Europe"?
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market (extract below)All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).
In Great Britain devices must conform to the Medical Devices Regulations 2002](http://www.legislation.gov.uk/uksi/2002/618/contents/made) (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be placed on the market and registered with the MHRA.
Registration requirements differ for .
https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-patients-the-public-and-professional-users-a-guide-to-covid-19-tests-and-testing-kits(Extract below, apologies for the wall of text)
Lateral flow antigen test or rapid antigen test
Lateral flow antigen tests are rapid turnaround virus tests that can process COVID-19 samples on site without the need for laboratory equipment, with most generating easy-to-understand results in under half an hour. Because of this, they can be performed in a laboratory or a point of care setting.
Public Health England (PHE) and the University of Oxford have recently carried out extensive clinical evaluation studies on lateral flow tests.
In the UK, the MHRA has granted NHS Test & Trace an exceptional use authorisation to use certain lateral flow devices as self-tests to detect infection in asymptomatic individuals who otherwise would not be tested. For more information, please see the section on self-testing.
Sample collection kits
A sample collection ‘kit’ is the name given to the different parts of a COVID-19 test that help obtain a ‘sample’. This kit must have a valid CE, CE UKNI or UKCA mark to show that the manufacturer has met the minimum safety and performance requirements for the product.
The sample you have to provide, and whether or not you can collect that sample yourself, will depend on what type of test you are having.
Please note that not all sample types have been proven to be effective in COVID-19 testing.
How COVID-19 testing is regulated
Sample collection kits and the COVID-19 tests are medical devices. For a medical device to be safe to use, it must have a valid CE, CE UKNI or UKCA mark. These marks are a declaration by the manufacturer that the test meets the required standards of safety and performance.
These regulatory requirements aim to ensure that the products do not compromise the safety of patients and users and are designed and manufactured to achieve the performance specified by the manufacturer for the stated purpose.
CE, CE UKNI and UKCA marks are not issued by the MHRA. They are placed on the product by the manufacturer. Before the product can sold in the UK the manufacturer or their UK Responsible Person (UKRP) must register it with the MHRA.
Tests specifically used for self-testing will need to have been deemed acceptable for CE/CE UKNI/UKCA marking by an Approved or Notified Body or have been granted an Exceptional Use Authorisation by the MHRA. This is indicated by a CE, CE UKNI or UKCA mark and a 4-digit identifier number next to the CE mark symbol on the packaging. Tests which have been granted an Exceptional Use Authorisation.
There are a number of lateral flow antigen self-tests which have now received CE certification from an EU notified body.
The MHRA administers and enforces the law on medical devices in the UK and has a range of investigatory and enforcement powers to ensure the safety and performance of medical devices in the UK.
For more information, please read our guidance on how In Vitro medical devices such as these are regulated.
(20min delay)