The ICO agreed with me and forced the MHRA to release a document about the approval to repurpose the Innova LFTs

It was as I surmised, no regulatory oversight by the MHRA

Following on from these posts:

Let me tell you a story about LFTs

The LFT saga continues

I will read it in full later so I can understand it properly but I've received the document from the MHRA that the ICO forced them to supply about the repurposed Innova/DHSC LFTs.

The original Innova tests were NOT for self-swabbing, must be swabbed by trained personnel, were not for asymptomatic people nor for mass testing use so:

- the then Secretary of State for Health said "OK, the DHSC are now the manufacturer"

- the DHSC/Secretary of State for Health asked the MHRA to change the terms of use to cover self swabbing, no medical supervision, no symptoms required, mass use

- no technical stuff nor trials done to confirm they could do this accurately nor reliably

- MHRA said "OK, just make sure you change the instructions"

And hey presto - new official new DHSC LFD test approved for mass, self swabbing asymptomatic people.

No wonder the MHRA didn't want to release the document.

That is unless I've misunderstood it at first read through and I'm completely wrong which I don’t think I did.

From the MHRA letter to the DHSC (who had admitted to me in FOIs that the tests were the same and that they had supplied zero documentation to the MHRA to justify the repurposing):

 MEDICAL DEVICES REGULATIONS 2002 

AUTHORISATION OF SPECIAL USE OF DHSC COVID-19 Self-Test Kit 

I refer to your e-mail dated 14/12/2020 in which you requested special approval to supply the above non-CE marked medical devices on the UK Market, on the basis that a duly justified request has been made and this is in the interests of the protection of health. The reasons for the application cited 

“This submission is for an antigen based self-test swab kit which we believe is critical for the National Testing Programme in order to scale up our testing capability and bring testing to communities and groups without current easy access to testing to identify individuals that are infectious with COVID-19”. 

Based on this confirmation, the Secretary of State acting as the MHRA is satisfied that the request is duly justified, and that it is in the interests of the protection of public health to authorise the supply of the device under regulation 39(2) IVD of the Regulations, subject to the conditions set out below: 

The conditions were just as I stated above - change the instruction leaflet inside the packaging, tell us if things change and to:

That DHSC implements a Proactive Post Market Surveillance plan to survey user experience 

Total lack of regulatory oversight by the MHRA yet again.