Remarkably, in the UK, it is still currently possible for anyone to set up in business and call themselves a medical diagnostics company, distributing medical tests directly to the general public, or through retailers - and we saw a lot of opportunism during the Covid pandemic.
Indeed, just as the pandemic was starting to wane, we were inundated from would be diagnostics companies asking for own label brands of our SELFCHECK products (which we declined). Whilst we should encourage entrepreneurship, there must be a line drawn for a minimum standard for suppliers of medical products.
There is already an international standard for medical device distributors, called ISO13485:2016, and a system in place for manufacturers to be independently audited and certified to this standard through UKAS certified auditors, albeit at a relatively high cost.
As a research focussed medical device company, we had no hesitation to invest in the resources required to attain an ISO13485 quality assurance system and certification by UKAS certified auditors right away, and have been for almost 6 years.
Surely, it is in the public interest (and of the major retailers) that all UK companies that call themselves medical diagnostic distributors do the right thing, and invest in this quality assurance standard as a minimum?