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No medical device from Avacta is registered on the MHRA database. I don't think an AffiDX LFT can be made commercially available until it is. And God knows when that will be. Check for your self.
https://aic.mhra.gov.uk/era/pdr.nsf/Search?SearchView&Query=/era/pdr.nsf/Search?SearchView&Query=[ManName]Contains(%22Avacta%22)&SearchOrder=4
There will be no Innova manufacturing in Wales. The Sharp "factory" is a bog-standard industrial warehouse in the middle of nowhere and it probably has 3 phase power to run the labelling machine.
From the Sharp UK website:
Our team at Sharp UK has been providing clinical trial supply packaging, labelling and distribution services since 1988. With ISO9001 and ISO13485 certification, we also offer support for medical device packaging.
The company contracted to manufacture the tests on behalf of Innova is understood to be Sharp, based near Newport in south Wales.
Sharp is a division of Dublin-based UDG Healthcare. UDG is listed on the FTSE 250 but is in the process of being acquired by US private equity firm Clayton, Dubilier & Rice.
Innova and Sharp struck the manufacturing deal in April, with the aim of making 7m tests a week, sources say.
Wrong...the UK was allowed a temporary transitional status until the MHRA has full legal standing. Following your logic means Avacta will not be allowed to sell into the EU at all.
I don't believe a company can sell any medical product in the EU until it's actually registered with a national regulatory authority....MHRA for us. CE is a step to getting approval.
Covid numbers are down but a majority of the population will probably have serious doubts about risking the fact in a tightly packed club or theatre or stadium.....without testing. The government will want a lot of stock for next winter and Christmas......the real trial for the UK.