Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
You verify the product works before you commit to clinical validation. Any changes have to be re-verified, and an assessment made whether the clinical validation is impacted.
Each manufacturer would have to verify that their manufacturing process meets the requirements and that they are able to make reproducible/equivalent product.
The LFT to market must be very urgent. All of the technical documentation and product paperwork and in particular packaging, cartons, instructions for use will need to show the Mologic name and address, then be changed to Avacta when they are ready. A lot to do for a couple of days/weeks.
On the other hand, Government tender specifies that the LFT must be CE marked. which would then be mainly badged under DHSC branding, packaging, cartons and IFUs, with only minor reference to the actual manufacturer. interesting.
For professional use the product is self declared for CE marking. The product is then registered on the medical devices database. This is a formality - you pay your fee and the product is registered.
Boson Xiamen. I cannot see that it is self test. It says MHRA registered which is not the same as approved. All IVDs have to be registered - you pay your money and you register your product.
Same directive, same guideline.
Self test should be simple enough to use without training.
Professional use (EU/UK) means someone who is trained to use and interpret the device. Training could be a quick 15 minute demonstration and interpretation should be straightforward.
Self test or lay person use means someone who would be expected to use and interpret the test with only the instructions for use
The extent of the clinical validation is probably dependent on who is likely to review it - which country authorities. In Europe for professional use the manufacturer self declares for CE marking. For self test, with additional lay persons trials, the technical documentation would be reviewed by a notified body to apply CE mark for self test.
A clinical validation needs to be fully defined up front in a protocol, and approved by ethics committees. it would describe the aims of the study, who is performing it, who is monitoring it, and things like the statistical validity of the sample decided. Once it is approved and started, any deviations would need to be justified, all data generated would need to be included. The report would be based on the protocol and follow a prescribed format.
I don’t know what everyone is moaning about. I would be concerned if I thought Sir Al was going to be running the supply chain with a spreadsheet.
Our little minnow - a virtual manufacturer with none of the usual infrastructure for medical devices, has been developing through Cytiva, ex GE Healthcare and Whatman, manufacturing through BBI and Abingdon Health and now Mologic with GAD distributor network, all the best in the UK, and talking to other manufacturers to meet global demand.
Medusa19 is putting in global e-commerce, logistics and customer support, (and you need customer support for Consumer/lay tests). They may even be providing some manufacturing outsourcing - all controlled through their recently acquired ISO 13485 certification. Whenever I have been concerned through very poor information and missed timescales I have checked out the Medusa19 website and Saturn Pass website. They have not wavered - they have their crap saliva antibody test which I seriously believe that they have used to trial their systems and have never dropped Avacta and gone for other Antigen products
I have never bought anything from Boohoo and I never will. I buy from M&S, and Boohoo, started in 2006, is now bigger than them. Kamani Is the e-commerce wizz and Richard Hughes was the founder of Zeus Capital and among lots of others, Crawford Healthcare so he knows what MD systems are necessary..
I keep putting more Money into Avacta. The more I see, including the Medusa19 tie-in, the more I believe that this will come brilliant.
I may be wrong, but it is me and a couple of astute billionaire businessmen as well.
GLA
1 by 1, by 2 - unless Wilson has escaped the ban.
Saturn pass is raring to go as well.
www.saturnpass.com
Requirement to provide a response in 15 mins or less
Any manufacturer who places medical devices/IVDs on the market in EU or UK have to meet the requirements of the directives. For IVDs the majority of products can be self declared, as long as they are for professional use. A small number of IVDs are named specifically for notified body to verify conformance, along with any self test products.
For the time being UK is continuing to use EU directives until we have our own similar legislation
Clinical validation is the last part of the product requirements and clinical data is recorded on Instructions for Use as part of product claims.
UK government bid required that products were CE marked - in line with regulations, I assume to cover their backsides, but if the government decide to ‘NHS brand’ the products they are taking responsibility for the products and can use their own instructions
Damn - I have never seen the test, but I didn’t see anything in the IFU
Sorry for getting over excited, remembering gov funnel bids last year.
Did anybody else see funnels being used to add the sample to lateral flow test - that isn’t Innova or anyone else’s that I am aware of.
Is it us?
This ticket and test scenario was quoted in the Huffpost article.
It should also be noted that Medusa19 Saturn Pass app is being developed to support businesses and venues, not just reporting back to test and trace
Professional use - used by someone who has been trained to use and interpret the test.
Self test, or lay person use - used by someone who has no training to use or interpret the test.
The additional requirement for CE marking for self test is for lay person trials to ensure that a wide range of untrained people could use and interpret the test just using the instructions for use. It is also reviewed by a Notified Body to certify the CE marking.
If the government/DHSC takes responsibility for the instructions and it is under their ‘brand’, the legal manufacturer is not placing it on the market and my understanding there is no CE mark
Medusa19 updating their website. They are getting ready for something.
With the Innova rebadged products, are there any CE marks?
AffiDx trademark was filed 06/08/20 - I think it is us
Thanks for that Richob. I am really looking forward to the rocket.