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Might be quite telling how soon after MHRA sign-off, 'Add to Basket' appears on the Avacta website. Similarly, how soon Medusa offer an Avacta option.
I’m not saying that they’re at this stage, but in the presentation PresAl suggests the steps needed for home use approval are a lay user study and some additional paperwork. Medusa ran a lay user study recently so if that was what we all think it might have been - it was completed to MHRA guidelines - then it might not be too long. I don’t think they’d wait for this to give approval, after all they approved Innova, I’m just waffling that we might be reasonably close to CE marking for home use and genuine approval. By reasonably close, I mean months away - I’m using the Presalian calendar.
Boris has told Alistair that if he sells AffiDX in Europe before the UK he will chop his balls off.
Why is this a silly thread “oh all knowing” rocquet? Was a genuine question on why the test is not on sale in Europe given there is no need for conformity assessment in Europe. The MHRA involvement is for uk market only which AS said access to was only via govt. So wondering why it’s not on sale to Europe.
What’s silly about that? Would love your opinion o wise one!
Yeah agreed, I think he was full of bs too. Conveniently it was a call which can’t be verified. Whenever I ask on their web chat I get the same stock response of not available me yet, check Avacta website etc with no timeframes.
Jdt I've contacted Medusa in the past they've always told me to refer to Avacta website so I think Simon was talking bs
Hi muck. Agreed there must be a logical explanation.
Just in relation to your points. The MHRA can only provide this service for products going to the UK market regardless of home or professional use. So the lack of an EU notified body suggests we are going for professional use only in Europe.
I think as scaredy said, either for the sake of (what we thought would be a few days to get MHRA approval) it’s easier operationally for distributors like Medusa to be allowed to sell to uk and Europe at the same time.
Or there is actually a good chance there is near term govt orders off the back of this. AS did say in the prezzo the only route to uk market t present is through govt.
Someone tweeted they had called Medusa the other day who told them early June to order Avct test and mid June delivery. (Take Twitter with a pinch of salt but if true adds to the govt theory)
Hopefully find out soon!
Sorry, extract is actually from q16
Hi JDT - I’ve been wondering about this too.
There’s loads of guidance on this within in the U.K, but I found this the easiest to get my head around -
https://ec.europa.eu/health/sites/default/files/md_sector/docs/covid-19_ivd-qa_en.pdf
In summary, this suggests to me that a notified body (like the MRHA) need only be involved if the test is intended to be used as a self test. That’s confusing, of course, because the RNS made clear that we are CE marking for professional use only???
From q17 in the link
The precise role of notified bodies for different types of products is described in the relevant legislation. For IVDs under Directive 98/79/EC, they are involved in the assessment of self-tests (intended for lay users) and certain high-risk devices listed in Annex II of Directive 98/79/EC17. For COVID-19 tests, notified bodies are not involved in conformity assessment of tests intended for professional use, as these are not listed in Annex II. However, they do have a role for COVID-19 self- tests (i.e. those intended for lay users). For these tests, the manufacturer must submit an application to a notified body for the assessment of the design of the device, e.g. the suitability, for the lay user, of handling and information included on the label and instructions for use. Following a positive assessment, the notified body will then issue an EC design-examination certificate18. The assessment is usually by document review and not by physical testing of the device.
Notified bodies are not responsible for affixing the CE marking on the device, as this is the duty of the manufacturer. Notified bodies only issue the certificate for the specific activity that they have carried out. For a COVID-19 self-test, the manufacturer will not be able to affix the CE marking until the notified body has issued the relevant EC design-examination certificate.”
There is no doubt an obvious explanation, I just don’t know what it is!
Interesting thought jdt. It's crossed my mind over the last few days, whether or not we're allowed to sell to Europe right now, regardless of MHRA rubber stamp. You've confirmed that in theory we could sell to Europe now, so why haven't Medusa, for example, got the product available on their website, with the proviso 'Not currently for sale in the UK'? Could be an admin thing, as you allure to, along the lines of why mess about with mixed signals for the sake of a few days...just wait for MHRA.
On the other hand, maybe AS is faced with a bit of a balancing act. If there's a reasonable/credible possibility of UK govt saying (after MHRA sign off), great we'll take everything you can make, it might explain why AS can't give Medusa the green light right now (or indeed advertise the test on it's own website), since he has to wait for that govt decision. If it's a positive from the govt, presumably Medusa would have to be put in a holding pattern, assuming the agreement between Avacta and Medusa gives Avacta priority on available manufactured goods, until such time as Avacta have surplus stock available (or, Medusa have their own manufactured stock available).
Sorry wrong snip from gov site. Meant to paste the below
Conformity assessment
The results of mandatory conformity assessment carried out by UK Notified Bodies are not recognised by the EU. This is the case even if the assessment was carried out before 1 January 2021, unless your product had already been placed on the EU market before 1 January 2021.
Where allowed for under the relevant legislation, you can CE mark your medical device on the basis of self-certification for the purposes of the EU market.
Below taken from govt website. Mhra conformity assessment doesn’t apply in EU only for product on UK market. No mention by Avct of an EU body being required so product could in theory be sold today in EU. Yet we are waiting on MHRA approval before putting product on the market full stop.
Must be a reason for this - just can’t quite fathom what it is? As simple as it is less admin to say to not have to exclude markets from say Medusa site, or more to it?
CE marking for the EU market
To place a device on the EU market you must adhere to the relevant EU legislation and affix a CE mark to demonstrate compliance.
The UKCA mark is not recognised on the EU market. Products currently requiring a CE marking will still need a CE marking for sale in the EU.
If you use a UK-based Notified Body to conduct any mandatory third-party conformity assessment for your device, the following will apply:
if your device was placed on the EU market before 1 January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market
you are not able to place a device on the EU market unless it has been assessed by an EU-recognised Notified Body