RE:EU-CE Approval???? The Scientist, the system for approving and/or authorizing devices in the EU is disjointed and hard to follow at best. While there are specific expectations for this and the subsequent CE mark that would be part of the packaging of any device, including AcuVid, there is no complete, central location for identifying such devices.
The following is from a link on an EU Q&A concerning covid devices. From what I have read there are very specific legislations covering the manufacture and/or selling of devices in EU member countries. But there is no direct approval or authorization process.I would speculate that THRM would have had to meet these expectations to apply for approval to apply the CE mark to AcuVid ...which appears similar, yet different, from, for example, the FDA EUA.
"5. At the moment, there is no exhaustive public EU database of CE-marked in vitro diagnostic medical devices on the market in the EU Member States."
https://ec.europa.eu/health/sites/default/files/md_sector/docs/covid-19_ivd-qa_en.pdf
If one goes back and reads the original NR it states "The EU declaration of conformity indicates that the AcuVid™ COVID-19 Rapid Antigen Saliva Test complies with all the requirements of European IVDD (in-vitro diagnostic device) legislation.
This declaration reads "An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law."
https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm
To alleviate any concerns, THRM can't lie about approval. While the choice of that word has connotations and probably shouldn't have been used based on EU protocol, it in no way detracts from the fact they are able to manufacture and sell AcuVid to EU member countries as they have met all the obligations and expectations through the legislative process to do so.
Cheers, GLTY and GLTE ...patiently holding long!!!
TheScientist01 wrote: not trying to bash here coz I'm still holding 100k and hoping for this to break out. I understand that this isnt listed on HC website because they havent started testing in Canada.. Therma said they received EU-CE approval and CE only conditional sale... Soooooo why isnt this listed on the EU-CE approved covid diagnosis devices?? Anyone have any ideas? The website would have been updated by now coz its been over a month now. check it out and let me know.. im curious what you think. https://covid-19-diagnostics.jrc.ec.europa.eu/