Sorry, but I couldn't help myself. I was too puzzled and had to dabble into some Googling.
Legal process to obtain CE mark and associated fraud risks "
According to IVD Directive 98/79/EC, to affix the CE-mark to COVID-19 diagnostic devices to be used by health professionals, the manufacturer has to specify device performance characteristics and self-declare conformity with the safety and performance requirements listed in the Directive. In contrast, self-tests intended to be used by patients themselves must also be assessed by a third party body (a notified body). The dedicated Commission working group of Member States competent authorities for IVD serves as a forum for continuous exchange of technical and regulatory information on IVDs including COVID-19 rapid tests. While the majority of CE-marked rapid tests are compliant with EU law, the group has identified several devices with fraudulent documentation, incomplete technical files or unsubstantiated claims. Some of those were sold as alleged self-tests. Several Member States have warned against the use of rapid self-tests or even prohibited them."
https://www.ecdc.europa.eu/sites/default/files/documents/Overview-rapid-test-situation-for-COVID-19-diagnosis-EU-EEA.pdf
I am not saying that something is fraudulent. What I am trying to say is that in order to put a CE mark on your product, if you have ISO13485 (which is required for companies that want to market medical devices) you can basically self-declare conformity and you have the right to put the CE mark on your product. What happened early on in 2020 is that some companies put the CE mark on their products and marketed them as self-tests. This is illegal. The announcement from DOTZ does not seem to say that the product is a self-test, so if it is a product for health professionals all that the manufacturer has to do is to declare that the product conforms with the EU safety and performance requirements and notify accordingly.
DOTZ I cannot find any information on Dotz receiving ISO13485 on its website or the specifics about its CE marked products. From the announcement, it seems to rely on Systaaq ISO13485 for its "approvals". In order to obtain a CE mark, as per above, Systaaq could declare that it conforms with the EU requirements as it is the manufacturer, but it will be Systaaq's product, not Dotz's and Systaaq would then bear the responsibility for it. If you look at the FDA template for EUA, you will see that the details of the applicant and the details of the manufacturer need to be inserted. The applicant then is the owner of the product and then it makes sense that Systaaq is only doing contract manufacturing and would be registered as the manufacturer. As the applicant who is responsible before the FDA for the data and the safety and efficacy of the product, I would expect that the business must met necessary requirements to supply medical devices (such as ISO13485). Note that both Atomo and AnteoTech are ISO13485 certified.
SystaaqWhen searching Systaaq, only one medical device product is registered for export with FDA in 2021:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfmAnd only one product appears on the EU covid test database:
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/395You will see that no data is provided on sensitivity, specificity or analytical specificity (Limit of Detection). References to details are linked to a product description of another company. If you look at Systaaq website, you can see its conformity declarations for its products:
https://www.systaaq.com/wp-content/uploads/2020/03/DoN-SYSTAAQ-2019-Novel-Coronavirus-COVID-19-Multigene-Real-Time-PCR-Kit-Merged.pdfhttps://www.systaaq.com/wp-content/uploads/2020/03/DoN-SYSTAAQ-2019-Novel-Coronavirus-COVID-19-Real-Time-PCR-Kit-20200624-2-merged.pdfYou can see from these documents that once the declaration of conformity is done in-house (as in this case), and then it is sent to some private company to notify a notified body within EU (in this case they choose Belgium, which I noticed a lot of Chinese manufacturers seem to choose too). Note that it is just a notification, no need for any approval. So just like this, the product can have its CE mark.
If the test is a self-test, it will need to be assessed by a notified body. The announcement did not make any details on whether it is a self-test and who is the notified body. One thing a shareholder could do is ring the company and ask to see the CE, since it has been announced to the market already.
I hope this helps someone carry out their own research if they are interested in these topics. All above is IMO only, and I know nothing.
