No. I'm a software engineer for clinical studies and medical devices and this is not true for any medical device, which includes antigen tests, at all. Also these tests had a time limited special permit which ran out a few months ago, which is why they were able to be sold. here is a FAQ about antigen tests: https://www.bfarm.de/DE/Medizinprodukte/_FAQ/Antigen-Tests/f...
>Die Neubewertung hat ergeben, dass ein gravierender Versorgungsengpass und damit das Interesse des Gesundheitsschutzes an einer Sonderzulassung entsprechender Tests nach § 11 Abs. 1 MPG durch das BfArM nicht mehr besteht. Diese Bewertung wird ab dem 15. Juli 2021 für die Antragsbewertung aller laufenden und neu eingehenden Anträge nach § 11 Abs. 1 MPG zugrunde gelegt.
seems like you're up for a surprise.
PEI has been validating tests for months.
https://www.pei.de/DE/newsroom/dossier/coronavirus/coronavir...
https://www.youtube.com/watch?v=s157CbfS5xg&list=PLuiYhcgFTm...
> Unsafe Doctor waiting rooms
what source? it's trivial to verify. visit a couple of doctors in the city of a large German town and count number of people sitting in a room with special notice to those who are coughing and sneezing ...
> dubious testing kits
I'm not aware of systematic audits of test kits. In Germany a device is considered alright if it has a CE printed on it and maybe some other numbers. That's a usual source of many problems with food, toys etc. nothing new here. Also it's currently in the media that not all test kits respond equally to Omicron - so, it's not like they are standardized. They are now starting device specific audit to check for sensitivity.