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Re:Covid-19 may have killed nearly 3M in India, far more tha... by tloup on Monday January 10, 2022 @11:00AM (#29876794)
>In Germany a device is considered alright if it has a CE printed on it and maybe some other numbers.

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.

Re:Covid-19 may have killed nearly 3M in India, far more tha... by 2-718-281-828 on Monday January 10, 2022 @11:02AM (#29876830)