Replies to post #94632 on Decision Diagnostics Corp (DECN)

[Jelly Bean]

CE mark is not equivalent to FDA.

Yeah, well its not equivalent to selling genviro out of the back of your car at a 7-11 either. You don't just get to say "CE certified" and start selling. Someone is going to jail if they do that and berman will be living in your head, rent free, for ever.

[rawman]

CE mark is not equivalent to FDA.

Ergo I do not expect any other countries requirements to be as rigorous as the FDA.

First of all, I was not responding to a message about a CE mark! Check YOUR posted quote. And second, "Ergo I do not expect" is an opinion and not proof unpinning the supposition!

It seems to have been missed, but there is a Eurporean Medical Device Review process, which is virtually identical to the FDA! Here's the first paragraph of the European Union regulation that was put in place on April 5, 2017.

1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.

https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05

The full text of the EU Medical Device regulation is 240 pages in length, with each member of the European Union having its own version of the regulation. The above link contains a PDF of every EU Country's specifics.