You could say all of that of other things e.g. the MDR, where the end result in practice is complete crap. The system of "notified bodies" is commercial bureauc

You could say all of that of other things e.g. the MDR, where the end result in practice is complete crap. The system of "notified bodies" is commercial bureaucracy with random efficiency. If an agency wants to audit me, just dot it. The FDA does, with lower delays than commercial EU notify bodies... (right now the EU is accumulating more and more years of delay on putting medical devices on the market, even locally developped)