The "set of conditions" now appears to be a contractual agreement with your competitor to allow you complete access to their technical documentation indefinitely.
Well, the way I see how the requirement was written is that "your competitor" is not a good source for using clinical data, so if you reallyyyy want to do this, even is to do it in a way in which you are in practice the competitor (and yes, I understand this will not be possible in maybe 100 % of the time, but it seems to me that's the idea).
With all due respect, Marcelo, you don't see a problem with barriers to innovation & competition, and perpetually increasing healthcare costs?
I see problems with manufacturers not doing what I understand is technically correct, independently of any regulation. The bypassing of clinical investigations by using a mixture of different competitor devices as equivalent has never made sense to me, but it was always accepted (and people equals "acceptance" from a regulator/notified body/certification body and the like as being technically correct, which is also wrong). Now it's not accepted anymore. So in my opinion this only correct the wrong application of the old regulations.
Sorry, just frustrated with continually expanding regulations and some of the justifications. Sure, we want to assure a certain level of safety - I get it. ...but it is the dismissive "I don't see a problem" attitude from many proponents of increased regulations that makes it feel like the other side of the ledger is often completely ignored. The potential consequences are just hand-waved away...
Rant over. Apologies.
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P.S. No offence to you personally, Marcelo. I'm pretty certain I've just taken an un-nuanced snippet of what you said, and used it as an opportunity to pounce on my personal pet-peeve. Can't resist the rant...
I don't take things personally in relation to work, if I did, no one that I've known would talk to me anymore
On the other hand, proponents of requirements and regulations (and I'm part of these, either by participating in standards development or the regulation creation itself in some instances) do take into consideration implications, and usually they are taken into consideration in the due process. However, I also understand that small manufacturers (which are most of the manufacturers in the world) may not be fully represented or be heard in a way they wanted.
As I come from a development country where most of the manufacturer are small, and they are my main clients, and in my different roles, I do try to represent their views as much as possible in the discussions, including international discussions, that I participate, but there's no way to bypass the fact that medical device safety and effective are a complex topic, and unfortunately most of the small/medium sized manufacturers are not aware or cannot fulfill all the expectations.
Finally, and this is a common problem, I understand the rant but anything done afterwards is not much effective. Those rants and comments should to thru the proper channels prior to the publications of final rules (as I mentioned, I understand the difficult of of doing this for most of the stakeholders, unfortunately).