there is a reasonable chance that the person who supplied the information in the older thread is still around, will read Nono's question, and might be able to find the thread quickly.
In my experience, and considering the characteristics of the traffic here (especially in the last year or so), this is quite unlikely to happen. My point in that context was that maybe the answer could have been found through a simple search, so I would have expected that before I put
my time into finding it for someone or rewriting it or re-researching it.
The trick is to find someone who has the information you need readily available. This is always something of a role of the dice, but the only way to find them is to ask around.
Yeah, I guess one can approach a person who has a brick of gold in their possession, "readily available", and ask them to give it. Roll of the dice, but it might work. The only way to find out is to ask.
I referred Nono to Erik because I thought there was a reasonable chance he would have the information readily available. As far as I can tell, he's been deep into the MDR virtually full-time for at least the last two years. He's published extensively about it on his blog, presented at conferences. This strikes me as just his kind of question--legal in nature, fundamental, and one that virtually every device company with a catalogue of MDD-certified devices needs answered, so a good chance he's dealt with it before, perhaps more than once.
I agree that Erik is a perfect choice in this context. I also happen to know him to the extent that I believe he is likely to provide a satisfactory answer, insofar as the OP's
knowledge is concerned, probably free of charge, if asked a direct question. However, since you brought up the issue of legal liability, in order to transform that "good" answer to a legally-beneficial instrument, a formal engagement and a formal issued opinion would be required, and I believe even Erik wouldn't provide that free of charge or in a matter of minutes (or even hours). If the legal utility of the answer is not of much interest to the asking party, it comes back to perceived expertise - how much the OP trusts the source.
Even if the issue becomes a court case, at the end of the day it all sums up in liability coverage. Suppose that the OP's company places a device on the market illegally, because they trusted an officially/legally non-qualified opinion, gets caught and eventually suffers some economical loss (because they didn't have their legal a$$ covered). They could still sue the source for damages,
but only if the engagement was formal. That's what I meant when I wrote "with the resulting liability and assurances". And that usually involves payment, regardless of who the expert is or what their qualifications (formal or otherwise) are. Expecting full accountability from anyone, in the context of informal volunteering, is unrealistic, whether your exchange is with a qualified lawyer, an experienced RA consultant who's not a lawyer, or just anyone contributing in good faith. Either way, if I engage a client, provide bad advice, they get caught and have to pay for it, I will also likely have to pay for it. That's why consultants take liability insurance. The alternative to that sort of setting is scrapping the entire RA consultant profession, with the exception of those who are licensed attorneys. I'm not one. I suppose you're not one either. And so are most of the RA consultants I know.
I don't understand the distinction you make between "legal" and "regulatory". To me regulatory is a subset of legal, and the reason I practice "regulatory" while I try to steer clear off "pure legal" is that medical devices RA seem to require more than just legal knowledge & skills - sometimes it's engineering, sometimes it's clinical, sometimes it's manufacturing etc. The point is that usually "a devices lawyer" wouldn't have a full skill-set either, only their shortcoming would be at the other end. I think that regulators understand that very well, and hopefully manufacturers understand it fairly well too. Whether the courts understand it, I do not know (I have never been in a situation that put it to the test, gladly). That's why it's still possible for individuals who aren't licensed legal practitioners to deal in matters that, in a sense, come under the "legal" umbrella; not "regulatory" being materially different from "legal".
This puzzles me. If someone posts a question in a forum, I don't see any reason to think that they expect an answer. Many people find answers here and in other forums, so, to me, if someone has a question for which they need an answer, it makes sense to ask the question here and in other forums, without any expectations. Perhaps some people do expect an answer, and even that others will invest time in getting it for them, but that's irrelevant to me. If I want to pursue their question, I do. If not, I don't.
Good for you.
What happened in this particular case was that
@Nono asked an opening question which I briefly answered. So far so good. Then @loko (possibly a different user) asked a follow-up question
directed personally at me. Still quite benign, so again I answered briefly. Then @loko elaborated and asked another follow-up question, again
directed personally at me, and that's where I started getting the feeling of some expectation, which triggered this whole off-topic discussion. I made it a point to respond (not necessarily as @loko wished for) because it's not just about what
placing on the market means or what the authoritative references are, and this is not an isolated case.