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When is "placing on the market"? MDD certified medical devices

Ronen E

Problem Solver
Staff member
Super Moderator
#11
I'm not an "EU device lawyer" and don't dispense legal advice in any capacity, but that's not the reason I didn't pick it up. I'm quite sure that if I had put my mind to it I could reconstruct my original "legal" argument quite solidly (not rocket science), but - no offence to anyone - I can't be bothered any more. People, I don't work for anyone here. It's Saturday morning in Western Australia now, and I'm volunteering at my own leisure.

In my opinion, if some user here has a non-trivial question they have two options:
1. Ask other users here to comment, pretty much off the top of their heads, based on their "expertise", and accept what they provide as exactly that - "expert" advice. Whether the "expert(ise)" qualifier is justified or not, each user should judge for themselves. If it is - that should suffice. If it's not - no amount of official references can change that (and they are likely to only confuse).
2. Properly engage and pay for properly backed expertise, with the resulting liability and assurances.

Asking people to volunteer their experience/expertise and then expecting them to fully back it up (as a proper expert would do in a paid capacity), with the only compensation being the overwhelming bliss of knowing that you gave a total stranger a present, doesn't really cut it. Not in my case.

Sorry.
 

Watchcat

Quite Involved in Discussions
#12
...legal advice..."legal" argument
I'm inclined to think that this question doesn't require legal advice or a legal argument, but an authoritative legal reference. A number of people have helpfully provided references, but I think an EU device lawyer would be a better source, not so much because of any legal expertise, but because I think they would be readily aware of the reference(s) that would best address the question, and could cite them off the top of their head.
 
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Ronen E

Problem Solver
Staff member
Super Moderator
#13
Good luck finding that knowledgeable lawyer who dispenses free authoritative answers to individual questions.
 

Watchcat

Quite Involved in Discussions
#14
authoritative answers
Not an authoritative answer, but an authoritative reference. If Erik knows of one, I'm expect he would not hesitate to provide a link. Or, as I said previously, if he has already addressed the question (which is being asked by an individual, but is general in nature, and therefore likely to be of interest to others) on his blog, to point you to it. Alternatively, his blog has a search function, so Nono might start there.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#15
1. The way I look at the regulatory reference-set, a reference is only authoritative to the extent you accept the authority of whoever provides it. To itself, the reference may be authoritative, but it is the authority of the answer (pointing to certain references) that actually matters. In most non-trivial cases I've come across, a solid argument would consist of not a single but a combination of references, some more and some less authoritative (e.g. regulations vs. official guidance vs. semi-official guidance etc.). The current question is a good example for that. Further, someone could be providing a very wrong, yet perfectly authoritative, reference (wrong as in not really applicable in a given case, etc.). Cases where all you need is a single, straightforward reference (e.g. Article this, section that, of the MDR), don't require much (or any) expertise and can indeed be answered accurately by many in <5 minutes, as they usually are.

2. I did not say that the information is not already out there. It definitely is, only it usually takes a while or some >0 effort to find it / collect it. It may even be hiding in plain sight - right here, buried in some older thread at Elsmar. My point is that either strategy requires a bit more than posting a message here and expecting someone to accommodate in the name of <whatever>.
 

Watchcat

Quite Involved in Discussions
#16
We seem to be talking past each other, for reasons I haven't been able to figure out. Regardless, I think we've reached the point of diminished returns. After this last post, I think I've said all I might have to say, so I'm going to try to move on:

The way I look at the regulatory reference-set, a reference is only authoritative to the extent you accept the authority of whoever provides it.
To me, that depends on the nature of question and the answer. If I think the information in the references addresses my needs and that the references themselves strike me as authoritative, then, for some questions, that may satisfy me, regardless of whoever pointed me to them. For other questions, not.

As I said, I think this is legal question, not a regulatory question. The word "legally" could have been appropriately included, but was not:

...which of the following conditions will be regarded as "placing on the market" in order to legally sell or use the device even after the expiration date?
For a legal question, the "authority" of the person who pointed me to them (and perhaps also explained why they were the appropriate references) matters. Whether their answers are "correct" or not is irrelevant. That would be for a court to decide, not me. If it turns out the information I was given was incorrect, I want to be able to say it came from the appropriate authority...in this case, a licensed attorney, because then the worst that is likely to happen is that I'll have to pull my devices from the market. However, if I can't show I did my due diligence, much worse things can happen, and relying on any authority other than a licensed attorney to advise me on a legal matter is unlikely to be accepted as due diligence. More likely to be suspected of an effort to avoid paying the fees of a licensed attorney.

IMO, this isn't just a legal question, but a critical legal question, because it determines whether or not the company's devices are legally on the EU market after a particular date. If a client asked me what I thought was a critical legal question related to the FD&C Act, I would point them to a device attorney as well.

In most non-trivial cases I've come across, a solid argument would consist of not a single but a combination of references,...Cases where all you need is a single, straightforward reference can indeed be answered accurately by many in <5 minutes, as they usually are.
That depends on what references those to whom the question is directed have at their fingertips. In specific areas in which I have a lot of experience (typically involving clinical evaluation of medical devices) I can sometimes put my hands on multiple references addressing a relatively complicated question, and explain how and why they address it off the top of my head, because the same question comes up frequently in my work.

right here, buried in some older thread at Elsmar.
And while the rest of us might have to expend significant time and effort to find it, 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.

My point is that either strategy requires a bit more than posting a message here
Mine is that what either strategy requires depends on what information the people who might pursue them have at their fingertips and on the tip of their tongues. 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.

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.

expecting someone to accommodate
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.

I personally didn't see anything in Nono's post that implied any expectations. only a question in need of an answer.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#17
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.
 

Watchcat

Quite Involved in Discussions
#18
this is quite unlikely to happen

That would be an interesting question, how long some Covers have been around. I've come and I've gone on and off since the late 90s, sometimes away for years. Always seem to find at least some old-timers still around.

In this case, it wouldn't take that old of a timer, because it's about the MDR. Nonetheless, by "reasonable" chance, I meant from the perspective of Nono's ROI. All things considered, reasonable enough to warrant asking, I think.

I agree that Erik is a perfect choice in this context.

For reasons you have already cited, possibly the only one.

in order to transform that "good" answer to a legally-beneficial instrument, a formal engagement and a formal issued opinion would be required...it comes back to perceived expertise - how much the OP trusts the source.

Yes, in the end, the company would have to decide whether it was comfortable going with Erik's answer, or felt it needed something more, and was willing to pay for it.

The alternative to that sort of setting is scraping the entire RA consultant profession

Heh. Some days I think things are going that way. As for my own strategy, I never sign anything and make no guarantees.

I don't understand the distinction you make between "legal" and "regulatory".

Ah, yes, the perpetual Regulatory identity crisis, a long-standing interest of mine.

I started in pharma, where the distinction is clearly marked, if not always easily articulated. A favorite articulation (if perhaps not the end-all-be-all in terms of distinguishing between the two) came from a conversation with a JD who started in Legal and transitioned into Regulatory. He said, "Legal steps in when RA fails." This evoked "War is the failure of diplomacy," and that's where we settled out: Legal is war; RA is diplomacy.

medical devices RA seem to require more than just legal knowledge & skills

I describe Regulatory as sitting at the intersection of Law, Medicine, Business, Government, Science and Technology. It is the most complex and intellectually challenging field I know of.

a follow-up question directed personally at me.

Ah, now I get it. I went back to take a look and now I think I mostly skipped over those two comments, as I was interested in the answer to Nono's question, and those two comments didn't seem to be leading there. So I missed the questions at the end of each comment and that they were directed at you.
 
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