Is MDR Article 61(5) Unrealistic?

Mark Meer

Trusted Information Resource
#1
Maybe I'm misinterpreting the intent behind Article 61(5) of the MDR, where it says:

5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:
  • the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis
...
When does this ever happen? Why would a (competing) manufacturer ever sign a contract with their competitor to give them "full access to the technical documentation on an ongoing basis"?

This clause just seems strange and unrealistic to me... Am I misinterpreting how this might be applied in practice? Thoughts?
 
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Marcelo

Inactive Registered Visitor
#2
My impression is that this was created to prevent as much as possible a manufacturer using devices from other manufacturers as predicate.

Part of the problem of the application of the MDD was that manufacturers of high risk and implantable devices did not perform any clinical investigation by claiming equivalence to other devices and then only doing a clinical evaluation without real clinical data. The revised MEDDEV (specially the revised equivalence "requirements") and this will in practice require that manufacturers do perform clinical investigations, unless they have a equivalent device of their own.

As ons of the basis for the revision of the directives was an approach to require more clinical data, this seems to be following this approach.
 

Mark Meer

Trusted Information Resource
#4
My impression is that this was created to prevent as much as possible a manufacturer using devices from other manufacturers as predicate. ...
I think it does what it is intended to do! :)
This seems a shame to me... that they'd effectively block a route to conformity by imposing an essentially unobtainable requirement.

I understand the intent...but why not just bump up the threshold of evidence to demonstrate equivalence (something that doesn't require contractual access to a competitor's technical files) - especially in cases where the technology is generally well established?

There are presumably many startup initiatives that will simply be priced out of the market now, as there is no alternative but to carry out clinical investigations. In the long term all this will do, IMO, is create barriers to competition and drive up device/healthcare costs.
 

Marcelo

Inactive Registered Visitor
#5
This seems a shame to me... that they'd effectively block a route to conformity by imposing an essentially unobtainable requirement.
It's not unobtainable...you can use it under some set of conditions. In fact, this is much more consistent with other regulatory systems.

There are presumably many startup initiatives that will simply be priced out of the market now, as there is no alternative but to carry out clinical investigations. In the long term all this will do, IMO, is create barriers to competition and drive up device/healthcare costs.
This has always been true for other regulatory systems in general, so I don't see it as a problem per ser. Innovative medical devices without a clear benefit/risk profile were always required, in general, to go thru more stringent regulatory approval processes.
 

Mark Meer

Trusted Information Resource
#6
It's not unobtainable...you can use it under some set of conditions...
That's why I say it's effectively unobtainable. The "set of conditions" now appears to be a contractual agreement with your competitor to allow you complete access to their technical documentation indefinitely.

Seriously, how often do you think this condition is obtainable in practice?

...This has always been true for other regulatory systems in general, so I don't see it as a problem per ser. Innovative medical devices without a clear benefit/risk profile were always required, in general, to go thru more stringent regulatory approval processes.
With all due respect, Marcelo, you don't see a problem with barriers to innovation & competition, and perpetually increasing healthcare costs? Where is the "clear benefit/risk profile" when it comes to imposing new regulations? Is there hard (non-anecdotal) data to show that allowing manufacturers to justify equivalence and clinical evidence from a predicate leads to more harm? Or is it just an assertion that preventing this route to market necessarily leads to better healthcare? How would one even go about calculating the opportunity cost of the reduced innovation, competition, and higher prices?

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. :eek:

---
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... :notangel:
 

Marcelo

Inactive Registered Visitor
#7
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.

---
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:p

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).
 

tazer

Involved In Discussions
#8
With all due respect, Marcelo, you don't see a problem with barriers to innovation & competition, and perpetually increasing healthcare costs?
I would say that it is rather fighting against unfair competition. It is unfair that the first on the market is obliged to perform a clinical investigation, while the following have only to use its results (without knowing them) without any contribution.
 

Mark Meer

Trusted Information Resource
#9
I would say that it is rather fighting against unfair competition. It is unfair that the first on the market is obliged to perform a clinical investigation, while the following have only to use its results (without knowing them) without any contribution.
Fair point. But this seems incredibly inefficient, and shackles industry development. Do we really want organizations to have to reinvent the wheel - even in cases where there may be plentiful public data available on established predicate(s)? But, on the other hand, I see your point that it may not be fair that a competitor can leverage your presumption of conformity without having to do the same leg-work..

What is the value of being first-to-market? Does it sufficiently offset the cost of carrying out clinical investigations (thus negligibly disincentivizing innovation)?
Or, considering increasing requirements for clinical investigations, does the system simply create a pay-to-play climate where only huge organizations can afford to compete?

The ideal goal, IMO, is a system that balances incentives of innovation, competition, and safety...but there are obvious trade-offs. What concerns me is that considerations for innovation & competition have taken a back-seat to (perceived?) safety assurances, without considering the broader "safety" risks that come from reduced innovation (improved technologies) and competition (less cost, greater access).
 

TWA - not the airline

Trusted Information Resource
#10
I would say that it is rather fighting against unfair competition. It is unfair that the first on the market is obliged to perform a clinical investigation, while the following have only to use its results (without knowing them) without any contribution.
Well if the IP of their device is protected, then the competition can immediately use the clinical data but not really copy the product. If patents run out after 20 years, we are exactly where Mark's inital post started: a well established device with lots of clinical data that cannot really be used by the competition, which in effect protects the device longer (maybe even indefinitely) than patent laws do. This actually defeats the purpose of patents: that you publish knowledge that advances the state of art and as a compensation for some time you are granted exclusiveness on the IP you published.
 
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