Background of Annex X section 1.1d of MDD 93/42/EEC

Ronen E

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#51
And as I said before, even the particular standard requires clinical investigation, so the "well-established" here does not make much sense.

And this example is exactly why I worry about the "well-established" part. For a device manufacturer or someone without a deep knowledge of the device requirements (including standards) the "well-established" argument may seem good. But if the evaluator has a good knowledge (in this case the only needs to read the particular standard), this argument falls off quickly.
I think that there's no inherent problem with "well-established". The problem in this specific example is a badly-written / outdated standard. This needs fixing.

As the MDD says, placing a device in the category where a clinical evaluation is not necessary needs to be duly substantiated. To me that means that a manufacturer can't go by gut feeling - they need to study the background and gain that "deep knowledge" you mentioned. Is it less onerous than preparing a clinical evaluation (either with or without an investigation)? I don't know, the manufacturer should evaluate that and decide.

Last, for really well-established device categories there's usually a wide range of sources that can be relied on (books for example), even to the extent that you can show that a single source is an outlier.
 
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Marcelo

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#52
In my experience it's not difficult to find equivalents for pluse oximetry, but maybe there was something unique about the device you worked on. Again, the question is "well-establishlished" vs. novel.



If you ask for my opinion (and you probably don't...) it's an overkill. Unless that standard is old, I don't see why it should prescribe a clinical investigation for a pulse oximeter. None of the leading regulations are that prescriptive. Anyway, applying a standard to show compliance is a matter of tactics. It's not mandatory in most cases, and even if a standard is chosen for implementation, there's no obligation to implement all its parts. The manufacturer should consider the implications and decide. "Is conducting a clinical investigation more onerous than showing compliance without the standard?" etc.
It's the last edition of the standard, and the revision is putting even more stuff on the clinical requirements.

I think we are talking about different stuff here.

You do seem to be talking about technology, not devices.

For a device, independent of the technology being new or not, we do have to verify if the device does what it says it does. Clinical data is usually required to show that. So it's a very good practice, and that's why the standards require that also.
 

Marcelo

Inactive Registered Visitor
#53
Last, for really well-established device categories there's usually a wide range of sources that can be relied on (books for example), even to the extent that you can show that a single source is an outlier.
Again, these comments do seem to be about a technology, not a specific device. We are really talking about different stuff here.
 

Ronen E

Problem Solver
Staff member
Moderator
#54
You seem to be implying here that your device uses well-estblished technology.

Please note that the clinical evaluation is about your device, not your device technology. So, the question is, is your device well-established? And this is the problem with the "well-estblished" thing (in fact, it seems to be a confusion in the whole discussion, because of the thinking about device technology, instead of the specific device).
I respectfully disagree.

The whole "well-established thing" (as you refer to it) is not in the MDD text, but rather something that people say/think about the authors intention. Surely we don't know if "well-established" qualifies the technology or the device itself. We don't even have that intention in writing... at least as much as I know.

It's true that a clinical evaluation is intended to be device-specific, but that clause relates to a situation where the clinical evaluation requirement is void. Again, think of cotton tips. The specific tip doesn't need to be well-established, as long as it belongs in the general category, which in itself is well-established.

Additionally, it's not only "well-established". It should also be "low risk". I (and probably you too) have been using the shorter term for convenience, but maybe that's a mistake. Maybe we should refer to WELR instead.
 

Marcelo

Inactive Registered Visitor
#55
Regarding the pulse oximeter example, the standard in full is recognized by the FDA.

Also, the FDA guidance on pulse oximeters also expects clinical studies to determine accuracy of SpO2, the same things in general that the standard requires.
 

Marcelo

Inactive Registered Visitor
#56
Surely we don't know if "well-established" qualifies the technology or the device itself. We don't even have that intention in writing... at least as much as I know.

The current MEDDEV does mention in a lot of places well-established linked to the device under consideration:

6.2.3 ...whether the device is well established, ...
9.2 ... For many well established devices and lower-risk devices, qualitative data may be adequate to fulfil the requirements of the MDD and AIMDD
A12...he timing and frequency of the notified body reviews will vary according to the risk carried by the device, how well established the device is (see Section 6.2.3) ...
And there's one instance where it does clearly mention technology

7 - Similarly, it may be possible to use compliance with harmonised standards to satisfy the clinical evidence requirements for devices based on technologies with well established safety and performance characteristics.
 

Ronen E

Problem Solver
Staff member
Moderator
#57
For a device, independent of the technology being new or not, we do have to verify if the device does what it says it does. Clinical data is usually required to show that. So it's a very good practice, and that's why the standards require that also.
This is an inefficient approach, and so in my opinion not "a very good practice". If the device has a "me too" design, which is usually the case with WELR devices, there's no need to reinvent the wheel. Equivalent devices (or the technology in general) have been verified clinically, we copy them/it, end of story.
 

Marcelo

Inactive Registered Visitor
#58
This is an inefficient approach, and so in my opinion not "a very good practice". If the device has a "me too" design, which is usually the case with WELR devices, there's no need to reinvent the wheel. Equivalent devices (or the technology in general) have been verified clinically, we copy them/it, end of story.
???

Well, that seems to me to be totally different from what the current MEDDEV guidance expects. I understand what you is trying to say, but the the idea is exactly to have clinical data that shows that your specific device works. If there's an equivalent (which was made much more difficult in the last MEDDEV) and clinical data related to the equivalent which is deemed good enough to show compliance, you can use it, but if not, the only option is to create clinical data thru a clinical investigation.
 

Ronen E

Problem Solver
Staff member
Moderator
#59
Regarding the pulse oximeter example, the standard in full is recognized by the FDA.

Also, the FDA guidance on pulse oximeters also expects clinical studies to determine accuracy of SpO2, the same things in general that the standard requires.
Standard recognition by FDA means that it may be used to show compliance. It doesn't mean it has to be followed. FDA guidance is not legally binding too, they state it at the beginning of all contemporary guidance documents. The FDA allows "the least burdensome approach" - if you can show compliance in a way that is less burdensome to you than the one they suggested in a guidance, that's acceptable. The only exceptions are when a standard or a guidance are made mandatory under a Special Control.

More generally, the FDA doesn't mandate, across the board, clinical evidence for class II/I devices.

Either way, all that's a little besides the point because we were initially discussing an MDD clause, and at that, the general principle rather than a specific device category.
 

Ronen E

Problem Solver
Staff member
Moderator
#60
The current MEDDEV does mention in a lot of places well-established linked to the device under consideration:

And there's one instance where it does clearly mention technology
I was referring to the MDD itself and to the intention of the 2007 amendment authors. That text has been written >10 years ago, and those have not been without a lot of technological and regulatory change. The current MEDDEV interpretation is a very important one, however, it is that - an interpretation (and don't tell me that it's the current de-facto regulation - I know :().

Either way, I don't think that the phrase "well-established device" should be read in the literal, limiting way you suggest, and the language itself doesn't rule out my approach. What is a "well-established device"? Is it only a device that has been in (wide) actual use for long, or is it also one that copies/mimics methods/designs/principles that have been in wide use for long?
 
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