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

Marcelo

Inactive Registered Visitor
#21
From the Oxford dictionaries:
Quote:
well established [adjective]
Firmly established, especially because of a long existence.
I was trying to say that there's no definition in the regulations that enable a clear, technical judgement.

There are many views for this exception. But I do not find a convincible one so far.
If there were clear, technical definitions in the regulations, the view would be more clear. Right now, it too open for interpretation. Even the MEDDEV does not help because it still do not say how we can "deem not appropriate to use clinical data".
 
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Marcelo

Inactive Registered Visitor
#22
Marcelo,

I understand that you are trying to use IVD devices / IVD regulation to clarify a point, but I think it creates a distraction rather than clarifies. This thread originated from an MDD clause, relating the (non-IVD) medical devices. IVD is a different world with its own use patterns and its own regulations (be it the IVDD or the IVDR).
Yeah, it was only to making a point, and I'm also mostly talking about non-IVD here, too.

I also think that non-IVD diagnostic devices should be treated more similarly to therapeutic devices than to IVD devices (and the regulation seems to "think" the same)
Agreed, but I think the problem is when we begin talking about the benefit and the link of benefit with clinical data, and maybe the real problem is exactly the old, "legacy" devices.
 

Ronen E

Problem Solver
Staff member
Moderator
#23
The only problem with the explanation "intended for well established and lower-risk devices" (and I've heard this many times) is that it's not technical and really not actionable.

So, can I use it for all class I devices? What is "well established"?

That's why I prefer an explanation related to the technical aspects of clinical performance and clinical safety. This way I can create a sound rationale.
The human mind can rationalise in both a deductive and an inductive way.

What I mean to say is that when you (or an auditor, or anyone) sees a "well established, low risk device", you know it from miles. A dry, non-sterile cotton tip is an example.

Can all class I devices be exempted? Probably not. But ones that apply the same design for over 30 years, and are still common (ie didn't cause a lot of trouble and weren't yet replaced by something much better) - in other words, are "well-established" and "low risk" - probably can. And in many cases there will also be well-established published standards to cover such devices anyway, so it all fits together nicely.

Does that eliminate grey area completely? Probably not, but that's the business. I think it's still quite workable.
 
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Ronen E

Problem Solver
Staff member
Moderator
#24
FWIW, 2007/47/EC (the 2007 amendment of the MDD) states in its preamble ("whereas section"):

(8) In the light of technical innovation and the development of initiatives at the international level it is necessary to enhance the provisions on clinical evaluation, including clarification that clinical data is generally required for all devices regardless of classification and the possibility to centralise data on clinical investigations in the European databank.
I couldn't find in that section more specific clues as to why the clause subject of this thread was introduced or what was the authors' intention in doing so.

:(
 

Marcelo

Inactive Registered Visitor
#25
The human mind can rationalise in both a deductive and an inductive way.

What I mean to say is that when you (or an auditor, or anyone) sees a "well established, low risk device", you know it from miles. A dry, non-sterile cotton tip is an example.

Can all class I devices be exempted? Probably not. But ones that apply the same design for over 30 years, and are still common (ie didn't cause a lot of trouble and weren't yet replaced by something much better) - in other words, are "well-established" and "low risk", probably can. And in many cases there will also be well-established published standards to cover such devices anyway, so it all fits together nicely.

Does that eliminate grey area completely? Probably not, but that's the business. I think it's still quite workable.
Again, I agree.

And as always, I think we are talking most the same thing, but maybe my point is not clear.

I do not disagree that the exception can be applied to low risk,well established devices (even if we do not have a definition and have to use common sense).

My problem is, does it applied "only" to low risk, well established devices? If not, how can I justify not using clinical data? And that's when i tried to rationalize the benefit part. And as I mentioned above, a lot of manufacturers do not have clinical data. Do they need it, meaning, do they need to begin doing clinical investigations? This is what is not clear in either the regulation or the MEDEV.
 
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Ronen E

Problem Solver
Staff member
Moderator
#26
My problem is, do it applied "only" to low risk, well established devices?
In my opinion, yes. It makes decision making easier, although it disappoints some manufacturers.

If not, how can I justify not using clinical data?
For discussion's sake - by showing that the device's nature & design are such that there's no reasonable doubt about it's safety (including unacceptable side effects) and performance, that would need proof from an actual clinical setting. I realise that this probably narrows down the applicability to simple, low-risk devices, but I think that this was the actual intent. If the device works in a complicated, harder-to-predict way, how can you show that it's safe and effective other than through actual, statistically valid use?

a lot of manufacturers do not have clinical data. Do they need it, meaning, do they need to begin doing clinical investigations?
I don't argue for everyone starting to run clinical investigations like mad, just for uniformity sake.

I do, however, argue that yes, most manufacturers need to have clinical evidence on file. I also think most of them actually have it, but many are too lazy to collate it and analyse it properly, or are trying to save the costs of a properly done literature search and analysis. If a device is not novel or has been around for long, there must be some sort of cumulative evidence for its safety and performance.
 

Roland chung

Trusted Information Resource
#27
I tend to agree with Ronen. But again, how to interpret the "Where demonstration of conformity based on clinical data is not deemed appropriate"? After the long discussion, it seems to be depended on the common sense.
 

Marcelo

Inactive Registered Visitor
#28
For discussion's sake - by showing that the device's nature & design are such that there's no reasonable doubt about it's safety (including unacceptable side effects) and performance, that would need proof from an actual clinical setting. I realise that this probably narrows down the applicability to simple, low-risk devices, but I think that this was the actual intent. If the device works in a complicated, harder-to-predict way, how can you show that it's safe and effective other than through actual, statistically valid use?
Yeap, but then again we go back to begin requiring clinical investigations for a lot of devices that are in the market today. And you are right, the intent seems to be this, but what I'm arguing is that applying the intent for all devices (in particular when using the new MEDDEV) may seem a bit unfeasible, for several reasons.

I do, however, argue that yes, most manufacturers need to have clinical evidence on file. I also think most of them actually have it, but many are too lazy to collate it and analyse it properly, or are trying to save the costs of a properly done literature search and analysis. If a device is not novel or has been around for long, there must be some sort of cumulative evidence for its safety and performance.
My experience is different. Most actually do not have it (and it's worse with the MEDDEV makes it more difficult to use "equivalent" devices, which was the justification in the past) and this include all types of manufacturers I work with. And they are not trying to save on the cost. But anyway, maybe it's only I that am experiencing this.

If a device is not novel or has been around for long, there must be some sort of cumulative evidence for its safety and performance.
Sure, but not in "clinical data" as defined. They may have a lot of other data, for example, low count of adverse events, etc. But this is not clinical data. So if we say that these devices, which may not be low risk, simple devices, need clinical data, these other justifications do not count, we do need clinical data and, due to the lack of data, we need a clinical investigation.
 

Roland chung

Trusted Information Resource
#30
Sure, but not in "clinical data" as defined. They may have a lot of other data, for example, low count of adverse events, etc. But this is not clinical data. So if we say that these devices, which may not be low risk, simple devices, need clinical data, these other justifications do not count, we do need clinical data and, due to the lack of data, we need a clinical investigation.
I do not know why you mentioned the clinical investigation again and again. This is not the intent of regulations. It is not true that there are no literatures for many products.
It is important to recognise that there is considerable diversity in the types and history of technologies used in medical devices and the risks posed by them. Many devices are developed or modified by increments, so they are not completely novel. It may be possible to draw on the clinical experience and literature reports of the safety and performance of an equivalent device to establish the clinical evidence, thereby reducing the need for clinical data generated through clinical investigation of the device under evaluation.​
 
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