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

Marcelo

Inactive Registered Visitor
#31
I do not know why you mentioned the clinical investigation again and again. This is not the intent of regulations.
It's not the intent of the regulations, but that's what happens in the end in practice. Manufacturers do not have clinical performance and performance data (even if they have an equivalent device which is worse to use solution now due to the new MEDDEV), so the conclusion is that they not have enough data. The only way to gather new data is thru clinical investigations.

Again, this is my experience with performing clinical evaluations according to MEDDEV 4 for my clients.
 
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Marcelo

Inactive Registered Visitor
#32
Maybe an example would work better than discussing concepts.

One client of mine has a two parameter monitor, let's say, pulse oximetry and ECG (class II). In the past, he wrote a clinical evaluation that found some papers related to what the considered equivalent devices - one device which had only pulse oximetry, and another device which was an ECG. He found some two or three papers the showed the clinical performance and safety of these devices was ok. He did not have any information on the clinical use of his device, because no one had required him to collect information on clinical use (he obviously had some information, but generally tossed together in a way that could not be used properly and not statistically valid, etc). So he created a a CER and used the "equivalent" devices as justification. He thought that would be all he needed to do.

Then came his re-evaluation, after the new MEDDED has been published. Suddenly, the devices he used as "equivalent" could not be used as "equivalent" anymore. He also did not have any more clinical data than he had in the past, because he thought what he did was enough. The only conclusion possible in this case is that more clinical data is needed, and the only way to get that is thru a clinical investigation.
 

Marcelo

Inactive Registered Visitor
#34
Created the rationale for why it did not needed clinical data, including the question on "direct benefit", and justified that by being in conformity with all current applicable standards, by having all possible risks analyzed and controlled, but having a very low count of adverse events, and that the benefit the device give could not be directly measured by clinical data (and there's some more justification, but for this discussion's sake, I just gave some examples), then we did conclude that it was not deemed appropriate to verify conformity with the specific ERs with clinical data, and that all of the above was enough to shoe conformity with the related requirements (again, I'm simplifying here what we did).

Also, this situation I mentioned is very, very common.
 
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Ronen E

Problem Solver
Staff member
Moderator
#35
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.
Maybe this is the problem's source.

MEDDEV 2.7/1 rev. 4 defines Clinical Data as follows:

Clinical data: the safety and/or performance information that is generated from the clinical use of a device. Clinical data are sourced from:

- clinical investigation(s) of the device concerned; or

- clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.
Maybe "low count of adverse events" in itself is not clinical data, but it may form part of "unpublished reports on other clinical experience of the device in question", and this is just an example.
 

Ronen E

Problem Solver
Staff member
Moderator
#36
The only conclusion possible in this case is that more clinical data is needed, and the only way to get that is thru a clinical investigation.
It's funny you give pulse oximetry and ECG as an example, because these are today "well-established" and maybe also "low risk" technologies, with so many devices in that category on the market and practically mountains of clinical data to choose from. In such cases I think the difficulty is not finding enough clinical data, but actually sorting the best data from all that's available.

He did not have any information on the clinical use of his device, because no one had required him to collect information on clinical use
This sounds strange. Most regulatory systems require some sort of PMS data collection.

he obviously had some information, but generally tossed together in a way that could not be used properly and not statistically valid, etc
This is what I previously meant. Some data is almost always available, but it requires some effort / resources to arrange it in a usable manner.
 

Roland chung

Trusted Information Resource
#38
Ronen, I agree with you that there are many clinical data for well-established devices (as per my experience as well). So can we employ the exception to skip the clinical data approach? But it would be very strange to consider that the clinical data approach is not appropriate.

I am wondering if we are going in the wrong direction.
 

Ronen E

Problem Solver
Staff member
Moderator
#39
Ronen, I agree with you that there are many clinical data for well-established devices (as per my experience as well). So can we employ the exception to skip the clinical data approach? But it would be very strange to consider that the clinical data approach is not appropriate.

I am wondering if we are going in the wrong direction.
It's hard to say without knowing your device's specifics.
 
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