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

Ronen E

Problem Solver
Staff member
Moderator
#61
Well, that seems to me to be totally different from what the current MEDDEV guidance expects.
This is part of the problem. I do think that rev. 4 went too far, and many in the industry think the same. Maybe even you.

I think that MEDDEV documents' role is not to replace the regulation or adjust it / keep it up to date. Their role is to clarify the regulation, and interpret it in line with their original authors' intents. In that sense I'm not sure rev. 4 is not a mistake. How does it accommodate the clause that started this thread? Maybe it never intended to, because it deals with Clinical Evaluation, and that clause completely bypasses the clinical evaluation path.

Keeping the regulations up to progress should be done through a proper legislative process, as has been done in issuing the MDR (whether a good job was done or not is a different question). The updated regulation - the MDR - will take effect in less than 3 years, and until that time the older regulation - the MDD, as amended in 2007 - should be the prevailing standard (upgrade in anticipation of the change may be recommended, but not yet mandated). If anyone thought that the MDD doesn't provide sufficient assurance, they should have pushed for another MDD amendment while the MDR was in the making (a very long time!). I know that it wasn't done in the name of efficiency and preserving resources, but it shouldn't have been used as a justification for hijacking regulatory power (as 2.7/1 in fact did, whether its authors meant it or not).

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.
This is less relevant to the OP. The clause of interest doesn't talk about how to avoid clinical investigation while preparing a clinical evaluation; it talks about situations where a clinical evaluation is not necessary to begin with.
 
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Marcelo

Inactive Registered Visitor
#62
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.
You previously mentioned that the standard was wrong/old/whatever and that no regulation currently requires that.

I was just pointing out that the standard is new and in line with current expectations (and obviously no regulation would directly require clinical evaluation for one type of device, but the FDA guidance, although a guidance, does express the agency current view on the subject).

This is part of the problem. I do think that rev. 4 went too far, and many in the industry think the same. Maybe even you.
In some ways, yes.

I think that MEDDEV documents' role is not to replace the regulation or adjust it / keep it up to date. Their role is to clarify the regulation, and interpret it in line with their original authors' intents. In that sense I'm not sure rev. 4 is not a mistake. How does it accommodate the clause that started this thread? Maybe it never intended to, because it deals with Clinical Evaluation, and that clause completely bypasses the clinical evaluation path.

Keeping the regulations up to progress should be done through a proper legislative process, as has been done in issuing the MDR (whether a good job was done or not is a different question). The updated regulation - the MDR - will take effect in less than 3 years, and until that time the older regulation - the MDD, as amended in 2007 - should be the prevailing standard (upgrade in anticipation of the change may be recommended, but not yet mandated). If anyone thought that the MDD doesn't provide sufficient assurance, they should have pushed for another MDD amendment while the MDR was in the making (a very long time!). I know that it wasn't done in the name of efficiency and preserving resources, but it shouldn't have been used as a justification for hijacking regulatory power (as 2.7/1 in fact did, whether its authors meant it or not).
The only problem is that the MEDDEV approach can clearly be seen in the new regulation, so I would not say that is was a mistake. My opinion (as I've been doing several clinical evaluations to be in line both with the MEDDEV and with the new regulation) is that the MEDDEV was revised to be a bridge between the current, too generic MDD requirements, and the more specific requirements of the new regulation. That's why, between other factors, I'm pretty sure it was planned that way.

Quote:
; it talks about situations where a clinical evaluation is not necessary to begin with.
A clinical evaluation is always required, however, performing a clinical evaluation using clinical data or not is what the OP was referring to.
 

Ronen E

Problem Solver
Staff member
Moderator
#63
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.
The device is home blood pressure monitor which is absolutely a well-established and low risk device.
This is not specific enough.

Before you try to provide more details, please let me say that I think it's pointless. We can probably never get specific enough at a public forum discussion level. To be able to provide useful advice regarding the applicability of a given MDD clause to a given device, one would need to know the device's technical details (how exactly it works and what are it's outputs and limitations, etc.), it's intended use in detail, its contraindications and warnings etc.
 

Ronen E

Problem Solver
Staff member
Moderator
#64
You previously mentioned that the standard was wrong/old/whatever and that no regulation currently requires that.

I was just pointing out that the standard is new and in line with current expectations (and obviously no regulation would directly require clinical evaluation for one type of device, but the FDA guidance, although a guidance, does express the agency current view on the subject).
I didn't say that the standard was old. I said that unless it's old, it has a flaw (in my opinion). What I meant regarding the regulations is that no modern/leading regulatory system that I know demands clinical investigation in each and every instance except for high-risk devices. So I don't see why a standard dealing with a low/moderate risk device type should be that prescriptive. Again, the FDA's general approach doesn't mandate presenting clinical data for medium-risk devices. That general approach also doesn't mandate applying published standards (even recognised ones) or FDA's guidance documents, where regulatory compliance is demonstrated otherwise. So as an example for a regulatory system that is that prescriptive, it's not a very good one.

The only problem is that the MEDDEV approach can clearly be seen in the new regulation, so I would not say that is was a mistake.
I would say otherwise - that the mistake has been duplicated (or carved in stone). At least in the MDR's case it has been done through a proper legal process. As part of that, manufacturers have been provided with a proper transition period, so that they could upgrade their CERs if necessary; unlike the MEDDEV revision, which has been made "effective as of publication".

My opinion (as I've been doing several clinical evaluations to be in line both with the MEDDEV and with the new regulation) is that the MEDDEV was revised to be a bridge between the current, too generic MDD requirements, and the more specific requirements of the new regulation. That's why, between other factors, I'm pretty sure it was planned that way.
While I think I understand your thinking, I think that that approach is a little unfair towards manufacturers. The MDR is not yet in effect, and will not be for a while longer. Meanwhile, the effective regulation is the MDD, and it (including, as much as possible, the intents behind it) should be respected. Using the MEDDEV route (with its "convenient" immediate taking effect) to force premature application of such a big shift is WRONG.

It's wrong to say "It's OK to make a MEDDEV effective-as-of-publication, because it's just a guidance" and at the same time to apply MEDDEV as if it was duly issued regulation.

A clinical evaluation is always required, however, performing a clinical evaluation using clinical data or not is what the OP was referring to.
Sorry, this is what I was referring to, too. Should have worded more carefully.
 

Roland chung

Trusted Information Resource
#65
In the end, there is still no a conclusion.

My instinct is that the exception should be suitable for a few products only. "Not appropriate" should mean no clinical data are available for specific device, but not due to novel technology.
 

Ronen E

Problem Solver
Staff member
Moderator
#66
In the end, there is still no a conclusion.

My instinct is that the exception should be suitable for a few products only. "Not appropriate" should mean no clinical data are available for specific device, but not due to novel technology.
Not sure how you reached those conclusions.

the only way I currently conceive being able to help you in this specific instance is through a confidential business engagement. Please feel welcome to PM me if interested, though you might be better off just preparing a conventional CER, either yourself or with the aid of a specialist.

Sorry.
 

Remus

Involved In Discussions
#68
Actually, EC wants clinical investigations from all devices. Also, they intend to accept only %100 same devices as equvalent... (also you have to provide evidence for each clam...) So, most clinival data isn't useable for most devices.

In practice you cant write CER report without a clinical investigation.

Most NB's are give up anyway. TUV Sud postphoned Meddev 2.7.1 rev4 to 2020...
 
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