GMDN (Global Medical Device Nomenclature) Codes

Marcelo Antunes said:

There?s a lot of regulatory requirements that does not help at all the manufacturers. But it will usually be justified by the regulators that set the requirements - in this case, basic traceability and easy recognition and general labeling of several thousand types of different medical devices.

In those cases, for the manufacturer, the only real justification is: because the regulator said so (even if it?s not value-added from the standpoint of the manufacturer).

So, as I said before, it?s still the case of the cost of doing business, even if you think you are not getting much in return.

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I question if there's really any value-added at all (not just from a manufacturer's standpoint), and that's what irks me.

GMDN, like your post, will speak of "traceability" and identification, but I'm hard pressed to think of cases where a GMDN code actually helps. Do you have an example?

Several reasons I think the "value" of these codes is questionable:

1. You need a GMDN membership to lookup any codes, so the utility is already very limited.
2. There is no requirement to have the code anywhere on the labelling of the actual device, so the link between device and code are going to be limited to a database somewhere.
3. If someone were to lookup the code, they'd only find a less-detailed description of what is already written on the device labelling and packaging.

I question if there's really any value-added at all (not just from a manufacturer's standpoint), and that's what irks me.

GMDN, like your post, will speak of "traceability" and identification, but I'm hard pressed to think of cases where a GMDN code actually helps. Do you have an example?

Several reasons I think the "value" of these codes is questionable:
You need a GMDN membership to lookup any codes, so the utility is already very limited.
There is no requirement to have the code anywhere on the labelling of the actual device, so the link between device and code are going to be limited to a database somewhere.
If someone were to lookup the code, they'd only find a less-detailed description of what is already written on the device labelling and packaging.

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Let me correct my last post then - I said things about traceability and identification, but this is really not why in principle codes are needed.

They are needed as a generic framework for regulations in general. In the past, different jurisdictions had different sets of codes for high level classification of medical devices. When regulators tried to talk to each other about a device, they had problems in understating what they were talking about. So, there was a need to have a set of defined classification for identification of devices in the global market.

That?s in fact the main reason, and main value, of the GMDN codes. The problem is, it is a framework, structuring value, so it?s really difficult to point a practical value for manufacturers. The value would be seen if the structure did not exist - you would have a lot of practical problems if you sold your devices in several countries (and as I mentioned, these problems did happen in the past a lot).

The Background introduction to the document "(broken link removed) is a good companion to what I?ve just said.

The problem is not the structure or the function. These are understandable.

The problem is the funding model. If regulators around the world concluded that this is such a valuable tool, they should have budgeted to fund it. Where these funds would have come from? Correct, from regulators' existing funding sources, which include fees paid by manufacturers. That would be a more fair and sensible arrangement, IMO.

The current situation is like an individual flying in a commercial international flight and having to pay a fee every time the aircraft enters the airspace of a country. After all, there are costs associated with managing and controlling air traffic above a country, and everyone would agree that these systems / functions are beneficial to the individual passenger, right? Nevertheless, we don't have to do that. We pay a fixed price when we purchase the flight ticket, and these funds trickle to wherever they are utilised, through the airline and so on, perhaps even ending up indirectly contributing to air traffic control system operation. We don't pay a separate fee for every single bit in the package, regardless of how essential it is.

Cheers,
Ronen.

They are needed as a generic framework for regulations in general. ...The value would be seen if the structure did not exist - you would have a lot of practical problems if you sold your devices in several countries (and as I mentioned, these problems did happen in the past a lot).

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I'm still dubious as to it's utility, even as a "generic framework for regulations". How is it a framework for regulations? As far as I know, there is no strict link between GMDN codes and, say, regional device classification (which does actually affect regulations).

I'd imagine that, in practice, the following take precedence over GMDN terms when it comes to regulatory matters:
1. The regional device classification
2. The licensed/registered/approved trade name & license/DoC/510k etc.
3. The manufacturer's intended use and indications for use

With all of the above in play, I don't see the value of descriptor codes for regulatory purposes. Even for communication between international agencies: because the GMDN are only generically descriptive, and are non-prescriptive when it comes to regulatory affairs, different countries will still have to handle devices on a case-by-case basis.

As far as having a "common" international language for describing generic macro categories, I think that terms like active, implantable, measuring, sterile, IVD, and associated clinical application (general, radiology, neurology...) work great!

jkonholm said:

i hope you like it..! (Attached)

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Thank you so much!