Same Medical Device, Different Classifications By Different NB?

[rcjpedro]

Hi All!

What say you when the same Medical Device gets classified as IIb by a NB and as IIa by a different NB? I have the certificates, one my own and competition downloaded from the world wide web.

And to whom should this issue be reported?

Thanks in advance!

 

[Mark Meer]

I don't know how this is possible.

I didn't think that it was allowed to have more than one NB for a given device...

In anycase, is it not possible to ask for the classification rationale? i.e. by what MDD rule is the device classified?

 

[rcjpedro]

Hi Mark

Sorry for any confusion.

One device is manufactured by my company and certified by one Notified Body, class IIa

The other device is placed on the market by another manufacturer(competition), certified by a diferent Notified Body, class IIb.

Thank you for your interest

 

[Mark Meer]

In my experience, it's up to you to present the classification and rationale (MDD rule) for your device, and NBs will review and either agree or not.

...so if your NB agrees with your rationale for Class IIa, then great!

The fact that a competing (equivalent) device has a different classification through a different NB probably just means that the other manufacturer or NB has adopted a different interpretation of the rules with respect to their device.

Because (I presume) you and your competitor's devices are not completely identical, this may be a result of, for example, different materials, differently worded intended use/indications, or perhaps simply a more conservative definition of "potentially hazardous" when assessing the MDD rules.

 

[rcjpedro]

Hi Mark

Upon first submission of TF for approval we had a CAPA request based on a NB Consensus Statement regarding this type of equipment

In Consensus Statement it was clear that they are IIa

Off topic a bit but how can Global Medical Device Nomenclature (GMDN) work if this kind of situation is not addressed?

Thanks in advance

 

[Mark Meer]

Off topic a bit but how can Global Medical Device Nomenclature (GMDN) work if this kind of situation is not addressed?

I don't know. This is a shortcoming of such systems.

I'm not a big fan of attempts for descriptive categories like GMDN, or the FDA's product codes. They are just too rigid, and fail to account for all the possible variations in the way a device can be designed, constructed, and operated.

I think a risk-based rule system (like in MDD 93/42/EEC Annex IX) is preferable, as it allows devices to be assessed case-by-case.

 

[pkost]

the above points are correct - the manufacturer evaluates the rules and decides a classification which they must justify. The NB then reviews this classification, if they agree then all is good.

The decisions of the NBs should be aligned however they aren't always. If you do not agree with your NB's decision, then you can request clarification from the competent authority. If you still disagree then the European court has final say in the matter (I've missed some steps).

Likely causes of a difference:

1. There is an additional claim in one product that changes the classification, it could be subtle and easy to miss. (If the two NBs you refer to are in the same country I would say this is the more likely option)

2. There are some products that competent authorities classify differently​

 

[chris1price]

If the two devices are correctly classified, that it is likely that the intended use of the devices is different. This could be the location in the body the device is used, whether it is is intended to be connected to an active device, etc.

I dont think there is currently a connection between the GMDN code and the classification unde rthe MDD, although this may chnage in the future.