Is a Removable Partial Denture classified as Class I Medical Device?

[tehuff]

Hi - looking for clarification of device classification for a Removable Partial Denture. It is worn for years, but taken out for cleaning, at night, etc.
I am looking at Rule 5 which lists Materials for manufacturing dentures as Class I but not sure this is the correct interpretation. Are "materials for manufacturing dentures" classed differently than "dentures"?
Long term use, in the oral cavity as far as the pharynx, falls in Class IIa per this same rule (Rule 5).

Is the wearing time cumulative over the life of the device? Is a removable denture considered a short or long-term (>30 days) use?

Thanks!

 

[chris1price]

Re: Is the Removable Partial Denture classified as Class I device?

Hi, thats a difficult question! My initial reaction was that they should be IIa. I believe "Materials for manufacturing dentures" refers to materials for making impressions, which would be short term, so class 1. The EU Guidance on classification talks about immediatley replacing a device with the same type of device as extending the use to continuous. so I would say, removing the denture, cleaning and relacing it does not interupt its use; making the denture long term, so Class IIa.

However..... there is an NIST guidance document for MDD Classification that places removalbe dentures as class 1. http://gsi.nist.gov/global/docs/EUGuide_MedicalDvceDirective.pdf

The GHTF guidance also places removable dentures as class A, although that is a very slightly different system.

A last resort is to see what your competitors do. If their labelling contains a Notified Body number, then its IIa, if they just have a plain CE Mark, the device is class I.

As is so often the case with the MDD, talk to your Notified Body about it. The NIST guidance may be convincing to a US NB. Ultimately they are the ones that will make the decision.

 

[pkost]

Re: Is the Removable Partial Denture classified as Class I device?

I would say that EU considers this to be Class I on the basis that the dentures are cleaned daily in an overnight process. Although they are used for many years, continuous use is defined as:

In calculating the duration referred to in Section 1.1 of Chapter I,
continuous use means ‘an uninterrupted actual use of the device for the
intended purpose’. However where usage of a device is discontinued in
order for the device to be replaced immediately by the same or an identical
device this shall be considered an extension of the continuous use of the
device.

You can argue that if the denture is being washed/cleaned it is not immediately replaced, therefore rule5 short term (<30 days continuous use) applies

 

[pdzip2]

Re: Is the Removable Partial Denture classified as Class I device?

Do we know for sure that people don't sleep with their dentures in their mouth? That would make a case for continuous use.


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[pkost]

Re: Is the Removable Partial Denture classified as Class I device?

This wouldn't impact continuous use because classification is driven by the use intended by the manufacturer, not the misuse by an end user


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[Chrisx]

Re: Is the Removable Partial Denture classified as Class I device?

I thought these were generally custom devices, as they are designed to fit a specific patient. As such, they are excluded from conformity assessment.

 

[pkost]

Re: Is the Removable Partial Denture classified as Class I device?

I'd missed this minor detail!