Question regarding classification of custom made device

[JayceRobb]

Hello,

I'm a manufacturer of CMD for dentistry, including crowns, bridges and full dental prosthesis, either implant or teeth supported. I've done some research and found that maybe all of these are classe IIa according to rule 8? I have a hard time understanding if the implant-supported products would be class IIb, as they are technically not placed in the teeth, and dental implants and abutments are IIb. Is this related only to the screw and connector itself?

Also, how many different technical dossiers do I need to have for these products? The intended purpose seems to be the same for all the products.

Thank you

 

[KShaw]

Hi JayceRobb,

Rule 8 is the "go to" rule for implantable devices and long-term surgically invasive devices (keeping in mind the definition of an implantable device in Article 2(5)).

When placed in the teeth, the product will take on a Class IIa classification. However, if your products include devices which are being fixed into the patient and are surgically invasive but not considered to be "placed in the teeth", then they will be Class IIb through Rule 8.

In the other case where your product is being fixed to an existing implant, as long as it is not surgically invasive, you can take an approach through Rule 5 to classify these as Class IIa (long-term invasive).

With respect to technical documentation, it would be preferable to have these separated out per product group. With that said, you could have one technical file taking into account the different products. E.g. you will have 1 Device Description and Specification document but within it, you must provide a separate description for all your products. So there's still a similar amount of work to be done.

We would also usually suggest that a Declaration of Conformity (in your case, if these are CMDs, an Annex XIII statement) be drafted for different product groups.

Hope this helps!

 

[JayceRobb]

Thank you so much Kshaw! Your answers regarding the classification are very clear and helpful.

Regarding the technical documentation, I'm starting to realize the amount of work needed would be similar regardless of the approach. Since I have multiple materials for each of the products, I'm guessing it would make more sense to group the devices. In this case, would it make sense to group by classification rule or type of product? For example, all crowns as a group, all full dental prosthesis as another, or would it be better to group crown/bridges placed on the teeth vs crown/prostheses/bridges placed on implants?

 

[JayceRobb]

I've been looking at the rules and getting very confused: Can I take the Rule 8 approach for devices places in the teeth and Rule 5 for the other devices placed in the implants, taking into account that both would technically be implantable devices per the definition? It doesn't make much sense to classify them as class IIb just because they are placed over implants and are not surgically invasive, but both need a dentist to put them in place.

 

[KShaw]

I've been looking at the rules and getting very confused: Can I take the Rule 8 approach for devices places in the teeth and Rule 5 for the other devices placed in the implants, taking into account that both would technically be implantable devices per the definition? It doesn't make much sense to classify them as class IIb just because they are placed over implants and are not surgically invasive, but both need a dentist to put them in place.

I don't blame you for getting confused, it's not that clear cut.

Based on the information you've given, our interpretation would be that the devices placed in/on the implants (the implant supported devices) are not considered implantable devices as they do not seem to meet the definition in Article 2(5):

‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye,
by clinical intervention and which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;

Since your devices are not being introduced by a clinical intervention (only the supporting implant is), you can justify that your devices are not an implant. On the other hand, those devices which are being introduced into the teeth can be considered to be done so by clinical intervention, and so these would be considered an implantable device by the definition above.

As such, Rule 5 (third bullet point) would lead you to a Class IIa classification for those implant-supported devices.

All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:
— class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.

 

[KShaw]

Thank you so much Kshaw! Your answers regarding the classification are very clear and helpful.

Regarding the technical documentation, I'm starting to realize the amount of work needed would be similar regardless of the approach. Since I have multiple materials for each of the products, I'm guessing it would make more sense to group the devices. In this case, would it make sense to group by classification rule or type of product? For example, all crowns as a group, all full dental prosthesis as another, or would it be better to group crown/bridges placed on the teeth vs crown/prostheses/bridges placed on implants?

You're most welcome

It's usually best to group by intended purpose. However, since they may have similar intended purposes but a different classification, it would be best to have these split up. At the end of the day you will need to do your best to present the information in such a way that the Notified Body finds it easy to navigate (believe me, it will save you a lot of time and money!).