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Change on Medical Device Classifications - Dental Crowns

Pjservan

Involved In Discussions
#1
We have been working with a Dental supply company that manufactures dental crowns. Currently the crowns are considered Class 1 Medical devices. In the last few weeks we have heard from numerous sources that this classification will change in 2020. Can anyone direct me to an official source where this type of discussion is being held or upcoming approved changes/ changes being considered? Thanks!
 
#2
Annex VIII, Section 5.4 of the new MDR regulations says:
"Rule 8
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
— are intended to be placed in the teeth, in which case they are classified as class IIa;


Tooth crowns are implants and from that I read it seems they are classified as class IIa. However, what I find strange about this is that the current law (the MDD) has the same definition and classification rule. I honestly don't understand how your tooth crowns are class I devices.
Perhaps someone else can shed light on this matter.

Shimon
 

Mikilk

Involved In Discussions
#3
Dental Crowns have been classified as Class IIa in the MDD as well...it was never been Class I device.
 
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