Intervertebral body fusion cage, MDR Class II or Class III?

JoselVLC

Starting to get Involved
#1
We would appreciate if you could give us some clues to know if an intervertebral body fusion cage is classified as Class II or Class III under MDR. Thank you.
 
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Raisin picker

Involved In Discussions
#2
MDR states (Annex VIII):
5.4. Rule 8
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
— [...]
— are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;
— [...]
— are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.
AFAIK, fusion cages are not designed for contact with the spinal column, hence class IIb. But you will know if your cages have an intended use that allows for said contact and then they would be class III.
 

JoselVLC

Starting to get Involved
#3
MDR states (Annex VIII):


AFAIK, fusion cages are not designed for contact with the spinal column, hence class IIb. But you will know if your cages have an intended use that allows for said contact and then they would be class III.
I know that the key point is the contact with the spinal column as you said. But if so, what is considered as the spine?, vertebral bodies?, spinous processes? Or just the spinal cord?
Thanks.
 

Raisin picker

Involved In Discussions
#4
It's the spinal cord itself. That piece of matter that is considered part of the central nervous system ;-)
As I said, the intervertebral body fusion cages I know are considered as class IIb (MDD, but the definition is the same under MDR). If your cages are not special in some way, they are IIb as well.
 

Chrisx

Involved In Discussions
#5
I had not heard of this definition of spinal column. The MDR has no defintion. In general, I have always interpreted the term "wedge" in the regulation to be a reference to intervertebral bodies. As such, they would be class IIb. I believe there is an NB-Med guidance that tries to add some clarity to this.
 
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