Special conditions for Class III custom made implantable in contact with the CNS

[kreid]

Hello,
I was asked whether there were any special conditions for EU market access for a Class III custom made implantable in contact with the CNS.
Looking at Art 52 & 54 & Annex XIII plus MDCG 2021-3, I can see that a conformity assessment procedure covering QMS certification by a notified body is applicable to Class III implantable CMDs.
Are there any other special measures?
I was asked by a company that has previously been told (I think by a consultant, not the NB) that they cannot market such a device, but it was not explained why. They presume that they are missing a step/process or something else.
They have at ISO13485 cert from their NB, and I think this satisfies the above?
Thanks
K

 

[Raisin picker]

Did you use the search function here? A similar question was asked and answered just last week, in the same subforum., by someone named kreid.

Afaik, contact to CNS affects classification, but nothing else.

 

[kreid]

Did you use the search function here? A similar question was asked and answered just last week, in the same subforum., by someone named kreid.

Afaik, contact to CNS affects classification, but nothing else.

It was a similar question, but this is specifically about Class III as I know there were additional requirements for Class III implantables introduced such as the additional review of clinical investigations by the NB and then the submission of a NB report to a panel of experts provided by EC.
I think the above is not required for Custom devices, but am not sure. I also wonder if I have missed any similar additional requirement for the device type I mentioned, i.e. Class III custom made implantables in contact with the CNS. As I say the company were told that they were not able to market their device based on the that they have carried out for their Class IIb devices, also custom implantables.
Thanks
Kreid