Medical Device Directive, Conversion from class IIb to class III

I

ISO MAN

Hi everybody,
We are working in the field of manufacturing orthopedic implants. The joints have been reclassified from class IIb to class III. I am looking for some guidance of the changes that should be done to be able to modify the technical file of class IIb devices to comply with class III devices.

Thank you
 

chris1price

Trusted Information Resource
I don't think your Technical File needs to be different, but the design has to be assessed by your notified body who issue a Design Examination Certificate. Have a look through Annex 3, section 4 of the MDD.

I would talk to your notified body and ask what the require submitted.
 
R

Roland Cooke

I'm fairly sure there was some guidance developed by NB-MED or somesuch, check with your Notified Body.
 
I

ISO MAN

Thank you all for your replys, does any one have such developed guideline from the notified bodies.

Thanks
 
Top Bottom