I'm writing/correcting our CER where we had a nonconformity raised for the demonstration of equivalence:
'The equivalence rationale presented for the XXXXXXXX was not clear that the materials of the construct were the same and the clinical impact of minor differences in design noted were not fully justified'
We have used as comparison widely available product sold by many other manufacturers, they are all manufactured to the same standards (dimensional etc) but other manufacturer will never disclose to me what process he is using to manufacture (for coating) and what exact type of materials.
So how can I justify any differences (if there are any) in materials and design?
Your comments are greatly appreciated!

'The equivalence rationale presented for the XXXXXXXX was not clear that the materials of the construct were the same and the clinical impact of minor differences in design noted were not fully justified'
We have used as comparison widely available product sold by many other manufacturers, they are all manufactured to the same standards (dimensional etc) but other manufacturer will never disclose to me what process he is using to manufacture (for coating) and what exact type of materials.
So how can I justify any differences (if there are any) in materials and design?
Your comments are greatly appreciated!
