Hi everyone,
We manufacture class III invasive & implantable device according to the MDR definition, we have MDD CE certifications and now transitioning to MDR.
The clinical evaluation we submitted to the MDD NB was based on literature review of similar/equivalent device,
Is it possible for us to use the same old approach (use of similar/equivalent device's clinical data) to support conformity with the MDR?
I'm wondering if the old clinical evaluation would still be appropriate for the MDR submission, the content of the old report does not qualified for the definition of "clinical data" anymore and it is meaningless right? For we do not have a contract in place to claim equivalence.
Would this leave us the only option of conducting a clinical investigation?
Any advice is kindly appreciated !~
We manufacture class III invasive & implantable device according to the MDR definition, we have MDD CE certifications and now transitioning to MDR.
The clinical evaluation we submitted to the MDD NB was based on literature review of similar/equivalent device,
Is it possible for us to use the same old approach (use of similar/equivalent device's clinical data) to support conformity with the MDR?
I'm wondering if the old clinical evaluation would still be appropriate for the MDR submission, the content of the old report does not qualified for the definition of "clinical data" anymore and it is meaningless right? For we do not have a contract in place to claim equivalence.
Would this leave us the only option of conducting a clinical investigation?
Any advice is kindly appreciated !~
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