D
danush
Hello all!
My company developed a class III implant and we are now in the process of conformity assessment. One of the reviewers of the technical file raise the follwoing issue related to DoC:
According to the general interpretation by authorities, the declaration of conformity has to be limited to a series of specific devices (SN / LOT) manufactured or limited validity (expiry date) of the declaration should be indicated.
It seems that he requires us to specify all LOTs that we plan to manufacture or limit the DoC itself in time, which is not in line with MDD requiremenst, as far as I understand.
Can anyone clarify?
Thanks.
My company developed a class III implant and we are now in the process of conformity assessment. One of the reviewers of the technical file raise the follwoing issue related to DoC:
According to the general interpretation by authorities, the declaration of conformity has to be limited to a series of specific devices (SN / LOT) manufactured or limited validity (expiry date) of the declaration should be indicated.
It seems that he requires us to specify all LOTs that we plan to manufacture or limit the DoC itself in time, which is not in line with MDD requiremenst, as far as I understand.
Can anyone clarify?
Thanks.