MDCG 2020-3 notes: If a change is not a significant change in design or intended purpose under MDR Article 120(3), the implementation of such a change is therefore allowed during the transitional period. Acc. to section 3 the certificate should not be amended.
According to this sentence, non-significant change is only allowed before DOA(2021/5/26).
Can MDD complaint device make significant change after DOA and prior to 2024/5/26 ?
According to this sentence, non-significant change is only allowed before DOA(2021/5/26).
Can MDD complaint device make significant change after DOA and prior to 2024/5/26 ?