Dear all,
we are in need of revising an existing DoC for a legacy IVD medical device because the company address has changed due to a office move. Following MDCG-2022-6 this isn't a significant change so is permitted even for device after the 26th of May 2022.
I am now a bit stumped how to revise the Doc given the following sentence of the IVDR 110 (3):
Usually when creating a DoC I would have put the date of it being signed, but this date would be after 26th of May 2022. Should I create an amendment that mentions the new address, but leave the old "wrong" DoC intact?
I don't want to get into the situation that we lose the ability to put the legacy device on the market, while we transition to IVDR.
we are in need of revising an existing DoC for a legacy IVD medical device because the company address has changed due to a office move. Following MDCG-2022-6 this isn't a significant change so is permitted even for device after the 26th of May 2022.
I am now a bit stumped how to revise the Doc given the following sentence of the IVDR 110 (3):
Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive
Usually when creating a DoC I would have put the date of it being signed, but this date would be after 26th of May 2022. Should I create an amendment that mentions the new address, but leave the old "wrong" DoC intact?
I don't want to get into the situation that we lose the ability to put the legacy device on the market, while we transition to IVDR.