Hello,
I am hoping to find out whether a well-designed clinical study conducted on retrospective data can qualify as a clinical investigation and needs to comply with the clinical investigation requirements of the MDR for adding new indications to a legacy device CE marked under the MDD.
Thank you in advance.
I am hoping to find out whether a well-designed clinical study conducted on retrospective data can qualify as a clinical investigation and needs to comply with the clinical investigation requirements of the MDR for adding new indications to a legacy device CE marked under the MDD.
Thank you in advance.
