ragasudhav
Registered
Can someone please help me on this? For active implantable devices where there are double sterile barriers, is it fine to put labels on secondary barrier instead of primary, since the device goes to the OT room with the secondary barrier and traceability is maintained.
In MDR, its quoted as ""Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI)".
Does this mean, the label should appear on the primary sterile barrier?
Thanks.
In MDR, its quoted as ""Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI)".
Does this mean, the label should appear on the primary sterile barrier?
Thanks.