Is UDI required on the Packaging of a Serviced/Repaired Medical Device?
- Thread starter shimonv
- Start date
Per this: 7 Things You Need to Know about US UDI Compliance
the UDI needs to be on packaging up to the point of the shipping carton.
I would think this applies to both new and repaired devices.
the UDI needs to be on packaging up to the point of the shipping carton.
I would think this applies to both new and repaired devices.
shimonv
Trusted Information Resource
Thanks ScottK,
One of the UDI attributes is manufacturing date. In my mind there is a clear distinction between manufacturing and repair dates.
I cannot see any use in implementing UDI on serviced items. Unfortunately the regulation is not clear about it (it is not explicitly exempted), so I have to assume that it is required.
Shimon
One of the UDI attributes is manufacturing date. In my mind there is a clear distinction between manufacturing and repair dates.
I cannot see any use in implementing UDI on serviced items. Unfortunately the regulation is not clear about it (it is not explicitly exempted), so I have to assume that it is required.
Shimon
I don't think you change the UDI after a repair.... you can mark it in some way to indicate a repair has been done, but the UDI is always the UDI from the date of manufacture.
But I haven't done UDI work in a while... so I'd like to see what others say.
Hey Shimon! Did you ever get an answer for this? In our case, we upgrade some medical devices in the field. Basically, a customer can request an upgrade from 15.0 to 16.0. What we currently do is that we update the DI but then use the same PI as the original machine, which it is a pain. My question would be if it would be okay to change the PI.
Thanks!
Thanks!
Edgar Trejo
Registered
Hello, did you ever find an answer to this question? My company is facing the same situation.