JoCam
Trusted Information Resource
Hi All,
For a class IIa medical device that consists of numerous sub-assemblies, all of which carry individual UDI 's, should the final assembly also be labelled with a UDI?
This does sound like a stupid question, but in effect would result in the outer cover of the product (which is a sub-assembly) carrying 2 labels.
Jo
For a class IIa medical device that consists of numerous sub-assemblies, all of which carry individual UDI 's, should the final assembly also be labelled with a UDI?
This does sound like a stupid question, but in effect would result in the outer cover of the product (which is a sub-assembly) carrying 2 labels.
Jo