Hi everyone.
Sorry for not participating much as of late - getting used to a new job and all.
Anyway - at my new gig we make labels, inserts, outserts, booklets and flexible packaging for regulated industries - mostly pharma, some device, a very small amount of personal care.
What I'm curious about is how packaging is covered in the MDD. We mostly do secondary packaging but some of our flexible packaging can be used as primary. If we have a EU customer interested in, for example, a peel off heat seal lid that will directly contact a device inside a tray - what might we be responsible for beyond GMP's?
How about booklets or outserts in multiple languages?
Any feed back is appreciated.
Sorry for not participating much as of late - getting used to a new job and all.
Anyway - at my new gig we make labels, inserts, outserts, booklets and flexible packaging for regulated industries - mostly pharma, some device, a very small amount of personal care.
What I'm curious about is how packaging is covered in the MDD. We mostly do secondary packaging but some of our flexible packaging can be used as primary. If we have a EU customer interested in, for example, a peel off heat seal lid that will directly contact a device inside a tray - what might we be responsible for beyond GMP's?
How about booklets or outserts in multiple languages?
Any feed back is appreciated.