MDD (Medical Device Directive) and Secondary Packaging

ScottK

Not out of the crisis
Leader
Super Moderator
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.
 

bio_subbu

Super Moderator
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.

Can you provide little more details about your product such like indented use, sterile or non-sterile?.
 
M

MIREGMGR

EN ISO 11607 is the relevant standard for MDD sterile-device packaging conformance. Part 5.1.6 (b) requires "evaluation" of the biocompatibility of materials. The accompanying note qualifies the requirement to be "usually" restricted to material in contact with the device. That's vaguely written, but it's possible to determine a rigorous and thus conservative conformance approach.

Thus your customer should expect you to supply biocompatibility data for their Tech File.

Language requirements for labels and IFUs are clear. Include the official language of each EU country into which the product will be distributed. Maximize the use of international-standardized symbols.
 

ScottK

Not out of the crisis
Leader
Super Moderator
Can you provide little more details about your product such like indented use, sterile or non-sterile?.

A couple of examples of what we currently print for US customers
-Films that is used to make a heat sealed peel-off cover for a plastic tray that contains a device
-Foil packette that is used to hold a small catheter type device

We don't sterilize. We print the package with materials such that it is able to be sterilized at the packaging site.

materials are usually specified, if not provided, by the customer. We supply the inks and varnishes and do the printing and winding.
 
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