Translation Requirements on Medical Device Packaging Labels

[Jwreeves]

Looking to get confirmation and a reg/standard to confirm if translations are required on outer and inner packaging labels.

Product is sterile OR product. It has outer carton and inner tyvek pouch. Both have complete labels.

I know translation of product descriptor is required on outer package. However, looking to confirm if it is required on inner poly/tyvek pouch.

We are moving product into EU and ROW and want to confirm where translation of descriptor is needed. My experience is that is it requried on outer carton adn not on tyvek pouch?

Can anyone provide definitive answer and documentation to back up? Thanks in advance.

[MIREGMGR]

The regulatorily critical labeling is that which is available to the end user as near as possible to the location and time of use. For a sterile OR product, that's the pouch label.

Generally for such products, the box label is considered to be equally important because product distribution external to and within use facilities affects its availability for use, and critical activities such as recalls may be implemented with respect to box labels in the case of not-yet-shelved inventory.

So: if translation is required, it's required for both pouch and box labels. This is industry standard, in my experience, and applicable across all regulatory systems.

[cochranemurray]

I think your query is covered by MDD93/42/EEC section 13b. "the details strictly necessary to identify the device and the contents to the user". If English was not the users first language, it could be argued that translation was necessary.

[nwong]

Takenn from MDD 93/42/EEC section 13.1 states, "Each device must be accompanied by the information needed to use safely and properly , taking account of the training and knowledge of the potential users..." I believe if you can justify that the translated outer packaging is sufficient information to use the device "safely and properly," the inner packaging translations aren't necessary. If information is unique to the inner packaging, I would think its translation is necessary.

I think cochranemurray's statement can also be read in this way.

[Jwreeves]

Thank you all for input on this matter. I do believe that in our case inner packaging translation is not needed.

[J0anne]

http://www.isomedical.co.uk/#/labelling/4548638258

Here's a list of requirements and it will be updated in the next few days.