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Article 12 Procedure Pack Labelling Requirements

Discussion in 'EU Medical Device Regulations' started by Amy G, Oct 2, 2018.

  1. Amy G

    Amy G New Member

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    Hi,

    After some advise.. we are manufacturers of procedure packs under article 12. For certain components that can not be sterilised or re-sterilised due to suppliers information provided we choose to 'piggy back' or package separately the component in a pouch attached to the main pack (after sterilisation)

    This now creates the main pack being sterile and the separate item non-sterile however as they are all placed in one carton, I am unsure on how best to label the outer case to reflect this.
    For the pouch itself, as per the requirements we list the contents and individual CE marks and we also apply the sterile EO or non sterile logo next to the item to indicate its sterility.

    However, for the outer case, we do not list contents. Only the ref code and description. Do you need to apply the sterility method to the outer case or is the pack packaging sufficient?

    thanks!
     

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