Regulatory Open Forum

 View Only
  • 1.  Packaging label

    This message was posted by a user wishing to remain anonymous
    Posted 08-May-2024 09:03
    This message was posted by a user wishing to remain anonymous

    Hello Expert, 

    Does packaging label for class I medical devices need to be in a closed sections, such as all elements of labelling in a closed section?

    we sell one device per one shipping box.

    Can we post SN and UDI in a different doc such as shipping slip/packing slip?

    Thank you



  • 2.  RE: Packaging label

    Posted 21-May-2024 15:03

    Hi there - I think a little more clarification is needed to help answer your question. What country are you referring to? I'm not sure what a closed section means? What is your product? Is it reusable or disposable? 

    I don't believe you can put a UDI number on packing slips. It has to either be on the product itself (for reusable) or on the shipping container (at least for most countries I am familiar with). 



    ------------------------------
    Beth Lentz
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------