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Everything You Want to Know About UDI

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  • 1.  Everything You Want to Know About UDI

    Posted 16 days ago
    Edited by Ryan Connors yesterday
      |   view attached
    No replies, thread closed.

    I’m excited to announce our next RegEx Ask Me Anything session! On 17 April, join Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean for a Everything You Want to Know About UDI, RAPS members-only Q&A. They will present a quick overview of unique device identification (UDI) requirements and timelines, and then will address topics submitted by you!

    Bring your questions about UDI labeling requirements, GUDID, EUDAMED implementation, and anything else related to UDI. We look forward to seeing you there. 

    If you have a question, please go ahead and submit it as a reply to this post. I hope to see you there (virtually) on 17 April! 

    (Note: there is no video element to this event.)

    This event is happening now! Please visit this link to ask questions: https://connect.raps.org/discussion/our-members-only-ask-me-anything-session-on-udi-starts-now#bm5b433848-3dc7-4959-996e-386c997276c3

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    Ryan Connors
    Social Media and Communications Specialist
    RAPS
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    Attachment(s)



  • 2.  RE: Everything You Want to Know About UDI

    This message was posted by a user wishing to remain anonymous
    Posted 15 days ago
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    This message was posted by a user wishing to remain anonymous

    Which countries have public-access databases? (EU, US, GB, any others?)




  • 3.  RE: Everything You Want to Know About UDI

    This message was posted by a user wishing to remain anonymous
    Posted 15 days ago
    No replies, thread closed.
    This message was posted by a user wishing to remain anonymous

    Which jurisdictions have UDI requirements already in force, and which others are expected soon?

    Which jurisdictions let manufacturers submit their own database records, and which require in-country reps to handle the uploads?




  • 4.  RE: Everything You Want to Know About UDI

    Posted yesterday
    Edited by James Gianoutsos yesterday
    No replies, thread closed.

    Thank you for your question!  We have answered it in our new thread: https://connect.raps.org/discussion/our-members-only-ask-me-anything-session-on-udi-starts-now#bm5b433848-3dc7-4959-996e-386c997276c3



    ------------------------------
    James Gianoutsos
    Founder & CEO
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------



  • 5.  RE: Everything You Want to Know About UDI

    Posted yesterday
    Edited by James Gianoutsos yesterday
    No replies, thread closed.

    Thank you for your question!  We have answered it in our new thread: https://connect.raps.org/discussion/our-members-only-ask-me-anything-session-on-udi-starts-now#bm5b433848-3dc7-4959-996e-386c997276c3



    ------------------------------
    James Gianoutsos
    Founder & CEO
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------



  • 6.  RE: Everything You Want to Know About UDI

    This message was posted by a user wishing to remain anonymous
    Posted 15 days ago
    No replies, thread closed.
    This message was posted by a user wishing to remain anonymous

    Do you know of any objective measures for data quality? Both EUDAMED and GUDID seem to have a significant proportion of gobbledegook.




  • 7.  RE: Everything You Want to Know About UDI

    Posted yesterday
    No replies, thread closed.

    Thank you for your question!  We have answered it in our new thread: https://connect.raps.org/discussion/our-members-only-ask-me-anything-session-on-udi-starts-now#bm5b433848-3dc7-4959-996e-386c997276c3



    ------------------------------
    James Gianoutsos
    Founder & CEO
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------



  • 8.  RE: Everything You Want to Know About UDI

    Posted 6 days ago
    No replies, thread closed.

    Is there a small space or technology limitation exemption available in the EU for the UDI direct marking requirement?   If so, what is the process to apply for this exemption?    



    ------------------------------
    Kathie Goodwin RAC
    Senior Director, Global Regulatory Affairs, Drug Delivery and Digital Health
    Eli Lilly - ENTERPRISE
    Indianapolis IN
    United States
    ------------------------------



  • 9.  RE: Everything You Want to Know About UDI

    This message was posted by a user wishing to remain anonymous
    Posted 2 days ago
    No replies, thread closed.
    This message was posted by a user wishing to remain anonymous

    Some questions related to the EU market -

    What are the important rules/limits on UDI generation and those data inputs required for medical devices in EUDAMED?

    What is the projected timeline for UDI EUDAMED module to go mandatory?

    Will there be UDI information that is publicly accessible?

    I understand the UDI module is not yet mandatory however in a case where you register the required UDI information and you need to re-register due to an original error in the input data or a change in the UDI-DI, will EUDAMED have a function that will allow the manufacturer to make these changes?




  • 10.  RE: Everything You Want to Know About UDI

    This message was posted by a user wishing to remain anonymous
    Posted yesterday
    No replies, thread closed.
    This message was posted by a user wishing to remain anonymous

    If a manufacturer produces both diagnostic grade and educational purpose anatomical models for orthopedic surgeries, would the anatomical models created for education and research need a UDI?




  • 11.  RE: Everything You Want to Know About UDI

    This message was posted by a user wishing to remain anonymous
    Posted yesterday
    No replies, thread closed.
    This message was posted by a user wishing to remain anonymous

    If there's been a transfer of ownership and the legal manufacturer changes, does that trigger a new UDI-DI for registered devices?