Regulatory Open Forum

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  • 1.  Labelling

    Posted 22-Dec-2020 19:36
    Dear RAPS members,

    Our company manufactures eye diagnostic device (class IIa). We would like to add shockwatch label outside the packaging as an improvement in our shipping process .Will this be considered as significant change?

    Looking forward to your thoughts.

    Regards,
    S.Rajesh



    ---------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager

    Den Haag
    Netherlands
    ---------------------------------


  • 2.  RE: Labelling

    Posted 23-Dec-2020 06:28

    Hello Soumya,

    I would not think so ... while this is most likely addressing a risk control for protection of the device during transit, it is not a specific warning for user from a safety perspective.  What you said is the key word, 'improvement' which if not related to safety or performance most likely would not be considered a significant change.



    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: Labelling

    Posted 24-Dec-2020 04:14

    Hello Soumya,

    I fully agree with Richard.



    ------------------------------
    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
    ------------------------------

    Original Message


  • 4.  RE: Labelling

    Posted 25-Dec-2020 11:08

    Hi Soumya,

    Keep in mind, in general, that changes which do not affect the safety or performance and just "improve" the device are not significant changes.

    Of course, any change should go through your risk management process, which will reveal how it affects your system.



    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 5.  RE: Labelling

    Posted 28-Dec-2020 11:01
    Edited by Scott Bishop 28-Dec-2020 11:01

    I agree with the information provided already but I wanted to add that this may be an opportunity to refine your process and procedures to more clearly identify a significant change.  

    Don't waste the opportunity for process refinement when facing a change that raises a question!



    ------------------------------
    Scott Bishop
    Houston TX
    United States
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    Original Message


  • 6.  RE: Labelling

    Posted 06-Jan-2021 08:36
    Is this change due to a complaint CAPA? Did the device fail to meet its design requirements because it lacked this?

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device

    DOD/DARPA/Dept Veterans Affairs Design Controls in Research

    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 7.  RE: Labelling

    Posted 07-Jan-2021 09:52
    Adding the Shockwatch label to the package is not a change to the device or its packaging.  As such, I would not call it a significant change to the device.  I see this change as post market surveillance.

    ------------------------------
    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
    ------------------------------

    Original Message


  • 8.  RE: Labelling

    Posted 07-Jan-2021 10:29
    Dear Al van Houdt

    Thanks for your valuable feedback!

    Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 9.  RE: Labelling

    Posted 07-Jan-2021 11:21
    Dear Ed Panek,

    The change is not a result of any CAPA. It was initiated to avoid mishandling by forwarders. More of business risk mitigation than product safety.

    Regards

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 10.  RE: Labelling

    Posted 08-Jan-2021 04:13
      |   view attached
    Hi Soumya

    Hello, maybe it would be  also good to look at the document issued by EU Comm -MDCG concerning significant changes.
    MDCG 2020-3:
    Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD


    ------------------------------
    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
    ------------------------------

    Attachment(s)

    pdf
    Guidance on significant changes & annexes.pdf   1.03 MB 1 version
    Original Message


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