Regulatory Open Forum

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  • 1.  Own Brand Labeling

    Posted 04-Nov-2015 09:52
    I am looking for some updates on expectations for the relationship between an OEM and an OBL.  I am aware that MHRA Bulletin 19 was pulled based on 2013/473/EU and at least two draft guidance docs have been proposed in replacement.  But  I have no further news.  Please advise if you have further details.

    Thanks
    Mitch


    ----------------------------------------------------
    Mitch Johnson
    Director, Regulatory Affairs
    IntriCon Corp
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  • 2.  RE: Own Brand Labeling

    Posted 04-Nov-2015 10:29
    Mitch,

    I suppose your questions relate to jurisdictional matters in EU.

    Under European Community directives, an own brand labeler becomes a legal manufacturer. Thus, CE mark/certification is required.

    It is recommended that own brand labelers plan their action ahead in view of updated ISO 9001 or pending to be updated/released for ISO 13485.

    My seminar on CE mark is available here.  

    Please note: 2015 version of Code of Conduct for NBs is available at http://regulatorydoctor.us/2015-code-of-conduct-for-notified-bodies-in-eu/ 

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 3.  RE: Own Brand Labeling

    Posted 05-Nov-2015 10:32
    Hi David,

    Thanks for your response.  I guess I was hoping someone has an update on the replacement to MHRA bulletin 19.

    Best regards,
    Mitch


    ----------------------------------------------------
    Mitch Johnson
    Director, Regulatory Affairs
    IntriCon Corp
    1260 Red Fox Road
    Arden Hills MN 55112 USA
    +1-651-604-9572
    ---------------------------------------------------





  • 4.  RE: Own Brand Labeling

    Posted 05-Nov-2015 10:41
    Mitch,

    The MHRA bulletin 19 has been withdrawn.

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.