Regulatory Open Forum

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  • 1.  CE Marking

    Posted 01-Aug-2013 14:18
    If a company has a custom equipment group that wants to start CE Marking their products (medical or non-medical) do they need to be listed under the companies ISO cert?

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    Robert Martin
    Project Manger
    Chart BioMedical
    Ball Ground GA
    United States
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  • 2.  RE:CE Marking

    Posted 04-Aug-2013 21:48
    Robert,

    By customer equipment group do you mean "procedure packs or systems"? If yes then, for class I sterile and above medical devices, yes for EU and AU.

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    Romit Singh
    Regulatory Affairs Associate
    Device Technologies Pty Ltd
    Frenchs Forest
    Australia
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    Original Message


  • 3.  RE:CE Marking

    Posted 05-Aug-2013 08:49
    Romit,

    I didn't mean customer equipment I meant custom. For example, if a company has customized products that can become a components of a system and want them to be CE marked under the Pressure Equipment Directive, does the facility that makes this product need to be under an ISO cert?  

    Thanks,

    Bob

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    Robert Martin
    Project Manger
    Chart BioMedical
    Ball Ground GA
    United States
    -------------------------------------------






    Original Message


  • 4.  RE:CE Marking

    Posted 05-Aug-2013 08:57
    Romit,

    I believe I found the answer!  

    "Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Community and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this section."

    Pardon the confusion. I should have downloaded the directive when I was asked the question.

    Thanks,

    Bob

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    Robert Martin
    Project Manger
    Chart BioMedical
    Ball Ground GA
    United States
    -------------------------------------------






    Original Message