Regulatory Open Forum

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  • 1.  Surgical Instrument Cleaner & Lubricant

    Posted 23-Aug-2016 15:47

    I would like to know your opinions regarding all oil/lubricants according EU regulations.

    Do you consider them medical devices and CE mark their container labels? 

    Can you please help me with some opinions based on your practice?

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    Orjada Dervishleri
    Regulatory Affairs Associate
    Saint Petersburg
    United States
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  • 2.  RE: Surgical Instrument Cleaner & Lubricant

    Posted 24-Aug-2016 09:01

    Hello Orjada. If the devices are marketed for cleaning/lubricating medical devices, they are also devices themselves and should be CE marked as appropriate. 

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    [David] [Ledwig] [RAC]
    [Principal Consultant]
    [Practical Complliance, LLC]
    [Brevard] [NC]
    [USA]

    Original Message


  • 3.  RE: Surgical Instrument Cleaner & Lubricant

    Posted 24-Aug-2016 10:34

    Hello Orjada,

    There is guidance specific to Surgical Instrument Decontamination products in the MEDDEV 2.4.1 document as well as the Manual On Borderline and Classification in the community Regulatory Framework for Medical Devices".

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    Rohan Shah
    Raleigh, NC

    Original Message