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Extension to Scope

Discussion in 'EU Medical Device Regulations' started by Jo Campbell, Jan 14, 2016.

  1. Jo Campbell

    Jo Campbell Member

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    Hi All,

    We are designing a new device based on the technology of our existing device. The existing device consists of hardware and a consumable, and the new product is based upon the consumable part which will be controlled by the original hardware. I am compiling the Technical File and Essential Requirements Checklist for the new device and our extension to scope, but don't know quite what to include. I understand that I must include details of the parent device in the description of the product (which I assume to be the original hardware), but how much detail do I need to go into and is there anywhere else that it should be mentioned? Also, where do I mention the original consumable, as the verification and validation performed on this will ensure compliance of the new device to the Essential Requirements.

    I've read this back and even I'm confused! I hope someone understands where I'm coming from with this, as your help will be very much appreciated.

    Regards,

    JoCam
     
  2. Ronen E

    Ronen E Well-Known Member

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    I would just include a reference to the original technical file (hardware and consumable). No need to duplicate.

    Cheers,
    Ronen.
     
    Jo Campbell and Somashekar like this.
  3. Jo Campbell

    Jo Campbell Member

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    Thank you Ronen, that will certainly make things easier.
     

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