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Spare parts

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Udirn1, Feb 7, 2018.

  1. Udirn1

    Udirn1 New Member

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    Dear all,
    I work in a medical device company and would like to know whether there is a specific regulation within the directive which stipulates how long must a manufacturer of a medical device is obligated to keep spare parts once a device is declared as discontinued.i have failed to find such an accurate statement in the directive . Would appriciate your help.from my experience its common to hold parts for 7 years since last article left the manufacturing line but i find no support for it in the directive.
    Thanks
     
  2. Vintage Goose

    Vintage Goose Active Member

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    Hi, sorry, there is no Medical Device regulation that says how long you should hold spare parts.
    Chris
     
    Atul Khandekar likes this.

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