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New chapter 4.2.3 Medical Device file

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by DarisQ, May 9, 2016.

  1. DarisQ

    DarisQ New Member

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    Hi there,
    In the 2016 revision, there is a new chapter 4.2.3 Medical Device File.
    My company is not producing any Medical device, but only components that may be used on a medical device (that's why we are ISO 13485 certified, our customers are medical device manufacturer). With the older version of the ISO 13485 standard, there was no clear requirement on having such Medical device file, but now, as it is a requirement. I was wondering if I can consider the chapter as not applicable as we do not produce medical devices but only componnents.
    Thanks
    Daris
     
  2. Pads38

    Pads38 Member

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    I have yet to read the standard, but a white paper on the changes landed on my desk today.

    From that the relevant part states:
    So, rather than saying all of 4.2.3 is N/A, it may be better to have an MDF covering as many sections of that list as you can.

    Source is an EMERGO white paper here:
    http://www.emergogroup.com/resources/articles/white-paper-updates-to-iso-13485-standard
    (Free registration required)
     
  3. DarisQ

    DarisQ New Member

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    Thanks. As suggested, I created a chapter to cover the main sections listed on the standard.
     
  4. rob73@work

    rob73@work New Member

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    I would contact your CB and customer before getting to bogged down with creating new files. As a medical device manufacturer we are expected to create and maintain a device master file containing all of the list sections, but i would not expect our suppliers to do the same for components used in the manufacture of OUR devices. If on the other hand you are manufacturing a completed medical device and supply it to your customer you will be required to keep a file on the device AND share this information with your customer and vice versa, if this is the case i would suggest also looking into OEM agreements etc.
     

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  5. TerryMc

    TerryMc New Member

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    I have a client in exactly the same position. The new Standard states in Clause 1 (Scope): If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable... By my reading, then, you can only exclude elements from clauses 6, 7 or 8 and if you do, you have to provide justification; the requirement for a medical device file is in clause 4. I suspect the technical committee never really gave much thought to component suppliers. The other wrinkle is regarding risk management and ISO 14971.
    There are different approaches one could take. One approach might be to have an MDF that simply states that the organization does not produce any medical devices. This is possible where the components are all catalog or 'off the shelf' items with no customization.
    Where there is customization, another approach could be to identify the customer's medical device and manufacturer in the MDF and describe the intended use of both the medical device and how the component is to be used in the medical device. You would need to work with the customer for the Risk Management File.
     

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