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  • 1.  Medical Device File

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jul-2018 09:37
    This message was posted by a user wishing to remain anonymous

    Hello,

    We are a medical device company that relabels and repackages class I and class II medical devices. Since we are not the specification developer and do not have access to line drawings, bio testing etc., what is needed in the medical device file for each family we repackage and relabel? Thank you very much for all of your time and I look forward to any replies.


  • 2.  RE: Medical Device File

    Posted 28-Jul-2018 12:33
    I am going under a little assumption that you are taking other medical devices, putting some together into same package or taking bulk and labeling/packaging this thus falling under the repackager/relabeler where you did not physically make the original device.  The Medical Device File (MDF) (or DMR if living also in FDA world) would at a minimum reference the regulatory approval for the device that you are repackaging/relabeling, such as a FDA 510(k) number or having a CE Certificate on file.  Again this is assuming that you are not the manufacturer of the original device, so you need to show in the file that the device is acceptable to place on the market in the other country.  Then the MDF would have references or all of the labeling specification, packaging specifications, work instructions for labeling and packaging, distribution methods.  This may also include any shipping validations that are performed.  In essence your MDF would include all of the information that you are conducting for the device from the point you receive at your facility ready for relabeling/repackaging.  Hope that helps, but the answer to the question can be a bit more elaborate that maybe can not be conveyed in a few lines of text.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: Medical Device File

    Posted 28-Jul-2018 14:23

    In dealing with a DMR/MDF, it is important to remember they come in three (or four) flavors. By this I mean that the required content changes with the regulation or standard. Implementing one flavor does not guarantee conformance with any other flavor.

    The three clear requirements are 21 CFR 820.181, ISO 13485:2016 4.2.3, and EN ISO 13485:2016 4.2.3.

    Also, check CEN/TR 17223:2018 searching for 4.2.3.

    Extract the requirements for each case and determine which ones apply to your situation. Remember that you can tailor the QMS as necessary.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: Medical Device File

    Posted 29-Jul-2018 01:59
    In dealing with the EU MDR (Medical Device Regulation) all should be starting to plan for and do gap analysis from a TÜV SÜD training I was just at in San Diego it sounds like being a <g class="gr_ gr_264 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="264" data-gr-id="264">relabeler</g> or repackager is unlikely to work as you would not be able to meet all the requirements of the MDR how written.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 5.  RE: Medical Device File

    Posted 01-Aug-2018 09:41
    The effect of removing private labeling from the medical device industry is not yet explored. This seems like a radical choice.

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    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States
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    Original Message


  • 6.  RE: Medical Device File

    Posted 01-Aug-2018 09:49
    Leonard,

    I would be interesting in knowing whihc EU-MDR requirements would potentially block being a relabeler or repackager 

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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


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