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  • 1.  Device Master Records

    Posted 02-Jan-2024 14:21

    Hi - I'm creating Device Master Records, and in doing so, I'm listing out the different materials our devices are comprised of, and who supplies each material. One supplier has provided me with an SDS that states the material is a proprietary mixture.  Is stating ' Proprietary Mixture' acceptable on the DMR?  



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    Daniel Warf
    Tonawanda NY
    United States
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  • 2.  RE: Device Master Records

    Posted 02-Jan-2024 18:20
    Edited by Rupali Natekar 02-Jan-2024 18:20

    Hi Daniel, 

    In DMR creation, providing precise and accurate details is crucial. If the supplier's SDS indicates a proprietary mixture, it is generally acceptable to use the same term in the DMR. However, it will be good to provide more details in the DMR about the supplier, the material, and relevant SDS information.

    the above recommendation holds, particularly when the material is non-patient-contacting. In cases where the material is patient-contacting, the response would differ. 

    I hope this is helpful!



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    Rupali Natekar
    Regulatory Affairs Specialist
    Medtronic Diabetes
    Northridge CA
    United States
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    Original Message


  • 3.  RE: Device Master Records

    Posted 03-Jan-2024 04:10

    Daniel,

    Yes, it is ok to specify that in a Device Master Record (DMR) - also known as the Medical Device File (MDF) in ISO 13485 - the material may be proprietary or composition is confidential with a supplier.  There can be a general description of the material such as titanium alloy or polymer plastic, then indicating the exact material composition is proprietary.  As most DMR/MDF are more of an "index" pointing to certain items, pointing to the suppliers Safety Data Sheet (SDS) or other specification sheet would be proper and should be sufficient.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 4.  RE: Device Master Records

    Posted 05-Jan-2024 13:47

    Yes, in general, yet only commensurate with the risk and nature of the subject device, it is acceptable to state 'Proprietary Mixture' for the composition/formulation specification in the DMR.  In such case, yes, an MSDS would generally be included.

    However, beyond the MSDS, I generally advise against including further supplier information in the DMR.  Inclusion of further supplier details/information in the DMR would cause the DMR (or ISO 13485 MDF) to exceed the intended content for this document, consequently making for a DMR / MDF that is bloated with information not required and thus increasing the burden on your QMS/regulatory mechanism.  Moreover, convoluting the DMR / MDF with such supplier information infringes upon, and thus could create nonconformities with respect to, the the 820.50 / ISO 13485 7.4 requirements.



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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 5.  RE: Device Master Records

    Posted 05-Jan-2024 21:32

    I think you are making too much work.

    I infer that you are working on 820.181(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications.

    The DMR doesn't require the name of the supplier or any information that you get from an SDS. By including this information you duplicate information that is required by 820.50. This creates a maintenance problem. You have two sets of data each of which claims to be definitive, but over time they will diverge. For component specifications,  point to the part number in the BoM. This should lead to the 820.50(b) Purchasing data which is under document control.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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