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  • 1.  MDR - Device BOM, Production

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jul-2023 09:04
    This message was posted by a user wishing to remain anonymous

    Hi forum,

    Please advise.

    We are in the process of compiling the technical documentation, and needed clarity around Device BOM- what is the expectation here? Is it only to include the BOMS at the  top level - assemblies and subassemblies or is it required at the component level, we have an active device.

    For the manufacturing section, if there are no critical processes involved, how detailed should the manufacturing process flow chart and procedures be? 

    thanks



  • 2.  RE: MDR - Device BOM, Production

    Posted 31-Jul-2023 13:09
    Edited by Rajeswari Devanathan 31-Jul-2023 13:10

    Hi,

    The BOM should list all the major assemblies and subassemblies that make up the device. This gives a high-level overview of the device's structure.

    For each subassembly, you should include a list of components used to build that subassembly. This provides more detail about the components that contribute to the functioning of each subassembly. In some cases, especially for complex devices, it may be necessary to provide the BOM at the individual component level. This means listing all the individual parts used in the device, including items like screws, resistors, capacitors, etc. Along with the list of components, the BOM should also include material specifications for each component. This information is crucial for understanding the materials' characteristics and compliance with regulatory standards.

    The BOM should cover all the components and materials used in the current version of the device. If there are variations in the device due to different configurations or models, you may need to document the BOMs for each specific variant separately.

    Regardless of the criticality of the processes, it is essential to have clear and well-defined procedures that ensure consistency and control throughout the manufacturing process.
    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 3.  RE: MDR - Device BOM, Production

    Posted 01-Aug-2023 01:47

    In addition to the reply by Rajeswari, I would also suggest using a risk based approach. There are three main risks that should be considered:

    1. Biocompatibility; parts that come into contact with users/patients must be fully identified and they must be addressed in the biocompatibility evaluation. 
    2. Device failure; if the notified body wants to verify the parts in the risk analysis that cover device failure, they need to understand how it is build. 
    3. Hazardous substances and waste management; the presence of certain substances may trigger other legislation and the notified body needs to be able to evaluate that. Therefore you must either go down to the smallest parts of the device, or have components or sub assemblies covered by relevant certificates.


    ------------------------------
    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 4.  RE: MDR - Device BOM, Production

    Posted 01-Aug-2023 04:23

    Hello Anon,

    The structure and content of the Manufacturing section of Technical Documentation for EU MDR compliance can vary significantly from device type to device type - and by the classification of the device.  It is more important to think of the Technical Documentation as an index or a structured approach for presentation of detailed information.  For the manufacturing process description this could be a narrative description, a tabular listing of steps in the process, or a flow chart with some explanation.  It is fairly high level in the Technical Documentation index file - again what is important is then referencing documents such as the Device Master Record/Medical Device File, work instructions, testing procedures, etc., which can then review further detail.

    The Bill of Material (BOM) in the Technical Documentation index file is either a reference to the listing which is in further detail or providing the first or second level of the BOM.  Putting in the whole BOM in the Technical Documentation index/file might be too much unless it is a less complex device.  It really depends though, because some electronic devices may need list of crucial components in the Technical Documentation or the composition of a medical device provided - there is no specific rule or guideline for what is in there.  Read the Technical Documentation file from the reviewers perspective to make sure it is understandable, clear, and has references to the further detail.  Then when submitting the Technical Documentation, work with your Notified Body to understand what level of documentation needs to be provided initially - such as providing the full indented BOM as a separate document in the submission.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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