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Examples of "quantitative" information on implant materials to provide in IFU (GSRP 23.4u)

  • 1.  Examples of "quantitative" information on implant materials to provide in IFU (GSRP 23.4u)

    Posted 11 days ago

    EU MDR GSPR 23.4(u) states the instructions for use shall include "in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed"

    My company manufacturers a PMMA implant coated with a copolymer and several metals. We would prefer to not disclose the exact, quantitative (proprietary) material composition (e.g., X ug of metal A, Y ug of metal B, Z mg of PMMA).

    Can anyone provide examples of quantitative information from other CE marked device labeling that I could use to guide how to fulfill this requirement without divulging our secret sauce?



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    Mark Mortellaro, Ph.D., RAC-Devices, RCC-MDR
    Sr. Principal Regulatory Scientist
    Maryland, USA
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  • 2.  RE: Examples of "quantitative" information on implant materials to provide in IFU (GSRP 23.4u)

    Posted 10 days ago

    Hello Mark,

    In the past I had used percentages of total amounts together to describe the material composition. The other way is to only state qualitative composition of the materials, indeed indicating exact amounts of materials would disclose proprietary and confidential information.  Now to practicality the regulation has lost ... the intent is to clearly convey information for which the patient would be exposed over a short period of time or long period of time.  Most like 80% of patients do not ask, nor care.  However, it is important if there are any potential reactions or fear of a type of material, then at least they can make an informed decision if they want that PMMA material or titnaium or tungsten sitting inside their body for a few years.  Importantly, it should also be conveyed the biological evaluation how the materials have been tested, potential or probability of leaching substances, or any other long-term exposure a patient might be concerned about.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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