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Sunshine Heart Inc. Message Board

  • bigsmartsta bigsmartsta Nov 25, 2013 12:03 PM Flag

    EU May Require Medical Devices To Be REUSED!! Large Ramifications For Revenue

    “In the future all medical devices could, by default, be reusable - that has huge implications for safety”
    From an email I received early this morning. It appears the EU medical device industry may be headed for chaos. Some snippets of the email.
    ------------------

    “In the future all medical devices could, by default, be reusable - that has huge implications for safety

    The industry trade bodies have been working hard to ensure a successful outcome to negotiations but there is still, of course, the likelihood of a vastly different regulatory system come 2015/16 when the legislation will be implemented.

    If the negotiations fail then industry will need to start saving; a Eucomed commissioned survey foresees additional annual costs for a SME of bringing a Class III product to market of €17.5m annually. Expect significant and potentially costly legal challenges as the new system is negotiated and trialled. Difficult customer conversations may need to be had. And, finally, expect a whole group of frustrated patients, no longer able to access the new knees, hips and heart valves that they once did.

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