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.
Bigs you is off your meds again. I can hear the doctor talking to the grieving window or widower. I'm sorry Mr/mrs Jones. We have to cut open your dead spouse to take out the pacemaker. That will go over real well. It will probably cost more to refurbish and decontaminate than put in a new device. Oh hears my favorite- Mr/Mrs Jones we have to RIP(not rest in peace) but RIP open your spouses chest to get that VLAD product out. LMAO