Questions over proper oversight and allowances for reprocessing of single-use devices in the EU caused significant debate among policymakers who developed the pending European Medical Devices Regulation. Reprocessing advocate Dan Vukelich talked to Medtech Insight about whether or not there will be an EU-wide approach to device reprocessing under the new rules, and more about the path forward for the practice.
“Frankly, as SUD remanufacturers now need to meet all the same MD requirements as any other manufacturer and await member states to affirmatively opt in, the standard for SUD remanufacturing is now higher than it is for most manufacturers…”
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