Interview: Where Do New Reprocessing Rules Leave EU?
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.
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All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.
The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.