InspireMD receives CE Mark recertification under E.U.’s new MDR framework

InspireMD announced that it has received CE Mark recertification under the European Union’s, EU, new Medical Device Regulation, MDR, regulatory framework. MDR replaced the previous MDD framework, which had governed the approval and marketing of medical devices in the EU until May of 2021. Marvin Slosman, chief executive officer of InspireMD, stated, “The transition from MDD to MDR has been challenging and has required us, and others in the medical device industry, to be comprehensive and persistent in our approach to addressing changes in requirements, timelines, and priorities during this process. We are very pleased to have now received formal recertification of our CE Mark under MDR, allowing us to continue to work to make CGuard EPS the standard of care for carotid artery revascularization in our existing commercial territories while also advancing our new product pipeline using the pathway provided under MDR.”