Vesalio’s Product Lines Receive European MDR Certification

October 13, 2022—Vesalio announced that its product line has received the European Union Medical Device Regulation (MDR) certification. The milestone was achieved significantly ahead of the May 2023 deadline, noted the company.

The company noted that in Europe, the recent transition from MDDs—Medical Device Directives—to MDRs has brought increased quality and regulatory demands, including additional clinical evidence of safety and efficacy.

Gustavo Prado, Vice President of Development and Operations at Vesalio, commented in the press release, “This new reality affects both the approval and postapproval processes, introducing stricter requirements for postmarket clinical follow-ups. This certification, along with our other recent regulatory milestones, showcases the focus and diligence of our quality and regulatory teams.”

William von Brendel, Vice President of International Business at Vesalio, added, “We are committed to our commercial partners working alongside us as we expand our product portfolio in Europe, Middle East & Africa, Latin America, and Asia-Pacific regions while continuing to invest in further geographic expansion.”

The company noted that other recent regulatory milestones include European CE Mark approval of the NeVa Net neurothrombectomy device, which features integrated clot microfiltration technology, and FDA approval under a humanitarian device exemption for the commercialization of the intracranial NeVa VS retrievable nitinol stent, which is indicated for the adjunct treatment of symptomatic cerebral vasospasm after aneurysmal subarachnoid hemorrhage.