Vesalio has announced EU Medical Device Regulation (MDR) certification of its product lines—achieving this “significantly ahead” of its May 2023 deadline, according to a company press release.
This milestone is the third in a series of recent regulatory approvals of Vesalio’s neurovascular products following the CE marking of its Neva Net—a neuro-thrombectomy device containing a unique integrated distal filter technology—and the US Food and Drug Administration (FDA) humanitarian device exemption (HDE) approval of Neva VS, which is indicated for the adjunctive treatment of aneurysmal subarachnoid haemorrhage (aSAH)-induced cerebral vasospasm.
In the release, the company asserts that the past few years have seen regulations for medical device manufacturers become progressively complex and demanding. In Europe, the transition from the old Medical Device Directive (MDD) to the MDR has brought increased quality and regulatory demands, including additional clinical evidence of safety and efficacy, Vesalio claims.
“This new reality affects both the approval and post-approval processes, introducing stricter requirements for post-market clinical follow-ups,” stated Gustavo Prado, vice president of Development and Operations at the company. “This certification, along with our other recent regulatory milestones, showcases the focus and diligence of our quality and regulatory teams.”
“We are committed to our commercial partners working alongside us as we expand our product portfolio in Europe, MEA [Middle East and Africa], LATAM [Latin America] and Asia-Pacific regions while continuing to invest in further geographic expansion,” added William von Brendel, Vesalio’s vice president of International Business.