The European Society of Minimally Invasive Neurological Therapy (ESMINT) has issued a call for experts in neurointerventions to work with notified bodies over the certification process of medical devices within the European Union (EU).
The society recently established a Medical Device Regulation (MDR) Task Force, chaired by ESMINT treasurer Christian Taschner (University Hospital Freiburg, Freiburg, Germany), with the aim of supporting the CE-certification process for neurointerventional medical devices by establishing a database of experts in this field.
As noted in a recent ESMINT press release, these experts will work with EU notified bodies—organisations designated by EU member states or through specific agreements to assess the compliance of medical devices before they reach the market—providing technical input and advice in the certification process. According to ESMINT, this addresses an “urgent need”: certification processes for medical devices in the EU are increasingly delayed due to a shortage of experts to advise notified bodies across Europe.
The society has therefore initiated a call for clinical experts who will be able to leverage their clinical and scientific expertise to participate in the CE-certification process of medical devices for neurointerventions. A database of experts will be compiled, and notified bodies will be able to select experts according to their particular areas of expertise in the neurointerventional field. ESMINT details in its recent release that, in collaboration with the engineers and technicians at the notified bodies, these experts will ensure a comprehensive evaluation of medical devices, ultimately guaranteeing the safety of users—both patients and doctors alike.
“This initiative highlights ESMINT’s unique role in the field and in Europe,” said ESMINT president Zsolt Kulcsár (University Hospital of Zürich, Zürich, Switzerland). “And, Professor Taschner is singularly qualified to move this forward, given his role at the European Medicines Agency’s [EMA] Expert Panels, where he serves as member of the coordination committee as well as vice-chair for the expert panel on vascular implants.”
