The European Society of Minimally Invasive Neurological Therapy (ESMINT) issues a call for experts in neurointerventions to work with notified bodies in the certification process of medical devices within the European Union (EU).
Christian Taschner
ESMINT recently established a Medical Device Regulation (MDR) Task Force, chaired by ESMINT Treasurer, Professor Dr. Christian Taschner, University Hospital Freiburg, Germany. The aim of this Task Force is to support the CE certification process of medical devices in neurointerventions by establishing a database of INR experts in the EU collaborate with notified bodies* across Europe to provide expert input and advice in the certification process.
This addresses an urgent need: certification processes of medical devices in the EU are increasingly delayed due to a shortage of experts to advise notified bodies across Europe.
ESMINT 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 the notified bodies will be able to select experts according to their particular areas of expertise in the field of neurointerventions.
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,” commented ESMINT President, Dr. Zsolt Kulcsár (Head of Neuroradiology, University Hospital, Zurich, 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.”
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*Notified bodies play an important role in the conformity assessment of medical devices in the EU. These organizations, designated by EU Member States or through specific agreements, are responsible for assessing the compliance of medical devices before they reach the market. Their primary objective is to ensure that these devices meet the essential technical requirements outlined in European directives and / or regulations.
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Read and download here the Call for Experts Press Release as PDF.