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Scope of the project

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.

Call for experts

ESMINT is looking for individuals who meet the following criteria:

  • Qualified physicians specialized in Radiology/Neuroradiology, Neurosurgery, or Neurology.
  • Minimum of 5 years of hands-on experience in neurointerventional therapy.
  • Currently practicing in the field of neurointerventional therapy.

To be eligible for consulting with the notified bodies, the following information is required:

  • Contact details
  • CV
  • Medical specialist certificate
  • List of interventions and techniques you are using in your current practice
  • List of medical devices you are currently using
  • Consent declaration stating that ESMINT is permitted to share personal data with third parties – limited to Notified Bodies in Europe

Process

Notified bodies will select physicians from the ESMINT database according to their area of expertise. A contract between the expert and the notified body will be established, addressing – among other things – confidentiality aspects, conflicts of interest and remuneration. The expert will review the data submitted by the industry and issue a medical opinion.