Neurointervention Experts for EU Medical Device Regulation
ESMINT has established a comprehensive Database of Experts in Neurointerventions to collaborate with Notified Bodies in the certification process of medical devices within the European Union (EU). This initiative provides access to independent clinical experts with specialized expertise in neurointervention.
Scope of the project
ESMINT recently established a Medical Device Regulation (MDR) Task Force, chaired by ESMINT General Secretary, 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 can leverage their clinical and scientific expertise to participate in the CE certification process of medical devices for neurointerventions. A database of experts has been compiled, allowing Notified Bodies to select experts according to their specific areas of expertise within the field of neurointerventions.
In collaboration with 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 healthcare professionals.
Prof. Dr. Christian Taschner
For Notified Bodies: Request Access to the Database
If you are a Notified Body and require access to the ESMINT MDR Expert Database, please contact us at birgit.amend@esmint.eu.
The database provides:
- A pool of independent, qualified clinical experts in neurointerventions.
- Detailed profiles, including areas of expertise and CVs.
To request access, simply provide the first name, last name, and email address of the individual requiring access. Personalized log-in credentials will then be provided.
When contacting an expert from the database, we recommend using the subject line:
“ESMINT MDR Expert Database” to ensure clear communication.
For further questions or support, please do not hesitate to reach out.
Birgit Amend
For Industry: Enhance the CE Certification Process
When submitting a dossier for CE certification to a Notified Body, we strongly recommend requesting the involvement of a relevant expert from the ESMINT MDR Expert Database in the review process.
By involving an ESMINT Expert:
- Your medical product will be reviewed by a professional with specific knowledge in the intended field of application.
- This can significantly improve the likelihood of a thorough and clinically relevant evaluation.
Contact your Notified Body to discuss the inclusion of an ESMINT expert in your certification process.
Call for Experts: Join our Database
We are continuously expanding our database and invite qualified experts in neurointerventions to join our pool.
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
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.
Already an expert in the ESMINT MDR Expert Database?
If you are an existing expert in the ESMINT database and need to update your profile or contact details, please get in touch with birgit.amend@esmint.eu.