How to Achieve Market Approval Under the new Medical Device Regulations
What does a medical or diagnostic device need to fulfill to be commercialized in Europe?
Medical devices (MD) as well as in-vitro diagnostic devices (IVD) cannot be placed on the European market without conforming to the strict safety requirements of the European Union. These are regulated by the Medical device regulation (MDR) and the in-vitro diagnostic regulation (IVDR).
In this Online Educational Forum Lecture "Regulatory Requirements for Medical Devices in Europe – How to Achieve Market Approval Under the new Medical Device Regulations", Dr. Sebastian Grömminger, Consultant for the approval of in-vitro diagnostics @ Johner Institut GmbH, will help you to understand today’s EU regulation requirements and its basic implementation lines.
The online lecture aims at
- giving an overview of the regulations MDR / IVDR (EU 2017/745 and 2017/746)
- getting familiar with basic safety and performance requirements of the completely revised and extended Annex I of the MDR and the IVDR
- learning about Quality Management and how to structure Technical Documentation
We currently offer two public Lecture Series, which alternate each month:
The SPARK-BIH Educational Forum is designed to teach academic scholars the principles of Drug, Device & Diagnostic Development with focus on topics which are relevant for translational medicine.
In our SPARK-BIH Entrepreneurial Forum we recruit key opinion leaders in the fields of Business Planning & Development, Financing and Commercialization to teach entrepreneurial scientists.
SPARK-BIH is a mentoring program that supports academic inventions with education, mentorship and funding. The program is designed to de-risk projects with high potential impact, addressing critical unmet medical needs for any medical indication. Our aim is to accelerate the translation of academic inventions into outstanding medical products including novel drugs, repurposing drugs, advanced therapy medicinal products, such as cell and gene therapies, diagnostics and medical devices.