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).
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.
Online content related to our Online Forum can be accessed at Resources.