Provided that an AI-based software has a medical intended purpose, it is subject to the regulations 2017/745 (MDR) or 2017/746 (IVDR) in the EU. To help manufacturers of AI-based software in medicine dealing with the ever-increasing stringent requirements for market access, the VDE has developed the regulatory approach “BAIM – Boost AI to Market”. In this blog post we explain the respective background.
Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.
We help you to integrate your cybersecurity management into your risk management. In cooperation with you, we establish fast, simple and user-friendly processes with which you can independently examine your product not only for physical hazards in terms of operational security, but also for weak points in information security and eliminate them.
VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.
MeSo stands for Medical Devices and Software. Find out why the VDE provides this platform.
