Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.

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.

Manufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe: The fulfillment of the fundamental regulatory requirements for medical devices focusing on software and the Integration of special requirements for AI-based devices into the quality management system.

Notified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.

Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software.

Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!

You must understand the importance of protecting your trade secrets or the development of your medical software was useless!

How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.