Artificial Intelligence

Efficient market access for artificial intelligence (AI)-based software: BAIM

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.

EU Regulatory Affairs and Liability Risks of AI-based Medical Devices

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.

Next-level security for AI-based software as medical device

To prove the safety and performance of AI-based software as a medical device, there are special documentation requirements due to data management and model development.

NB’s New Requirements for AI-based Software

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

Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine . Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
2019/05/02 - Artificial Intelligence - Updated: 2021/04/16 - Thorsten Prinz

Market Access for Artificial Intelligence in Medicine

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