VDE Medical Devices and Software

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.

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.

The U.S. President has signed an Executive Order to strengthen the cybersecurity of government entities. The implications extend beyond government entities.

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.

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