Hands-on training Artificial Intelligence (AI) in Medical Devices

Artificial intelligence (AI)-based medical devices are subject to the European Regulations 2017/745 (MDR) or 2017/746 (IVDR) and in Germany to the Medical Devices Implementation Act (MPDG). The EU Artificial Intelligence Act (AIA) creates even higher barriers to market access. In addition, many AI-specific standards and guidelines are currently being published (e.g., by the German Notified Bodies Alliance IG-NB), and best practice methods for developing AI models are constantly being updated.  

The first challenge for manufacturers is to implement the development and evaluation of the AI model as processes in their quality management system in accordance with the relevant requirements. Other regulatory processes, such as software lifecycle and risk management, clinical evaluation, and usability, also need to be adapted to take account of AI-specific features.  

In our hands-on training, we first get to know a fictitious company and its AI-based medical device software. We consider the training and testing of a simple artificial neural network as an AI model, as far this is required for the regulatory handling of the product. Using this real and publicly available AI model with a medical purpose as an example we apply various regulatory templates (in English) step by step, which can later be transferred to your product. 

Dr. Thorsten Prinz (VDE, Offenbach/Main)