Approval of software as medical device in Europe: Overview of the requirements and insights from practice

Manufacturers of software with a medical intended purpose are subject to many laws and other regulations in Europe. These are primarily the Medical Device Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR). Manufacturers must also comply with the relevant guidelines and technical standards. In addition, there are requirements from horizontal EU legislation such as the Artificial Intelligence Act (AIA) or the existing General Data Protection Regulation (GDPR) as well as from national legislation such as the Medical Devices Implementation Act (MPDG) in Germany.  

In this event, you will receive an overview of the requirements to be complied with from relevant laws, standards and directives. The theoretical basics will be supplemented by practical examples from the professional activities of the expert Dr Thorsten Prinz (VDE). The event format offers sufficient time for your questions and discussions. 

The presentations will be given in German. You will receive all presentation files as PDF (in English). As a special bonus, all participants of this event will receive a list of the requirements for medical devices as high-risk AI systems in accordance with the provisions of the Artificial Intelligence Act in PDF format. 

We are looking forward to your participation! 

Dr. Thorsten Prinz (VDE, Offenbach/Main)