Navigating Changing Waters: How to Keep Your AI-enabled Digital Health Software Compliant
Regulatory requirements such as the EU MDR/IVDR and the AI Act are constantly evolving. In Beni Hirt's presentation, you will gain insights into what you need to consider with your AI-based software in order to remain compliant in the current regulatory landscape.
The regulatory landscape for AI-powered digital health software is in a state of constant flux. The EU MDR and IVDR provide the framework, but the EU AI Act has introduced additional requirements for the safety and ethics of AI algorithms. So has the new EHDR. Many companies are wondering how they can ensure the compliance of their medical software not only today, but also tomorrow.
In this presentation, you'll get an overview of the most important regulatory requirements of the EU MDR/IVDR and the EU AI Act, which influence your compliance strategy. We'll discuss how to correctly classify your AI-enabled software under both sets of regulations, the role of continuous monitoring, and how to plan the conformity assessment of your software, with a forward-looking approach.
At the end of this presentation, you will:
- become aware of the (uncertainty in the) concepts of “AI systems” and “General-purpose AI models” (GPAIM).
- get tips for high-risk medical device AI systems (MDAI) until CE-marking under the AI Act becomes applicable.
- be ready to consider the overlaps between the EU MDR/IVDR and the AI Act, as well as the EHDR, in your compliance strategy.
Note: This presentation was given in German.
Speaker
Beni Hirt, Decoplix AG, CEO
