If you are developing AI-driven medical devices, you are working on two big challenges, building the technology and getting it approved. In addition to MDR compliance, the EU AI Act 2024/1689 adds an additional layer of regulation, introducing specific requirements around algorithm transparency, human oversight, and risk classification. If you don't consider the regulatory landscape early on, you are running the risk of slowing down your go-to-market timeline, stretching limited resources, and increasing regulatory hiccups.
The overlap of the two regulations creates new questions:
- What does the EU AI act 2024/1689 state about AI regulations in healthcare?
- Which AI systems are exempt from the AI Act?
- What are some prohibited AI practices relevant to medical devices?
- What are some differences between the AI Act and the MDR?
This white paper addresses these topics in detail and helps you make informed, compliance-ready decisions.
What you'll learn from this white paper
Whether you're developing diagnostic software, predictive analytics tools, or embedded AI in connected devices, this white paper cuts through the complexity. Inside, you'll find:
- A clear, concise summary of the AI regulations in healthcare
- A breakdown of how the EU AI Act 2024/1689 aligns or differs from existing frameworks like the MDR
- An overview of current conformity assessment pathways and how they support a stronger compliance foundation for medical AI systems
Download the white paper
Understand and get expert guidance on how the EU AI Act 2024/1689 impacts your AI-powered medical devices.
Download now and get started by filling out the form.
About the authors
Matthew Kirkman
Clinical Reviewer, Senior Product Specialist, Clinical Data and Subject Matter Expert, TÜV SÜD
