The Interaction of Regulatory Affairs, AI and Data Protection in Medical Technology

In the dynamic world of medical technology, it is essential to always keep an eye on the latest regulatory requirements. The introduction of the AI Act has led to new legal challenges but also new chances for medtech companies when using AI in the European Union.

In addition, however, the requirements of the MDR and data protection must still be complied with, particularly with regard to the handling of sensitive health data. But how exactly does the “magic triangle” of MDR, AI Act and the GDPR work in medical technology in the EU and in Germany?

During this webinar we will cover the following topics for the European and the German market:

• An introduction to the new AI regulatory framework and its impact on the medical device industry, especially risk classification, conformity assessment and certification.
• The importance of the AI Act for the development and use of artificial intelligence in medical technology and its interaction with the MDR, with a focus on the implications for companies operating in the EU and Germany.
• Data protection regulations for medical technology with AI and best practices for successful implementation.

Our experts will use a practical approach to explain how exactly the regulatory requirements of the AI Act interact with medical device regulations and what medtech companies need to consider. In addition, we will discuss the importance of data protection in this context and show how both manufacturers and users can use medical technology with AI in compliance with data protection regulations.

As a participant of the webinar, you will not only receive valuable insights and answers to your questions, but also the recording of the webinar, the slide deck and our exclusive white paper “The Interaction of Regulatory Affairs, AI and Data Protection in Medical Technology - 20 questions and answers”.