Join Our Webinar: EU AI Act & Digital Omnibus: Are Your AI-Driven Medical Devices Ready?
The EU AI Act for Medical Device Manufacturers. An Overview for the MedTech Industry Including Impact Assessment of the Digital Omnibus
Artificial intelligence is rapidly transforming medical devices — and EU regulation is setting new expectations for how these technologies are assessed and placed on the market.
The EU AI Act introduces new regulatory requirements that will directly affect AI-enabled medical devices. For manufacturers, the challenge is no longer if these regulations apply, but how to comply efficiently without slowing innovation or market access.
Webinar
„EU AI Act & Digital Omnibus: Are Your AI-Driven Medical Devices Ready?”
Date: Wednesday April 1, 2026
Time: 2:00–3:00 p.m. CET
In this webinar, our expert will provide a structured overview of:
- The EU AI Act and its current implementation status
- The impact of the Digital Omnibus on medical device manufacturers
- Role of Notified Bodies in the AI Act framework
- Conformity assessment requirements according to Annex VII of the EU AI Act
- The relevance of voluntary assessments in the regulatory landscape
This session is designed to support manufacturers in understanding regulatory frameworks and conformity assessment expectations, enabling informed planning and internal decision-making.
Meet the presenter:
Dr. Andreas Schwab: Global Head of Medical Software TCC, Senior Lead Auditor and Product Expert.
Dr. Schwab studied Biomedical Engineering with a focus on radiological systems and artificial intelligence at the University of Ilmenau (Germany) and Dundee (UK), and holds a doctorate in Medical Physics from Friedrich Alexander University in Erlangen. With over 12 years of experience in medical software development, he has spent more than five years at TÜV Rheinland in Nuremberg as a Lead Auditor and Product Expert under international medical device schemes such as ISO 13485, EU MDR, MDSAP, and UK MDR. He currently serves as Head of the Technical Competence Center for Medical Software, co-chairs the Team NB AI Task Force, and delivers training on AI Act requirements.
Don’t miss out on this valuable session - register today!
You will receive a confirmation of your registration by e-mail. After the event, we will provide you with the presentation as a download. For questions and further information, we are also available in advance.
There are no participation fees for you by participating in the events. In return for attending our webinar, we only request your contact details and your consent to receive regular e-mail updates on TÜV Rheinland products and news in the future. The fields marked with * are required for a region-specific contact to coordinate conversations. This enables us to process your inquiries quickly and competently.
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