EU Regulatory Affairs and Liability Risks of AI-based Medical Devices

Online event on May, 17th 2022

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Manufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe:

  1. Fulfillment of the fundamental regulatory requirements for medical devices focusing on software and
  2. Integration of special requirements for AI-based devices into the quality management system.

Moreover, new requirements are arising with the planned European AI act. Once the respective device is placed on the market manufacturers need to be aware of liability risks which could also be increased by the new European legislation. In this event, we will learn how manufacturers of AI-based medical devices can deal with European regulatory requirements and how to address liability risks in the most effective way.

Note: The event will take place with a minimum of 8 participants. If the minimum number of participants is not reached one week before the start of the event, we reserve the right to cancel it. In general, registration is possible until approximately 24 hours before the start of the event. Thank you for your understanding.


13:00Login, welcome and moderation
13:15How VDE-BAIM helps placing AI-based medical devices on the EU-market
Thorsten Prinz, VDE

• Regulatory requirements in key documents: Question Catalog “Artificial Intelligence in Medical Devices” by the Interest Group of Notified Bodies for Medical Devices in Germany as well as international AI Standards
• Regulatory strategy VDE-BAIM: Successfully adapting existing and introducing new regulatory processes
• Developments at European level: The AI Act
14:00Regulatory experience of a small manufacturer concerning an AI-based medical device
Leon Doorn, Aidence

• Lessons learned from the implementation of regulatory requirements
• Major focus during audits of the involved Notified Body
14:45Coffee break
15:00AI and Liability
Boris Handorn, Produktkanzlei

• Contractual and statutory product liability
• Developments at EU level: upcoming adaptation of liability rules to AI?
16:15Final discussion
16:30End of the event

Preliminary program. We reserve the right to make changes / adjustments.

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Merianstr. 28
63069 Offenbach am Main

Charlotte Fleißig
+49 69 6308 478