Day Three – 18 June 2025Wednesday, 18 June 2025 - CEST Time Zone

With so much buzz around the EU AI Act, what actually is it and why is it so important for industry?

• Does it only affect manufacturers with AI-enabled devices?
• Is it already implemented and are there transition times?
• What implications are there for industry, notified bodies and regulators?
  
  
• Where does the AI Act sit within our regulations
  • Link to EU MDR / IVDR, GDPR, Cybersecurity, etc...
• What are the ethical considerations in regard to the AI Act
  • Importance of considering ethics for regulatory affairs teams
• Use cases

• Which special considerations are there for designing quality systems in line with the AI Act?
• Can manufacturers utilise their pre-existing system, or is a new one needed

• Does the AI Act describe data requirements?

  • Which evidence is required for certification under the Act?

  • How does this interact with data requirements from other regulations?

  • Does it differ based on device risk class?

  • How do you know if it is sufficient?

  • How do you ensure the data is GDPR compliance?

• Once desirable data has been identified, how do you collect this data and use it to support claims?
• Which types of studies are most effective for collecting data in regard to the EU AI Act?

• How does the EU AI Act interact with post-market surveillance and vigilance requirements?

  • Are there additional requirements which need to be considered?

  • How do you monitor post-market for non-static devices and diagnostics?

• Take this time to put together a mock submission for a device in line with the Act

• Compare and contrast with other workshop participants and gain invaluable feedback from trainers

• Open Q&A