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?

The regulatory landscape before the introduction of the EU AI Act vs now

• Which regulations do manufacturers need to be aware of in addition to the EU AI Act?

• How does the Act interact with EU MDR/IVDR, as well as data protection regulations?

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?

Collecting suitable data: a working example

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?

Are there any regulations or frameworks around ethics for AI, including in the EU AI Act itself?

What ethical considerations need to be taken into account?

• Algorithm transparency and bias

• Data protection and security

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