##  [EU AI Act Essentials for SaMD: What You Need to Know Before You Launch](/index%2ephp/fireside-chat/eu-ai-act-essentials-for-samd-what-you-need-to-know-before-you-launch) 

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## **EU AI Act Essentials for SaMD: What You Need to Know Before You Launch**



**The session successfully concluded with in-depth insights into AI-specific regulatory developments impacting SaMD.**

  **June 3, 2025**

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### **Topics Covered**

#### **Key discussion points include**

- EU AI Act and its relevance for SaMD
- Risk-based classification and required documentation
- Conformity assessment and regulatory strategy
- Software-first certification approach by Scarlet
- Actionable steps for proactive compliance

Freyr continues to host focused fireside chats on regulatory trends in life sciences. We look forward to welcoming you to our upcoming sessions.