EU AI Act for Pharmaceuticals and Medical Devices

Since August 2026, Regulation (EU) 2024/1689, the EU AI Act, applies to every one of the GxP-regulated systems, and most life sciences AI lands in the high-risk tier. Get it wrong and the bill is up to €35 million or 7% of global turnover, a refused CE mark or a product withdrawal. An unclassified AI system is an inspection finding. This two-hour online training turns the Act into one clear method: classify, comply, prove.

Across ten lessons, this certified course covers every part of the Act with six step-by-step procedures and four real cases, from scope and the risk pyramid to conformity assessment, general-purpose AI and enforcement. Its traceable certificate gives you audit-ready proof that you, or your team, are ready to apply the EU AI Act in practice.

Why teams choose this course

• Built with European regulatory affairs and AI compliance experts
• Six step-by-step procedures: reach and deadlines, Article 6 exceptions, Article 25 role triggers, Article 50 transparency, the FRIA, your first ninety days
• Real cases: IBM Watson for Oncology, the Epic sepsis model, Babylon’s symptom checker, the Optum care-management algorithm
• Full lifecycle, from risk classification to CE marking and post-market monitoring
• One-year access per learner and a CPD/CEU certificate your QA can verify online

What you’ll learn

• Classify any AI system by risk tier and confirm high-risk status under Article 6
• Apply the seven requirements for high-risk AI, Articles 9 to 15
• Map who does what: providers, deployers, importers and distributors
• Align the Act with the MDR, IVDR, GxP and data integrity rules
• Build a conformity file that passes EU inspection and audit

Who should enroll

• Regulatory affairs and quality assurance teams
• AI, data science and computerised-systems owners
• Medical device and IVD manufacturers deploying AI
• Clinical, pharmacovigilance and manufacturing leaders

Upon successful completion, each learner receives a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum

Lesson: A Brief History of AI Regulation in Life Sciences

Lesson 1: Foundations of the EU AI Act

Lesson 2: The Risk-Based Pyramid and Prohibited Practices

Lesson 3: Is Your System High-Risk? The Classification Rules

Lesson 4: The Seven Requirements for High-Risk AI

Lesson 5: Roles and Responsibilities Across the AI Value Chain

Lesson 6: AI as a Medical Device, Where the AI Act Meets the MDR and IVDR

Lesson 7: AI in Drug Development, Clinical Trials and Pharmacovigilance

Lesson 8: Conformity Assessment, CE Marking and the Fundamental Rights Impact Assessment

Lesson 9: General-Purpose AI and Foundation Models in Life Sciences

Lesson 10: Governance, Enforcement and Building Your Compliance Program

Conclusion

Glossary

Final Assessment