EU AI Act for Pharmaceuticals and Medical Devices

When an AI model misreads a scan or a sepsis alert fires too late, the harm can reach patients at scale, and regulators now hold the organization accountable. Regulation (EU) 2024/1689, the EU AI Act, is the world’s first comprehensive AI law, and it governs artificial intelligence across drug discovery, clinical trials, pharmacovigilance, manufacturing and diagnostics. It sorts every system by risk, sets a full set of duties for the high-risk tier where most life sciences AI lands, and works alongside the MDR, the IVDR, GxP and the GDPR. From August 2026, those obligations apply across the European Union, and compliance is mandatory. Non-compliance can bring fines up to €35 million or 7% of global turnover, refused CE marking and product withdrawal. This two-hour online training turns every article into one clear method to apply, from first risk classification to post-market monitoring.

Across ten lessons, this certified course covers every part of the Act with real case studies, from scope and the risk-based 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.

What you’ll learn

• Classify any AI system into the correct risk tier and confirm whether it is high-risk under Article 6
• Apply the seven core requirements for high-risk AI under Articles 9 to 15
• Map the duties of providers, deployers, importers and distributors across the value chain
• Align the Act with the MDR, IVDR, GxP and data integrity expectations in pharma and devices
• Build a conformity file that proves compliance for EU inspections and audits

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