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EU AI Act 2024: Complete Guide for Life Sciences

The European Union’s Artificial Intelligence Act represents the world’s first comprehensive legal framework for AI. For life sciences companies, understanding and preparing for these requirements is essential.

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Overview

The EU AI Act, officially adopted in 2024, establishes a risk-based approach to AI regulation. Medical devices and healthcare applications fall under high-risk categories, requiring stringent compliance measures.
The AI Act will be phased in over 24-36 months, with some provisions taking effect as early as Q3 2024.

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Key Requirements for Life Sciences

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High-Risk AI Systems

AI systems used in medical devices and healthcare diagnostics are classified as high-risk and must comply with:
  • Data Governance: Implement robust data quality and management practices
  • Technical Documentation: Maintain comprehensive records of AI system design and training
  • Transparency: Provide clear information about AI capabilities and limitations
  • Human Oversight: Ensure appropriate human supervision of AI decisions
  • Accuracy & Robustness: Demonstrate consistent performance across diverse populations

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Quality Management Systems

Companies must establish quality management systems that include: 
1. Risk management procedures
2. Post-market monitoring plans
3. Incident reporting mechanisms
4. Regular conformity assessments
5. Continuous improvement processes

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Impact Timeline

PhaseDateRequirements
Phase 1Aug 2024Prohibited AI practices banned
Phase 2May 2025General-purpose AI obligations
Phase 3Aug 2026High-risk system requirements
Phase 4Aug 2027Full implementation

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Preparing for Compliance

1

Assess Your AI Systems

Inventory all AI systems and classify them according to risk levels
2

Gap Analysis

Compare current practices against AI Act requirements
3

Implementation Plan

Develop a roadmap for achieving compliance
4

Documentation

Create and maintain required technical documentation
5

Training

Educate teams on AI Act requirements and procedures

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Comeply’s AI Act Solution

Streamline AI Act Compliance

Learn how Comeply automates AI Act documentation and compliance management.

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Additional Resources

This article is for informational purposes only and does not constitute legal advice. Consult with qualified legal counsel for specific compliance questions.