The landscape of artificial intelligence regulation has reached a pivotal moment. On 12 July 2024, the much-anticipated European Union (EU) AI Act, REGULATION (EU) 2024/1689, was officially published in the EU Official Journal. This landmark legislation will have a direct impact on all software regulated as medical products in Europe that incorporate AI, marking a significant shift in how AI technologies are governed in the healthcare sector.
As of today, we are on the countdown to the AI Act coming into force on 2 August 2024. This marks the beginning of a structured timeline for compliance that organizations must adhere to:
- 2 February 2025: Prohibited AI practices must be discontinued. This first milestone ensures that any AI applications deemed unethical or harmful are swiftly removed from use.
- 2 May 2025: Implementation of codes of practice. These codes will provide a framework for best practices and standards that AI technologies must follow, promoting transparency and accountability.
- 2 August 2025:
- General Purpose AI models must conform. This ensures that widely used AI models meet the new regulatory standards.
- The establishment of the AI Governance structure. This body will oversee the enforcement of the AI Act, ensuring compliance and addressing any issues that arise.
- 2 February 2026: The European Commission’s adoption of the Implementing Act for post-market monitoring. This step is crucial for continuous oversight and ensuring ongoing compliance with the regulation.
- 2 August 2026: Full application of the AI Act, inclusive of high-risk systems in Annex III. At this point, all high-risk AI systems must comply with the detailed requirements of the AI Act, ensuring safety and efficacy.
- 2 August 2027: High-risk systems in Annex I must meet all requirements. This final deadline ensures that the most critical AI systems are fully compliant with all regulatory standards.
This comprehensive legislative framework will apply to all AI-inclusive software regulated as medical devices in Europe. For those medical devices requiring a conformity assessment with a review by a notified body, the assessment will be twofold, ensuring compliance with both the AI Act and the respective Medical Device Regulation (EU) 2017/745 (MDR) or In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
If your medical devices incorporate AI, it’s crucial to understand these changes and prepare accordingly. We’re here to assist every step of the way. Adapting to these regulations will not only ensure compliance but also enhance the safety and effectiveness of AI-driven medical technologies.
For more information, you can access the full text of REGULATION (EU) 2024/1689 here.
For detailed insights or assistance with the new regulatory requirements, contact us at: [email protected]
