The EU's AI Act: What It Means for the Medical Device Industry
The European Union's AI Act (2024/1689) marks a significant shift in the regulation of artificial intelligence within the medical device industry. Published in the EU's "Official Journal" on July 12, 2024, the Act entered into force on August 1, 2024.
This landmark legislation introduces a comprehensive regulatory framework designed to manage the risks associated with AI systems, categorizing them into four risk levels: minimal, limited, high and unacceptable.
For the medical device industry, this Act is particularly impactful. AI systems classified above Class I (under the Medical Device Regulation, MDR) or Class A (under the In Vitro Diagnostic Regulation, IVDR) are considered high-risk AI Systems under the AI Act. This classification comes with several stringent requirements that manufacturers must navigate, which may already be familiar under the existing MDR and IVDR frameworks.
Navigating High-Risk AI Systems in Medical Devices
The AI Act sets forth specific obligations for high-risk AI systems, many of which align closely with the conformity assessment procedures already in place under MDR and IVDR. However, the integration of these requirements introduces a complex regulatory landscape for manufacturers of AI-based medical devices. One of the key provisions of the AI Act allows Notified Bodies—organizations designated to assess the conformity of medical devices—to conduct combined assessments under both MDR/IVDR and the AI Act. However, this is contingent upon these bodies being evaluated and recognized as compliant with the AI Act during the MDR/IVDR notification process. Currently, the precise requirements for this combined assessment process have yet to be defined.
Key Dates and Milestones
The AI Act introduces a phased approach to implementation, with various provisions coming into force over the next few years. Here's a breakdown of the critical implementation dates:
| Date | Obligation |
| 2nd August 2024 | AI act enters into force |
| 2nd February 2025 | Chapter I: Prohibitions on AI practices Chapter II: General provisions |
| 2nd August 2025 | Chapter III Section 4: Notifying authorities and Notified Bodies Chapter V: Obligations for providers of general-purpose AI models Chapter VII: Governance structure (including AI Office, AI Board, etc.) Chapter XII: Penalties provisions (except fines for providers of GPAI) Article 78: Confidentiality obligations |
| 2nd August 2026 | Main provisions of the regulation become applicable |
| 2nd August 2027 | Article 6 (1) and obligations: Obligations related to high-risk AI systems that are safety components or components of products covered by Union harmonization legislation |
Frequently Asked Questions (FAQ)
Can I apply for a conformity assessment for my AI medical device under the AI Act now?
Will DEKRA Certification B.V. also become a Notified Body for AI Act to enable combined assessments with MDR/ IVDR?
What You Can Do Now to Prepare
1. Stay Informed: Keep up with updates on the AI Act as more details become available. They will help you anticipate the specific requirements your AI systems will need to meet.
2. Assess the requirements: Start by reviewing the AI Act to understand its potential impact on your AI-based medical device.
3. Strengthen MDR/IVDR Compliance: Since the AI Act will align closely with MDR and IVDR, ensure that your current AI medical devices are fully compliant with these existing regulations. This will make it easier to transition to the AI Act's requirements when they become applicable.
4. Develop a Compliance Strategy: Begin drafting a compliance strategy that considers both current MDR/IVDR requirements and anticipated AI Act obligations. While specific actions will depend on the final rules, having a flexible plan in place will put you in a stronger position when the time comes.
Conclusion
The EU's AI Act introduces new layers of complexity for the medical device industry, particularly for those involved in the development and deployment of high-risk AI systems. While the Act aligns closely with existing regulations, the need for combined conformity assessments under both the MDR/IVDR and the AI Act presents both challenges and opportunities. Manufacturers should stay informed about the evolving regulatory landscape to ensure compliance and leverage the benefits of these new frameworks.