OCT Medical Devices 2025: European AI Act Compliance
The European Union’s AI Act is poised to shape the future of medical devices, particularly those that incorporate artificial intelligence (AI). For healthcare firms involved in software-as-a-medical-device (SaMD) or digital and AI devices, compliance with this regulation should not be viewed as a cause for panic.
Understanding the AI Act
The AI Act was passed by the European Parliament on March 13, 2024, received approval from the EU Council on May 21, 2024, and officially entered into force on August 1, 2024. It serves as a risk-management system aimed at identifying, evaluating, and mitigating the potential risks that AI systems may pose to health, safety, and fundamental rights such as privacy and data protection.
For those with Class IIa or higher AI-related devices, compliance with the AI Act is expected to mirror the requirements of the EU Medical Device Regulation (MDR). This familiarity is crucial for companies already engaged in MDR compliance efforts.
Key Compliance Dates
While various deadlines for compliance exist, the vast majority of medical devices falling under the Act’s Annex I product safety component must be compliant by August 2, 2027. This timeline provides a clear pathway for organizations to prepare for compliance.
Integrating AI Act with MDR
The AI Act is described as an “interesting type of Act” that blends product legislation with human rights-adjacent legislation. It is designed to work in conjunction with the MDR to ensure rights, fairness, and respect for human rights. New transparency requirements under the AI Act relate to safety and fairness—elements that were already present in the MDR.
Compliance Strategies
Companies already preparing AI-based software for the MDR should find that their compliance processes remain largely consistent, albeit with increased emphasis on data transparency. It is advised that organizations prepare early for new standards and guidance, integrating these into their quality management processes as they become available.
Conclusion
As the landscape of medical devices continues to evolve with advancements in AI, understanding and adhering to the AI Act will be essential for compliance. The regulation aims to ensure safety while fostering innovation in the medical device sector. Organizations should view this as an evolution of their existing compliance frameworks rather than a complete overhaul.
