New Artificial Intelligence Law Comes Into Force Today, August 1, 2024: Key Points and Focus on High-Risk Devices

The European Parliament and the Council of the European Union have approved Regulation (EU) 2024/1689, establishing a uniform legal framework for the development, commercialization, and use of artificial intelligence (AI) systems across the European Union. The primary aim of this regulation is to promote human-centric AI, ensuring safety, health protection, and fundamental rights while fostering innovation and competitiveness within the internal market.

Specific Requirements for Medical Devices with AI

Conformity Assessment: Before a medical device with AI can be marketed in the EU, it must undergo a rigorous conformity assessment process. This includes extensive testing to ensure the system is safe and complies with all applicable legal requirements.

Transparency and Explainability: Developers of these devices must ensure that the AI-generated outcomes are explainable and understandable to healthcare professionals, facilitating informed decision-making.

Continuous Monitoring: Once the device is in use, continuous monitoring is required to detect and mitigate any risks that may arise during its operation, ensuring the device’s safety and effectiveness over time.

Data Protection: Medical devices with AI must adhere to strict data protection standards, ensuring the privacy and security of patient information.

This regulation marks a milestone in the regulation of artificial intelligence in Europe, aiming to balance citizen protection with the promotion of technological innovation in key sectors such as healthcare.

If you believe your product needs to comply with the new EU regulations, CMC can provide you with the guidance needed to ensure your products can be safely marketed in Europe.