AI Act and Medical Devices

Medical devices must meet strict requirements regarding safety and clinical effectiveness. A systematic assessment of risks and benefits is required throughout the entire life cycle of a device.

Clinical investigations and post-market feedback play a key role in the assessment of safety, as defined within the European Union by Regulation (EU) 2017/745 (MDR), with the aim of ensuring higher standards of safety and performance. With technological advancements, artificial intelligence is increasingly becoming an integral part of medical devices.

In June 2024, a new Regulation (EU) 2024/1689, the so-called AI Act, was adopted. It entered into force on August 1, 2024. Certain provisions, such as definitions and prohibited practices, began to apply on February 2, 2025. EU Member States must implement the AI Act into their national legislation by August 2, 2025, with full application starting on August 2, 2026.

The AI Act classifies products based on their risk level. Medical devices incorporating artificial intelligence fall under the high-risk category. Manufacturers are required to ensure that AI systems are transparent and that their outputs are based on verifiable and reproducible methods.

On the other hand, notified bodies must assess the reliability and safety of the AI, including the evaluation of algorithms, data sets, and the impact on clinical outcomes.

This requires the involvement of experts with appropriate competencies in both medical devices and artificial intelligence. These experts must operate independently from manufacturers and other industry stakeholders and must actively prevent potential conflicts of interest. Notified bodies are under continuous supervision by competent regulatory authorities, who verify their compliance with the requirements of applicable regulations, relevant guidelines, and standards.

The medical device industry is facing increasingly strict regulatory requirements, aimed at promoting higher levels of safety and quality. The integration of artificial intelligence in medical devices increases the need for transparency and safety of algorithms. Companies must actively monitor regulatory changes, work closely with notified bodies, and implement appropriate procedures to ensure compliance.

Key recommendations include proactive certification, documentation digitalization, and the establishment of robust post-market surveillance systems. Timely adaptation will allow companies to maintain competitiveness and ensure smooth access to the European market.