The planned deletion of Article 82 of the MDR could have far-reaching consequences for software and AI in drug trials. The more digital systems evaluate clinical endpoints or generate evidence, the more important the question becomes: is it an investigational device or an investigational product? It is precisely this distinction that could become the central regulatory challenge in the future.
The rapid advances in artificial intelligence and the entry into force of the DigiG are promoting the integration of intelligent medical devices into healthcare by making diagnostics, therapy and assistance systems more efficient and at the same time improving access and reimbursement of digital applications.
From theory to practice: effectively implementing the EU AI [...]
With the Cyber Resilience Act (CRA) and the upcoming AI Act, the EU is setting new requirements for IT security and the use of artificial intelligence (AI). These regulations play a central role, particularly in the area of digital healthcare products, which include connected medical devices. The new regulations set standards that require an integrated safety strategy in order to make innovations such as AI in medicine safe and compliant.
The European legal framework, including the Medical Device Regulation ("MDR") and the soon to come into force AI Regulation ("AI Regulation"), places strict requirements on the safety and performance of AI-based medical devices. The relationship between the Medical Device Regulation and the AI Regulation is characterized by supplementary certification requirements: While the MDR regulates the safety and performance of physical medical devices, the AI Regulation addresses specific risks and the data integrity of AI systems. Products that fall under both sets of regulations must meet the requirements of both regulations in order to be certified, which provides a double safety guarantee for both physical and software-related safety.
