The Impact of the AI Act on Medical Devices: Regulatory and Toxicological Considerations
The integration of artificial intelligence (AI) into medical devices is rapidly transforming the healthcare sector.
While these technologies offer new opportunities for diagnosis, monitoring and clinical decision-making support, they also raise new challenges regarding safety, quality and regulatory compliance.
With the introduction of the AI Act (Regulation (EU) 2024/1689), manufacturers of certain medical devices incorporating AI must now consider an additional regulatory framework alongside the Medical Device Regulation (MDR) 2017/745 and, for in vitro diagnostic medical devices, the IVDR 2017/746.
1. Stricter requirements for AI-enabled medical devices
The AI Act introduces specific requirements for AI systems classified as high-risk. For certain medical devices, these requirements interact with the existing requirements established under the MDR or IVDR.
A. Data quality and governance
Article 10 of the AI Act places particular emphasis on the data used to train, validate and test AI systems.
Manufacturers must ensure, among other things, the relevance, quality and representativeness of the datasets used, while considering potential biases that could affect the safety or health of individuals. For medical devices, data quality therefore becomes an important element in demonstrating safety and performance.
B. Technical documentation and traceability
High-risk AI systems are also subject to enhanced requirements regarding technical documentation, record-keeping and traceability. The objective is to demonstrate compliance, support an understanding of the system’s functioning and ensure appropriate monitoring throughout its lifecycle.
2. AI Act and MDR: two regulatory frameworks to consider together
One of the main challenges for manufacturers is understanding how the different regulatory requirements interact.
The MDR continues to establish requirements for the safety and performance of medical devices, while the AI Act introduces specific requirements relating to AI systems.
The European Commission published MDCG 2025-6 in June 2025, specifically addressing the interplay between the MDR, IVDR and AI Act. This guidance is particularly relevant for manufacturers developing medical devices that incorporate AI technologies.
The regulatory approach must therefore be considered from the earliest stages of device development.
3. The role of standards in compliance
Manufacturers can also rely on standards and frameworks to structure their AI development and management processes.
ISO/IEC 42001:2023, which addresses artificial intelligence management systems, can help organizations establish a structured approach to AI governance.
However, it is important to distinguish between regulatory requirements and voluntary standards: certification to ISO/IEC 42001 does not, by itself, demonstrate compliance with the AI Act.
4. A toxicologist's perspective
From the perspective of a toxicologist specialized in regulatory compliance, the integration of AI into medical devices introduces an additional dimension to safety assessment.
The performance of an algorithm cannot be considered independently from the quality of the data used, its intended purpose, its limitations and the potential consequences of an incorrect output.
The approach should therefore remain based on a structured risk assessment, taking into account both the requirements of the MDR or IVDR and those of the AI Act where applicable.
For manufacturers, the challenge is not simply to comply with an additional regulation. It is to be able to demonstrate, through documented and traceable evidence, that the device remains safe and performs as intended throughout its lifecycle.
At Toxi Plan, this regulatory and risk-based approach supports manufacturers in their safety and compliance assessments for medical devices incorporating emerging technologies.
Our conclusion – Understanding leads to better security
As AI continues to transform medical devices, regulatory compliance must evolve alongside technological innovation. A risk-based approach is essential to ensure safety, performance and traceability throughout the device lifecycle. At Toxi Plan, we help manufacturers navigate these evolving regulatory and toxicological requirements with confidence.
Disclaimer:
The information provided in this article is for informational and educational purposes only. It does not constitute legal advice nor a personalized regulatory consultation. Despite the care taken in drafting this article and verifying its sources, regulations evolve regularly and may be subject to differing interpretations depending on the specific context of each company, product, or market.
Toxi Plan®, its directors, and its employees shall not be held liable for any use made of the information contained in this article without further analysis tailored to a specific situation. Any regulatory or strategic decision should be based on a specific assessment carried out by a qualified professional, with due regard to the applicable regulations, including any provisions or regulatory practices entering into force after the date of publication.