Team-NB Publishes Official Position on the Application of the AI Act to Artificial Intelligence Medical Devices
Team-NB - the European Association of Notified Bodies for Medical Devices - has published its official position on the application of the European Artificial Intelligence Regulation (Regulation (EU) 2024/1689) in the medical devices with AI (MDAI) sector. The document, dated April 2025, offers a detailed analysis of the main challenges and practical aspects of implementing the AI Act, especially with regard to its articulation with the MDR and IVDR.
Key dates to remember
August 1, 2024: Entry into force of the AI Act
August 2, 2025: Member States must have designated competent authorities for the designation of Notified Bodies under the AI Act
August 2, 2027: Mandatory application of the AI Act to high-risk AI systems, including medical devices that integrate AI or function as such
Main points of Team-NB's position
1. Medical devices with AI are considered high risk
Devices that include or consist of AI systems are classified as high risk when they require third-party conformity assessment under the MDR or IVDR. These devices will have to cumulatively comply with the requirements of the AI Act and specific medical device legislation.
2. Risks of a lack of designated Notified Bodies
Team-NB warns that delays in national legislation and in the process of designating notified bodies could jeopardize the implementation of the AI Act in 2027, creating bottlenecks in the certification of AI technologies.
3. Integration of conformity assessment processes
Compliance will be assessed according to the processes established by the MDR/IVDR (Art. 43(3)), with specific additions from the AI Act. The aim is to avoid duplication of audits and simplify the regulatory process for manufacturers.
4. Additional requirements of the AI Act
The AI Act introduces complementary obligations in areas such as:
Protection of fundamental rights (e.g. privacy, non-discrimination)
Transparency and human supervision of AI systems
Risk management and data traceability
Access to training, validation and testing data sets by NOs
Possibility of access to source code in justified cases
5. Critical definitions need more clarity
Terms such as "AI system", "safety component" and "substantial modification" are considered decisive for the scope and impact of the regulation, and Team-NB advocates that they be the subject of harmonized practical guidelines.
6. Monitoring and interoperability of reporting systems
It is necessary to ensure integration or interoperability between the AI Act security reporting platforms and the systems already in use at the MDR/IVDR, to avoid duplication of administrative efforts and ensure efficient surveillance.
Data Management: a Regulatory Challenge
The quality, representativeness and documentation of the data sets used in AI systems will be central to compliance. Team-NB points out that there is still no clear path to access to independent, high-quality data for NBs, which could make it difficult to certify AI devices.
Implications for Manufacturers
Manufacturers of software as a medical device (SaMD), as well as medical devices with AI components, must:
Review your product life cycle management strategies;
Adapt their quality management systems to the combined requirements of the MDR/IVDR and AI Act;
Anticipate reinforced audits and increased documentary requirements;
Guarantee the traceability and governance of the data used in its algorithms;
Monitor the process of designating Notified Bodies for AI in their countries.
How Smart MDR can support
Smart MDR closely follows the evolution of European artificial intelligence regulations and provides comprehensive support to medical device and IVD manufacturers:
Assessing the impact of the AI Act on your product portfolio
Adaptation of technical and software documentation
Interface with Notified Bodies and support for audits
Talk to us to ensure that your AI-powered device meets all regulatory requirements before 2027.
Be Smart. Be Compliant.
