The AI Act (2024/1689) is  the EU’s first regulation on artificial intelligence, which entered into force in August 2024.

AI is defined as” a machine-based system that  can  operate with varying levels of  autonomy,  exhibit adaptiveness after deployment, and generate outputs (such as predictions, decisions, or recommendations) that can  influence real or virtual environments”.

 As artificial intelligence (AI ) technologies increasingly influence healthcare, from diagnostic tools and decision support systems to patient monitoring , regulatory frameworks must evolve to ensure that AI enabled medical devices and Software as medical devices(SaMDs)  are safe, effective, and ethically responsible.

 While the EU MDR ( EU MDR 2017/745 ) focuses on the safety and performance of medical devices, the EU AI Act ( the AI Act 2024/1689)  introduces a legal framework that targets AI-specific risks ( e.g  algorithm drift, dataset drift, cybersecurity) vulnerabilities , model degradation over time) and requires a risk management system that operates throughout the AI system lifecycle.

Thus,  AI-enabled medical devices, and software as a medical devices (SaMDs) must comply with the EU Medical Device Regulation (MDR 2017/745), the EU Artificial Intelligence Act (AI Act-2024/1689), and the General Data Protection Regulation (GDPR) to obtain CE Marking and operate legally in the EU market. The convergence of the EU Medical Device Regulation (MDR), AI Act and GDPR creates a complex compliance landscape that demands specialized expertise. 

 Tox Regulatory Advisor is here to  simplify the process and support with full compliance:

• Impact assessment: Qualification and classification of the devices as well as identifying conformity assessments 
• Gap analysis:  Compare your EU MDR/IVDR documentation and process against AI Act
• Regulatory Strategy Development:  provide tailored compliance plans
• Technical Documentation & QMS Updates: Ensuring full alignment and integration with EU MDR/IVDR & AI Act
• AI Risk Management & Data Governance:Implementing AI-specific safeguards.
• Support you through the CE Marking process.