Regulating AI under the EU MDR - Ensuring Compliance and Innovation

Interested participants from other time zones are welcome to contact us regarding the training at [email protected].

As artificial intelligence transforms healthcare, medical device manufacturers face unprecedented regulatory challenges. The convergence of the EU Medical Device Regulation (MDR) and emerging AI legislation creates a complex compliance landscape that demands specialized expertise. 

With this rapid advancement of AI technologies and the increasing role of software in healthcare, understanding the regulatory requirements for AI based Medical Device has become crucial for ensuring compliance, safety, and effective performance. As AI technologies increasingly influence healthcare, from diagnostic tools and decision support systems to patient monitoring and robot-assisted surgeries, regulatory frameworks must evolve to ensure these devices are safe, effective, and ethically responsible. While the EU MDR focuses on the safety and performance of medical devices, the EU AI Act introduces a legal framework that targets AI-specific risks, such as fairness, transparency, accountability, and trustworthiness. Manufacturers must now navigate a dual regulatory environment to ensure compliance, safety, and ethical responsibility. 

Given that AI often involve complex algorithms, continuous learning, and large datasets, traditional regulatory approaches may not always be sufficient to address these new technologies' challenges. The EU MDR will continue to serve as the core framework for ensuring medical device safety, but the EU AI Act will add complementary requirements for AI systems that go beyond traditional medical device regulations. These two sets of regulations combined create a complex but essential framework for ensuring AI based Medical Devices are safe, effective and ethically compliant. 

A well-rounded understanding of these requirements is not only essential for obtaining and maintaining CE marking but also for ensuring patient safety, fostering innovation, and mitigating risks associated with the increasing use of AI in healthcare. 

Core Topics Covered in the Training:

• Introduction into EU AI Act (Regulation (EU) 2024/1689)
• Overview AI Act incl. its objectives and its approach
• Terms & definitions incl. examples related to medical devices
• Scope of EU AI Act
• Timeline for implementation 
• Relevance of EU AI Act for Medical Devices
• Introduction of MDCG 2025-6 Interplay between MDR and AIA
• Classification of medical devices according to the AI Act
• Product related requirements for high-risk AI based Medical Devices incl. overview of requirements for technical file
• Requirements for AI Economic Operators incl. overview of requirements for Quality management system and its processes incl. introduction into DIN EN 18286:2025 

Target Audience: Regulatory Affairs Managers, Medical Device Manufacturers, Clinical Evaluation Experts, Quality Assurance Managers and Consultants focused on AI-driven healthcare technologies, AI developers, anyone involved in bringing AI-enabled medical devices to the European market. 

Benefit:

• Gain in-depth understanding of the EU AI Act and its impact on regulating AI-based Medical Devices.
• Understand the requirements of EU AI Act for AI-based Medical Devices and learn approaches how to meet the most relevant ones.
• Understand the requirements of EU AI Act for Quality Management Systems for manufacturers of AI-based Medical Devices and learn approaches how to meet the most relevant ones. 

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.