The rise of SaMD represents a significant opportunity to revolutionize healthcare. However, navigating the regulatory requirements of the EU MDR can be a challenge for manufacturers of medical devices. With stringent demands for risk management, clinical evaluation, and post-market surveillance, compliance can seem overwhelming.

This presentation will provide an exploration of the MDR requirements specific to SaMD and with that, the challenges manufacturers face. Through real-world examples and actionable best practices, we will discuss strategies to simplify compliance, including:

• Determining the appropriate software classification
• Embedding MDR requirements early in the development process
• Conducting clinical evaluations to demonstrate safety and performance
• Managing continuous software updates while maintaining compliance
• Addressing cybersecurity concerns

By aligning with MDR requirements, SaMD manufacturers not only meet regulatory requirements but also establish trust with their end-users, enhance product quality, and support the advancement of sustainable e-health solutions. This presentation will empower participants with practical insights to tackle compliance challenges and will provide information on how to navigate MDR so that it becomes an enabler for delivering safe and effective devices, rather than a barrier.