Overview
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
Introduction
The International Medical Device Regulators Forum (IMDRF) has released new guidance documents aimed at improving the regulation of medical device software (MDSW). These documents provide crucial recommendations for manufacturers and regulatory bodies to ensure the safety, effectiveness, and compliance of software-based medical devices. The guidance reflects the increasing reliance on software in modern healthcare and the need for a harmonized regulatory approach across global markets.
Importance of the IMDRF Guidance
With the rapid advancements in digital health technologies, the role of software in medical devices has expanded significantly. Medical device software, whether embedded in hardware or standalone, plays a vital role in patient care and diagnosis. The IMDRF guidance offers clarity on regulatory expectations, promoting innovation while maintaining patient safety. By aligning international regulations, the documents help streamline approvals and market entry for software-based medical devices.
Key Aspects of the New Guidance Documents
Software as a Medical Device (SaMD) Classification – The guidance provides a structured approach for categorizing software based on its intended use and level of risk.
Cybersecurity Considerations – Manufacturers must implement robust security measures to protect patient data and prevent cyber threats.
Lifecycle Management – The documents outline best practices for maintaining software throughout its lifecycle, including updates, patches, and post-market surveillance.
Artificial Intelligence and Machine Learning (AI/ML) in MDSW – Specific recommendations address the unique challenges posed by AI-driven medical device software, ensuring transparency and reliability.
Characterization Considerations for Medical Device Software and Software-Specific Risk
Expanding on the risk categorization framework established in IMDRF/SaMD WG/N12 FINAL:2014, the newly introduced N81 document reflects the evolving landscape of medical device software. Recognizing the varied interpretations of software regulations across different jurisdictions, this guidance aligns with the terminology in the EU MDR/IVDR by adopting the term medical device software (MDSW). Notably, the scope of N81 has been broadened to include embedded software—Software in a Medical Device (SiMD)—a crucial addition. However, it is important to emphasize that N81 serves as a complementary framework rather than a replacement for N12. The document provides critical insights into effectively characterizing MDSW and assessing software-specific risks, ensuring a more consistent and structured regulatory approach.
Medical device software is changing fast
Medical Device Software, particularly AI/ML Enabled devices are evolving rapidly. In the medical device industry, international collaboration and global harmonization are essential to reducing regulatory fragmentation, ensuring consistency in MDSW regulation, and streamlining market entry. These two IMDRF documents are welcome additions to the goal of fostering international harmonization and will play a crucial role in the marketing strategy of manufacturers seeking multi-market access for such devices.
Impact on the Medical Device Industry
The release of these guidance documents is expected to have a significant impact on medical device software manufacturers, regulators, and healthcare providers. By adopting a standardized approach, companies can reduce compliance burdens and accelerate market access. Moreover, the focus on cybersecurity and AI-driven technologies highlights the growing emphasis on digital health innovation.
Conclusion
The IMDRF’s new guidance documents mark a pivotal step toward the harmonization of medical device software regulations. By addressing classification, cybersecurity, lifecycle management, and AI considerations, these documents provide essential insights for stakeholders navigating the evolving landscape of digital health. As software continues to revolutionize healthcare, adherence to these guidelines will be crucial in ensuring safe and effective medical technologies for patients worldwide.
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References
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