The Software as a Medical Device (SaMD) Working Group has invited stakeholders to review and comment on the draft document titled ‘Essential Principles and Content of Predetermined Change Control Plans.’ The consultation aims to collect insights and finalize the document’s content before its official publication. The feedback period concludes on 8 December 2025, presenting a significant opportunity for clinical, quality, and regulatory teams to shape the future guidelines for changes in SaMD products.
What changed?
The SaMD Working Group has drafted new guidance to streamline how manufacturers document and manage anticipated changes within Software as a Medical Device. Called the ‘Essential Principles and Content of Predetermined Change Control Plans’, this draft proposal directly addresses how manufacturers outline strategies for implementing predictable and controlled updates to their products without compromising safety or performance. The document is positioned to align with international regulatory trends.
Who is affected?
This consultation is relevant to various stakeholders in the medical device industry, particularly:
- Developers and manufacturers of Software as a Medical Device.
- Regulatory professionals involved in premarket submissions for SaMD products.
- Clinical and quality assurance teams managing risk and compliance frameworks.
- Regulatory bodies and consultants seeking alignment on global standards.
The insights provided by these groups will be crucial in ensuring the final document meets its objectives effectively.
Key details of the consultation
The consultation period began in November 2025 and will run until 8 December 2025. The primary objective is to refine the draft and collect industry-wide feedback to enhance the utility and applicability of the guidance. The draft encompasses essential components such as:
- Criteria for determining when changes require premarket review.
- Standard practices for risk management and its integration into change control plans.
- Alignment with existing regulatory requirements and industry best practices.
Stakeholders are encouraged to review the full document and provide detailed comments on any ambiguities or potential challenges it may pose for implementation.
How to provide feedback
Interested parties can access the draft guidance and details on how to submit feedback by visiting the official consultation webpage linked below. Participants are urged to ensure their comments are evidence-based, concise, and actionable. Detailed examples, especially related to practical applications, are welcomed to provide the most value to the review process.
This initiative represents a significant step in advancing regulatory practices surrounding SaMD products, promoting patient safety while facilitating innovation.
Frequently Asked Questions
1. What is Software as a Medical Device (SaMD)?
SaMD refers to software intended for medical purposes, such as diagnosing, preventing, or treating health conditions, without being part of a hardware medical device.
2. Why was this consultation launched?
The consultation aims to refine industry and regulatory alignment on managing predictable changes to SaMD through predetermined change control plans.
3. How can I access the draft document?
The draft document is available on the consultation webpage linked at the end of this article.
Conclusion
The SaMD Working Group’s draft consultation represents a pivotal opportunity for stakeholders to influence the guidance shaping how predictable changes are managed in Software as a Medical Device. Manufacturers, quality assurance teams, and regulators alike are encouraged to engage fully, ensuring the final document meets the sector’s needs while preserving global alignment in safety and performance standards.
Disclaimer
This announcement is intended for informational purposes only and does not constitute legal advice. For regulatory guidance, consult your legal or compliance team.
Mandatory Information
For full information about the announcement, see the link below.
https://www.imdrf.org/news-events/software-medical-device-consultation-closing-8-december-2025