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The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group has published the draft Essential Principles and Content of Predetermined Change Control Plans document for public consultation.
The document is intended to support the development of PCCP frameworks that may allow regulatory oversight to keep step with the rapid pace of software development practices. The framework is broad but harmonised and is intended to allow jurisdictions to tailor the proposed concepts to suit their unique regulatory environments.
Stakeholders are invited to review the draft document and provide feedback prior to the consultation’s closure on 8 December 2025.
Feedback can be submitted via the IMDRF Consultation Hub on Citizen Space: IMDRF Consultation Feedback - Essential Principles and Content of PCCP (N90 - SaMD WG) - Medical devices - Citizen Space