The MDSAP version AU P0002.010 – MDSAP Audit Approach, dated February 6, 2026, introduces structural changes and regulatory updates for medical device stakeholders participating in the Medical Device Single Audit Program (MDSAP).
🔄 1. Merging the Audit Model and Process Companion documents
The most significant change in this version is the merger of the “Audit Model” and “Process Companion” documents into a single, more detailed and prescriptive document.
The purpose of this consolidation is:
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Provide a single framework for assessing compliance that applies to all audited processes.
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Clarify and standardize expectations for Auditing Organizations (AO), including a more detailed description of their tasks and links to regulatory requirements.
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Strengthen the implementation of the process-based approach, in accordance with ISO 13485:2016 and the requirements of the participating jurisdictions.
🧠 2. Strengthening the “risk-based” approach and changing terminology
A significant conceptual change involves **replacing the term “critical supplier” with a broader formulation focused on the suppliers to be considered in the audit, thereby further aligning MDSAP with the risk management approach required by ISO 13485.**
This development highlights:
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a more comprehensive inclusion of external suppliers within the scope of the audit,
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greater focus on evaluating subcontracting processes and their potential impact on product compliance.
The goal is to ensure that supplier control and monitoring activities are consistent, well-documented, and reflect the level of risk associated with the audited products and processes.
🌍 3. Updating regulatory references by jurisdiction
The update to the Audit Approach is accompanied by a review of the regulatory references for several participating authorities, to ensure consistency with the regulations in effect in each region covered by the MDSAP.
🇦🇺 Australia
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The URPTG (Unified Regulatory Policy Task Group) has now been replaced by the PRAC (a new regulatory reference body).
🇧🇷 Brazil
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Updated ANVISA references:
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RDC 830/2023
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RDC 751/2022
These resolutions replace previous texts on Good Manufacturing Practices and are part of the compliance requirements.
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🇺🇸 United States (FDA)
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Removal of historical references to the Quality System Regulation (QSR), following the entry into force of the Quality Management System Regulation (QMSR) on February 2, 2026.
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The document also provides details on the requirements related to “Device Listing” and mentions PCCPs (Predetermined Change Control Plans) in the context of FDA audits.
These changes reflect the ongoing alignment of MDSAP with national regulatory frameworks, while enhancing the relevance of audits based on current requirements.
📈 Conclusion
The publication of Version 2026 of the MDSAP Audit Approach (MDSAP AU P0002.010) represents a significant step toward the harmonization of quality audit practices at the international level. It marks a shift toward a more structured, prescriptive, and risk-based approach, while taking into account regulatory developments in the major markets covered by the MDSAP program.