Leveraging MDSAP to Strengthen MDR Quality Management and Audit Readiness
A new regulatory affairs review examines how the Medical Device Single Audit Program can help structure quality management, internal audits and conformity control under Regulation (EU) 2017/745, particularly for French medical device manufacturers.
The review highlights that MDSAP and the EU MDR are distinct frameworks, but structurally related through their shared reliance on ISO 13485:2016 as a core quality management reference.
MDSAP and MDR: Distinct but Structurally Connected
The document explains that MDSAP is a voluntary, multi-jurisdictional audit programme built on ISO 13485:2016 and covering Australia, Brazil, Canada, Japan and the United States.
By contrast, the MDR is a binding EU regulation combining QMS oversight with product-level conformity assessment through Notified Bodies and competent authorities.
The review makes clear that MDSAP is not recognised for CE marking and cannot substitute for MDR conformity assessment. However, its process-based audit methodology can support manufacturers in building a more mature and audit-ready QMS.
Current MDSAP Audit Approach and ISO 13485 Alignment
The review discusses the updated MDSAP Audit Approach, including MDSAP AU P0002.011, published on 3 August 2026.
According to the document, the recent revisions have anchored MDSAP more tightly to ISO 13485, especially following the FDA’s transition to the Quality Management System Regulation, which incorporates ISO 13485:2016 into 21 CFR Part 820.
This convergence strengthens the practical value of an MDSAP-aligned QMS for manufacturers operating across EU and international markets.
Benefits for MDR Audit Readiness
The document identifies several transferable benefits of the MDSAP methodology for MDR readiness.
These include a more robust and systemic QMS, stronger documentary discipline, better control of supplier management, post-market surveillance, design control and risk management, and improved preparation for demanding MDR audits.
The review also notes that adopting MDSAP audit discipline internally can support earlier detection of QMS weaknesses, better anticipation of Notified Body findings and a more effective continuous improvement process.
Product-Level Evidence and Technical Documentation
Although MDSAP is formally focused on the QMS, the review clarifies that MDSAP audits may include sampled review of product-level evidence.
This may cover design verification and validation, risk control effectiveness, clinical or performance evaluation and technical documentation currency. Such evidence can support a manufacturer’s preparation for MDR technical documentation review, but it does not replace the Notified Body’s legally binding assessment under MDR Annexes II and III.
The document’s comparative table also reinforces this distinction: MDSAP provides a QMS audit with sampled product documentation review, while the MDR requires full technical documentation review and binding conformity assessment for CE marking.
Regulatory Gaps to Manage
The review emphasises that manufacturers must actively manage the differences between the two frameworks.
Key gaps include:
no mutual recognition between MDSAP and MDR;
different geographic scope;
MDR-specific technical and clinical requirements;
EU-specific PMS, PMCF, PSUR and EUDAMED deliverables;
Notified Body technical file review;
MDR unannounced audits and product testing;
EU-specific requirements across MDR Annexes I to XVII.
The document also notes that EN ISO 13485:2016/A11:2021 provides an important bridge between ISO 13485 and MDR requirements, particularly through Annex ZA, which maps relevant ISO 13485 clauses to MDR QMS requirements.
MDSAP-Inspired Internal Audit Programme
The review proposes adapting the MDSAP audit sequence into an MDR-oriented internal audit programme.
The proposed structure covers seven processes:
Management;
Design and Development;
Production and Control;
Purchasing and Supplier Control;
Post-Market Surveillance;
Vigilance and CAPA;
Documentation and Traceability.
For each process, the review identifies corresponding MDR-specific evidence, such as PRRC designation, design history files, ISO 14971 risk files, clinical evaluation, PMCF plans, PSURs, FSCA records, EUDAMED submissions, UDI registration and technical documentation under MDR Annexes II and III.
Impact on Medical Device Manufacturers
For medical device manufacturers, especially those operating in both EU and non-EU markets, the review highlights the strategic value of using MDSAP as a methodological complement to MDR compliance.
Manufacturers should pay particular attention to:
ISO 13485-based QMS maturity;
process-based internal audits;
objective evidence and traceability;
supplier management;
design and development controls;
PMS, vigilance and CAPA effectiveness;
MDR technical documentation readiness;
clinical evaluation and PMCF evidence;
EU-specific gaps not covered by MDSAP;
Notified Body expectations for CE marking.
The key message is that MDSAP can strengthen quality culture, audit discipline and international readiness, but it must be used as a complement to MDR compliance — not as a shortcut or substitute for CE marking.
