The July Issue of EU MDR & IVDR Insider Is Here
Fresh insights and resources for Medical Device and IVD Manufacturers
This issue covers strategic guidance on global audit alignment through MDSAP, with a special focus on Software as Medical Device (SaMD) and the evolving harmonization landscape.
👉 Download the Full PDF issue
What’s Inside This Edition:
Update: Welcome to the July Issue
Dr. Akra highlights new MDCG guidance (2025-5) on performance studies under IVDR, including ethics requirements, study modifications, and data traceability expectations. He also flags regulatory developments in Switzerland, the UK, and the rollout of ISO 10993-1:2025 and UDI deadlines for vision-related devices.
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Upcoming Webinar
Designing for Safety: How Quality, Risk, and Patient Impact Interconnect
August 19, 2025 – 4 PM CET / 10 AM ET
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Andrew Gibson, PhD, Senior Managing Consultant and Team Leader, AKRA TEAM
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Arie Henkin, Chief Clinical Officer, Omniscient Neurotechnology (o8t)
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Notified Body Speaker (TBA)
👉 Register now
Inside MDSAP: 3 Key Takeaways
Based on insights from AKRA TEAM’s June webinar, this edition explores the promise, challenges, and next steps for global audit alignment under MDSAP.
- The Single Audit Dream: MDSAP’s Original Vision vs. Reality
MDSAP was designed to reduce regulatory burden by consolidating audits across the U.S., Canada, Brazil, Japan, and Australia.
While it delivered efficiency, full regulatory harmonization remains elusive. The article traces the history from GHTF to IMDRF, examining implementation trade-offs and the associated jurisdictional complexity
👉 Read the article - Software as a Medical Device: The MDSAP Adaptation Challenge
Modern software-based devices—such as AI, cloud platforms, and machine learning tools—strain traditional audit models.
This article discusses the challenges faced by current frameworks in supporting continuous development, cloud deployment, and algorithm versioning. It calls for evolving audit processes and auditor capabilities to address cybersecurity, data governance, and real-world performance monitoring
👉 Read the article - The Harmonization Dream Deferred
MDSAP made audits easier, but regulatory differences persist.
The third article analyzes why full regulatory harmonization remains a long-term goal—and what steps the IMDRF and regulators must take to move beyond audit efficiency. It outlines challenges (sovereignty, legal frameworks, and market protection) and opportunities through pilot programs, observer expansion, and AI-driven convergence.
👉 Read the article
MDSAP Nonconformity Management & Reporting (Decision Tree)
Actionable Resources for MDSAP Compliance
Check out our visual MDSAP Nonconformity Management & Reporting Decision Tree to streamline CAPA processes and improve audit outcomes.
Webinar Replay
Navigating Multi-Regulatory Harmonization Under MDSAP
Recorded on June 26, 2025, featuring Sean Gibbons (Philips), Matteo D’Angelo (TÜV SÜD), and Lawrence Yeh (AKRA TEAM)
Replay this webinar on MDSAP implementation, cross-jurisdictional audits, and emerging trends. Includes full transcript and slide deck.
👉 Watch Now | View Slides | Read Transcript
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