The June Issue of EU MDR & IVDR Insider Is Here
Fresh insights and resources for Medical Device and IVD manufacturers
This issue covers essential guidance on mastering medical literature review with a focus on notified bodies, R&D, and systems that scale.
What’s Inside This Edition:
Update: Welcome to the June Issue
By Bassil Akra, PhD
Dr. Akra shares recent developments, including insights from MDCG documents on the EU AI Act and Medical Device Software (MDSW) apps, as well as a recent position paper.
3 Key Takeaways: Medical Literature Review
Based on insights shared on a recent AKRA TEAM webinar, we share three new articles:
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What Notified Bodies Really Look For In Literature Reviews breaks down how notified bodies evaluate literature reviews in MDR submissions, focusing on methodology, synthesis, and clinical relevance. It outlines common pitfalls—like lack of critical appraisal or poor search logic—and provides practical tips to strengthen clinical evaluations.
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Why Literature Reviews Should Start In R&D, Not Regulatory reframes literature reviews as strategic tools best initiated in R&D—not just compliance steps late in development. It outlines how early evidence analysis informs design, mitigates regulatory risk, and reduces costly clinical studies down the line.
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How to Build Literature Review Systems That Scale lays out how standardized templates, digital tools, and AI-powered workflows can turn literature reviews into scalable, audit-ready systems. It’s a practical guide to shifting from one-off compliance exercises to efficient, portfolio-wide strategies that save time, cut costs, and boost regulatory confidence.
Flowchart and Tips
Actionable Resources on Literature Review
Get 13 expert tips and a visual flowchart to streamline MDR literature reviews—optimize searches, use AI tools, and boost quality from start to finish.
Webinar Recording
Mastering Literature Review for Medical Devices: From Compliance to Strategic Insight
Did you check out the webinar featuring Dimitriya Bozukova, Diane Legere, Romney Adams, and Ulla Gertig?
Access the full recording, transcript, and slides for expert insights on streamlining scientific reviews with confidence throughout the product lifecycle.
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