A practical, plain-language course for Regulatory Affairs and Quality Managers who want to stop shipping paper Instructions for Use. You'll learn the exact legal basis — Commission Implementing Regulation (EU) 2021/2226, consolidated with the (EU) 2025/1234 amendment — which devices qualify, what the Article 4 risk assessment must cover, what your eIFU website and service must deliver, and a step-by-step roadmap from paper to electronic. Told along the story of Sabine, an RA manager on a mission to retire her company's infamous paper IFU ("The Brick") — with fun facts that are real, legal facts that sound made up, and a happy ending involving a picture frame.
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