Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026 скачать в хорошем качестве

Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026

Harmonized standards are supposed to make compliance easier—yet under MDR/IVDR, many manufacturers are still navigating uncertainty: delayed harmonization, shifting expectations from notified bodies, and the practical question of what to do when “the right standard” isn’t harmonized (or isn’t updated yet). In this Friday In-Focus session, Beat Keller (Managing Director, SMDC Swiss Medical Device Consulting) breaks down what harmonized standards really mean in Europe, how they connect to presumption of conformity, and how manufacturers should think about standards strategy going into 2026—especially when the standards landscape is still evolving. What you’ll learn: • What “harmonized” actually means (and what it does not guarantee) • How harmonized standards support presumption of conformity under MDR/IVDR • Why Europe’s harmonization process creates real-world gaps for manufacturers • What to do when standards aren’t harmonized or updated (documented justification strategies) • How notified bodies typically assess standards use in technical documentation • Practical actions to de-risk 2026: standards mapping, gap assessments, and evidence planning Timestamps 00:00 – Welcome & why harmonized standards matter in 2026 02:10 – What “harmonized standard” means in the EU system 05:05 – Presumption of conformity: what it gives you (and what it doesn’t) 08:40 – MDR/IVDR reality: delays, gaps, and moving targets 12:15 – How notified bodies look at standards during reviews 16:30 – When a standard isn’t harmonized: acceptable alternatives & justification 21:05 – State of the art: how to support your rationale 26:10 – Standards mapping: linking GSPRs to standards and evidence 31:45 – Common pitfalls (and how to avoid audit findings) 38:20 – Building a 2026 action plan: prioritization & documentation strategy 45:10 – Q&A and practical scenarios from manufacturers 52:30 – Wrap-up & key takeaways About Friday In-Focus Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers. 👉 Join the MLVx community: https://members.mlvexchange.com 🎟️ Use code SEAN20 to save 20% on membership.