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Implementing Regulation (EU) 2026/977 sets enforceable deadlines on Notified Bodies to deliver CE Marking decisions
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Published in the Official Journal of the EU on 5 May 2026, this regulation sets for the first time uniform quality management and procedural requirements applicable to notified bodies under the MDR and IVDR. Adopted on 4 May 2026 by the European Commission, Implementing Regulation (EU) 2026/977 aims to correct the divergent practices observed across…
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Medtech : Avoid the Tech Startup Trap!
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The tech startup model, centered on speed and iteration, collides with the realities of the MedTech sector, where compliance, traceability, and clinical validation are prerequisites for market access. Transposing these methods without adaptation leads to blockages, high remediation costs, and a loss of credibility.