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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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Namix RA syringe recall escalate to Class I after FDA Intervention.
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Medline Industries recalled all lots of its Namic Rotating Adaptor (RA) syringes after identifying that the rotating adaptor mechanism could unwind during an active vascular procedure, risking blood loss, infection, and potentially fatal air embolism. The US regulator subsequently classify the event as a major recall.