Medical Devices
News
news
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Team-NB 2025 Sector Survey: Growth Slowdown and Workforce Pressures Among Notified Bodies
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The European Association of Notified Bodies for Medical Devices, Team-NB, has released the results of its annual survey covering the 2025 activity of its 41 designated members.
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Europe finally gets its own Breakthrough program for medical devices
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The EMA launches a pilot inspired by the American model to accelerate access to innovative technologies. A long-overdue catch-up or a risky bet?
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Embecta Acquires Owen Mumford in £150M Deal, Betting Big on the Future of Drug Delivery
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Embecta Corp. has closed its acquisition of UK-based Owen Mumford Holdings Limited for up to £150 million, bringing aboard the next-generation Aidaptus® auto-injector platform. The deal reshapes embecta’s future as a broad-based medical supplies company serving patients across diabetes, obesity, autoimmune diseases, and anaphylaxis.
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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.
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Notified body under pressure to deliver Medical Devices CE Marking
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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, improving the market access timeline for medical devices. Adopted on 4 May 2026 by the European Commission, Implementing Regulation (EU) 2026/977…