September 29, 2025

Team-NB: “1st EU Regulations Discussion Day”.

[2025-09-19] (Open access) Team-NB (The European Association of Medical devices Notified Bodies) announces its 1st EU Regulations Discussion Day 2025. This event is aimed at small and medium-sized enterprises (SMEs), members of notified bodies and organizations. It aims to encourage exchanges between stakeholders on the future European regulatory framework for

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Swissmedic: instructions for use in electronic form

[2025-08-08] On August 8, 2025, Swissmedic, the Swiss Agency for Therapeutic Products, immediately adopted the new European Union (EU) requirements for the electronic availability of instructions for use for medical devices. Context As a reminder, the new Implementing Regulation (EU) 2025/1234, amending Implementing Regulation (EU) 2021/2226, was adopted on June

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