Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.
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- Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
- AI Omnibus enters into force
- EU CTR Q&A Version 7.3 is Out
- New WHO guide on Artificial intelligence-related health research
- GDP for APIs: APIC Publishes Updated “How to Do” Document
- Team-NB Position Paper :TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES
- MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- New ISO Guidance for AI-Powered Medical Devices: ISO/TS 24971-2:2026 Published!