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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- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
- Total Product Lifecycle Considerations for Generative AIEnabled Devices
- MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)
- Team-NB High level position on the regulatory framework for the medical devices sector
- CONTROLO DE ALTERAÇÕES : Sessão esclarecedora com uma discussão bastante interessante sobre o assunto
- EU Prosperity and Competitiveness: Recommendations for implementing the EU Green Deal in Healthcare