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.
News & Trends
Procurar
Recentes
- Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply Decision Guide Flowchart
- New Qualification & Validation Guidelines for Pharma in 2025
- ENISA Cybersecurity Maturity & Criticality Assessment of NIS2 sectors
- EMA FAQs How to submit an annual safety report and respond to related RFIs
- Questions and answers on the Critical Medicines Act
- Atualização das listas previstas no regulamento sobre o controlo de transações de medicamentos para o exterior do país (março 2025)
- Factsheet – Critical Medicines Act: Improving the availability and securing supply of critical medicines in the EU
- Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (March 2024, Revised February 2025);