Recentes

• Submission of vigilance reports to Notified Bodies under EU MDR & IVDR
• FUTURE GOVERNANCE OF MEDICAL TECHNOLOGIES IN EUROPA. Joint discussion paper .
• Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028
• MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
• 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