Europe 2025 Agenda
Venue: Online Webinar
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Session 1: 24 April 2025​​
EU Medical Device Quality System Requirements
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Session 2: May 2025​​
Economic Operators Responsibility & Compliance (EU Rep, Manufacturer, Distributor)
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Session 3: June 2025​​
MDR compliant Technical File -> Technical Documentation & Standards requirements
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Session 4: July 2025
Biocompatibility Evaluation Process (MD)
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Session 5: August 2025
Clinical Investigation Study (MD)
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Session 6: September 2025
Clinical Performance Study (IVD)
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Session 7: October 2025
Clinical Evaluation Documentation (MD)
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Session 8: November 2025​​
Performance Evaluation Documentation (IVD)
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Session 9: December 2025​​
PMCF Planning & Post Market Data Reporting
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Session 10: January 2026​​
Labelling, UDI & EUDAMED
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