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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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