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Introduction
Changes to CE Certification Process
Regulation Classification
Economic Operators
Eudamed
Labeling with CE Symbol
Certification Process
Class I - Self Declaration
CE Requiring Notified Bodies
Technical Documentation
Annex I - GSPRs
Annex II - Format and Content of Technical File
Annex III - Post-Market Surveillance Documentation
Annex IV - Declaration of Conformity
Clinical Evaluation Report (CER)
Risk Management File
Comparison with Regulatory Process in Other Countries
Timeline for CE Marking
Recap
CE Marking is the most rigorous approval process in the world
PiP Scandal
Metal-on-Metal (MoM) Implant Recalls
Plan and Prepare for CE Marking
Thank you