The Medical Devices Introductory Course 2020

Summary of Key Steps to the CE Mark  Define Intended Purpose of the device *  Classify device *  Choose a Conformity Assessment Procedure & Establish Quality Management System (if not already in place) and contract a NB, if required *  Conduct and document testing and development; demonstrate compliance with the “Essential Requirements”/ “GSPRs”  Conduct Risk Assessment(s) *  Collect and Prepare Technical Documentation *  Submit to NB, if required  Sign the Declaration of Conformity  “Affix” the CE Mark and place on the EU/EEA market  Launch and Register the Product (Competent Authority Notification) Risk Management * throughout * In conjunction and in parallel with device design and development plan (include regulatory affairs as part of the design and development plan)

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

Case Study

The Organisation for Professionals in Regulatory Affairs