The Medical Devices Introductory Course 2020

POLL QUESTION

Q: Is it necessary for a Class I (non-measuring, non-sterile, non-reusable surgical instrument) device manufacturer to have a Quality System? Answer: Yes or No

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

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)

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs