The Medical Devices Introductory Course 2020

Structure of the Legislation and Key Content Define the requirements and the process of ‘ CE marking ’

Define the ‘ Essential Requirements ’ / ‘General Safety & Performance Requirements’ for quality, safety and performance that all devices must meet before being placed on the market

Provide risk-based classification for medical devices

Outline routes for manufacturers to demonstrate compliance for each classification of medical device: Conformity Assessment Procedures

The Organisation for Professionals in Regulatory Affairs

The CE Mark

"Conformité Européene"

Devices … must bear the CE Marking of Conformity when they are placed on the (European Union) Market

The Organisation for Professionals in Regulatory Affairs