The Medical Devices Introductory Course 2020

Location of device information in CTD for medicinal product with integral device?

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

Day 1 Refresh ... Classification

 First determine – do you need one? Do you have a medical device?

 Classify your medical device

• Decide on the “conformity assessment” route • Implement quality management system; contract with NB (if needed) • Conduct and document testing and development; demonstrate compliance with the “Essential Requirements” • Sign a Declaration of Conformity • Attach the CE Mark, register and launch • … But, don’t forget … post-market compliance

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs