The Medical Devices Introductory Course 2020

The RouteToThe CE Mark Medical Device?

 First determine – do you need one? • Do you have a medical device? • What is a Medical Device?  Medical Device Directive – Definition … • 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

The Medical Device Regulation – Definition of a Medical Device

“Medical Device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes : ...

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs