The EU Regulation on Medical Devices 2017/745 (MDR) changes significantly the landscape for the medical device industry. Beyond the familiar framework of the Medical Devices Directive 93/42 based on general requirements for safety and performance, harmonized standards, risk classification, the new Regulation introduce novel requirements in key areas such as stronger Notified Body Oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements and Post Market Surveillance as well as labelling requirements. The Regulation also introduces a new responsible person for regulatory compliance (PPRC) for manufacturers and additional duties for importers and distributors. The Regulation further brings new evaluation procedures for high-risk devices and scrutiny of conformity assessments.
This online training gives Industry a detailed understanding of the new requirements and insight into how to prepare the end of the transition period in May 2021. With this course, participants will get a clear picture of the new requirements, understand the transition timelines and insure compliance to the new landscape.