The EU Regulation on Medical Devices 2017/745 (MDR) significantly changed the landscape for the medical device industry. The Regulation introduced 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. The Regulation also introduced a responsible person for regulatory compliance for manufacturers and additional duties for importers and distributors.
The MDR set requirements for consultation procedures and scrutiny for high-risk devices. As the transition is coming to an end now is the right moment to get insights on how to deal with the requirements, understand how to prepare for the end of transition period and discuss latest updates and practical solutions.
The seminar allows participants to get a clear picture on the Regulation, understand transition timelines and ensure compliance to the new landscape.
The seminar includes knowledge transfers, interactive sessions, case studies and practical hints helpful for MDR implementation.