Are you interested in the new European Medical Device and In Vitro Diagnostic regulations, but missed RAPS Virtual Program? The RAPS Vancouver Chapter invites you to join others from your local regulatory community to view the recorded webcasts over breakfast, followed by interactive discussion about the new requirements and the impact on legacy devices. Coffee and pastries will be provided and attendees may claim two RAC recertification credits per session. Registration is available for each session individually, or for the entire series.
There will be four morning sessions with a new 90-minute webcast shown at each meeting:
Tuesday, 13 June – Background to New EU Regulations
Tuesday, 20 June – EU MDR Requirements
Tuesday 27 June – EU IVDR Requirements
Tuesday 4, July – Technical Documentation, Postmarket and Other
The European Commission published proposals for new regulations of medical devices and in vitro diagnostics in 2012. Now, after years of negotiation within the EU legislative system and with interested stakeholders, the new regulations are expected to be published in 2017. This webcast series draws together industry experts and leading Notified Bodies who have been closely following the evolution of the proposed regulations, anticipating the final texts, developing positions on what will be required by the regulations, and understanding the impact on manufacturers, devices and systems both new and legacy.
Each session provides different perspectives/opinions from different Notified Bodies and experts on the key significant changes that will impact all medical devices and in vitro diagnostics being placed into Europe under the new European Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). This program will also consider the impact on legacy devices cleared, CE marked, and under the existing EU Medical Device Directive (MDD) and In Vitro Diagnostics Directive (IVDD).