RAPS Vancouver Chapter: Webcast Breakfast Series: Understand the New EU Medical Device and IVD Regul

Starts:  Jun 14, 2017 10:00 (ET)
Ends:  Jul 11, 2017 12:00 (ET)

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:

  • Wednesday, 14 June – Background to New EU Regulations
  • Wednesday, 21 June – EU MDR Requirements
  • Wednesday, 5 July – EU IVDR Requirements
  • Tuesday, 11 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 have been published. This webcast series draws together industry experts and leading Notified Bodies who have been closely following the evolution of the new regulations, developing positions on what will be required 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).