RAPS event: The Impact of the EU MDR Regulation on Legacy Devices
November 7 - 8, 2018 - Amsterdam MD USRAPS
nsankey@raps.org
Phone:301 770 2920
The new European Union (EU) Medical Device Regulation (MDR) significantly changes the regulatory framework for placing any new medical device on the market, but it does not provide any specific instruction for applying the new requirements to legacy devices with valid certifications under the Medical Device Directive (MDD). Legacy devices can no longer be “grandfathered” into compliance and the implications are significant, from updating technical documentation, to changing product labels and demonstrating robust clinical evidence. If your company markets medical devices in the EU and has legacy products on the market, it is vital to have a transition plan in place for compliance with these new requirements before the 2020 deadline. This two-day interactive workshop, hosted by RAPS, is aimed at mid-level regulatory professionals who are responsible for applying the EU MDR requirements to his/her organisation’s products. Providing a better understanding of the impact of the changes on legacy products and direct access to experts in this area, the workshop will enable attendees to leave with a clearer path for creating their transition plan. Note: Each participant must bring their own laptop to contribute to the whitepaper discussions. RAPS does not supply computer equipment for attendees.