The New Medical Device Regulation – How to Hit the 2020 Deadline (pdf)
Studio 4 (2nd floor)
The New Medical Device Regulation contains significantly more detail than the current Directives. Over 300 pages in draft form, and containing in excess of 50 delegated and implementing acts, how the needed secondary legislation and guidance is both prioritised and developed will fundamentally determine how effectively and smoothly both the regulators and the regulated industry can transition to the new Regulation. This session aims to demystify the Regulation and give insights into the path forward, allowing businesses to plan for the impacts and the uncertainties ahead.