Please join regulatory professionals in your region for the first Regulatory Affairs Professionals Society (RAPS) Roadshow in Europe. This event will feature RAPS’ executive director Paul Brooks, a recognized expert on medical device regulations. His presentation will address the key changes introduced by the new European Medical Device Regulation (MDR) including the expanded scope of the regulation, and changes in classification and conformity assessment. Brooks also will discuss RAPS' current initiatives and commitment to serving the European regulatory community.
The new regulation will impact every medical device manufacturer’s systems, processes, resources and timelines for approvals. Transition from the current Medical Device Directive (MDD) to the new MDR is expected to begin in the summer of 2017 and to be in full force in 2020. Although three years seems to be a reasonable transition period, the challenges and practicalities of the new regulations facing manufacturers, Notified Bodies and other stakeholders are significant. There is no time to lose in preparing for and demonstrating compliance with the new regulations, to allow legacy and new devices to achieve CE marking and continued access to the European market.
This meeting is sponsored by the new RAPS Europe Regional Chapter and is hosted by SciPro. It is intended to advance knowledge and facilitate networking among regulatory professionals. SciPro will host a networking reception with light refreshments after the presentations.