EU MDR – Preparing for Disruptive (yet Incomplete) Regulation

Minnie Baylor-Henry, J.D., YourEncore
Jon Lange, EY

The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.

But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?

In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.

About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.

About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead.  He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.