Adapting your business: are you ready for the new EU regulations? (pdf)
After many years, discussions on the medical device and IVD regulations are potentially coming to an end. The current ‘trilogue’ discussions between the European Council, Parliament and Commission could see a final new set of Regulations as early as spring / summer 2016.
Recognised from the outset by MedTech Europe and member companies as a “Business issue, not just a regulatory issue” this session will explore the degree of readiness of companies including ‘best-in-class’ examples of being prepared and the impact on strat-plans and portfolios.
In this session EY will give an overview of the current state of play, after which a panel discussion will commence with various experts on the topic including a representative of the European Notified Bodies.