Episode 032: Navigating the New EU Medical Device Regulations

New regulations, which were adopted on May 26, 2017, will affect all device and diagnostics manufacturers looking to sell products in the EU, with stricter requirements being introduced in order for these products to be approved.  We are just over a year out from implementation of some of these European Union Medical Device Regulations (EUMDR), set for May 2020.  With the deadline looming, how prepared should manufacturers be at this point – and how prepared are they?

Adam Steadman, Vice President, Clinical Development, Medical Devices & Diagnostics at Syneos Health, discusses the importance of these regulatory changes, highlights some of the key steps manufacturers need to take and examines the challenges inherent in gathering the data required for re-certification and ultimately, renewed market approval, in the EU.

If you want to see more on this topic, check out our white paper and webinar.

Like what you hear?  Please be sure to subscribe, rate and review us!

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.