Where Medical Device Regulation is Headed – Taking the Mystery out of Changes in the EU and US

Exciting things are happening in the world of medical device development and one of the big areas of discussion is regulatory-related changes. On May 26, 2021, the Medical Device Regulation (MDR) takes effect in the EU, resulting in many new regulatory requirements for medical device developers. Although there is not a complete overhaul in the regulatory framework in the US, there have also been a number of changes as of late that are critical for Sponsors to be aware of and plan for in order to obtain successful interactions with FDA. In our next Insider Talks our experts will dive into what these changes are and how to adapt appropriately to ensure the success of your medical device.

Interested in learning more? Register today and join us for a live webinar!

Learning objectives of this Complimentary Live Webinar:

· What will the new requirements look like in the EU and how should Sponsors adapt their regulatory strategy appropriately to obtain marketing approval for their device?

· Explain the recent changes to FDA’s 510(k) pathway and how this will impact Sponsors

· Overview of FDA’s newer programs such as those for breakthrough devices or devices that are considered safer than those on the market in the United States

About Insider Talks

Insider Talks is an open forum where our industry experts share their insights on timely topics. Pharmaceutical, biotechnology and medical device companies gain new ideas and perspectives to help tackle complex challenges and deliver on our higher purpose of improving the health and safety of patients.