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.
Learning objectives:
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
Presentation and Discussion will be led by a panel of experts:
Anchal Choudhuri
Vice President, Medical Devices & Combination Products
United States
Jan Bart Hak
Managing Consultant & Head Medical Device Department
The Netherlands