Medical Devices: Reviewing Regulatory Changes in the US and EU- Broadcast #1

The Medical Device Regulation (MDR) and In-vitro Medical Device Regulation (IVDR) came into effect in Q2 of 2017.  The transition period will be 3 years for the MDR and five years for the IVDR, meaning that the dates of application will be Q2 2020 and Q2 2022 respectively. We have 3 (or 5) years, so we don’t have to do anything immediately right?  Wrong! There are some pretty major changes so it is essential that medical device manufacturers get management engaged in the process now so that money and resource can be available to support and implement the new regulations.

In the United States, MDUFA and other regulations updated in 2017, have an immediate impact on how medical device manufacturers are developing and marketing their products. There are steps medical device manufacturers can take to comply with all regulations and help ensure successful clinical trial execution.

Join Angela Stokes who will discuss the funding, people and steps to be taken now to ensure the major aspects of the new regulations are known, and plans are put in place to deal with modifications in classification, format of technical files, conformity assessment routes and other changes to ensure an uninterrupted supply of medical devices in the marketplace.  Eric Distad will share his extensive experience in navigating US and global regulations on medical device development and offer insight into best practices for medical device clinical development in this era of increased regulatory review.

Broadcast #2 is identical for this webinar recording

Speakers

Angela Stokes, Senior Director, Regulatory Consulting, Syneos Health

Angela Stokes has worked in Regulatory Affairs for more than 25 years, in large and small pharmaceutical and device companies and in CROs and specialist Regulatory affairs consultancies.  Currently Angela is Senior Director of Global Regulatory Consulting at Syneos Health. She has extensive speaking and chairing experience at conferences and on MSc and other courses spanning 20 years – speaks on all aspects of regulatory affairs including medical devices, biotechnology Japan and clinical trials.

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Eric Distad, Executive Director, Clinical Development, Medical Device and Diagnostics, Syneos Health

Mr. Distad has more than 23 years of experience in all facets of clinical research including 21 years in medical device clinical research.  He has experience at one of the top-three medical devices companies as well as having experience in the start-up atmosphere.  Mr. Distad has been responsible for the development and management of more than forty (40) IDE studies including protocol development through final report/submission to regulatory authorities.  His experience includes primarily Class III devices with indications in neurology , cardiac, vascular, diagnostic including complex companion diagnostics, combination products, and orthopedics.  Geographically, Mr. Distad has significant experience managing trials in the United States, Canada, Europe, and Hong Kong/China including extended assignments

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