October 24, 2017

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.