Archives: EU

Subscribe to EU RSS Feed

EU Agrees on New Medical Device and IVD Regulation

An article authored by Healthcare principal John Wyand and associate Sarah Stec published in the November/December edition of the Food Drug Law Institute’s Update Magazine, looks at the impact of the EU’s regulations governing medical devices and in vitro diagnostic medical devices. The regulations seek to fill the regulatory gaps uncovered as technology evolved faster … Continue Reading

BREAKING: Deal Reached on New EU Medical Device and IVD Regulations

On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations.  The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had … Continue Reading
LexBlog