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 seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime. The authors predicted that the regulations "will strengthen the rules for placing medical devices on the market, as well as tighten market surveillance and vigilance. The regulations establish requirements for quality management systems, clinical evaluations and gathering clinical data, with specific duties for all economic operators, including manufacturers and distributors."
The article reprint appears courtesy of FDLI .