The EU in vitro diagnostic medical device regulatory landscape is changing drastically. The changes of the IVD Medical Device Directive 98/79/EC (IVDD) are expecting to lead to a fully remodeled regulation impacting:
•Clinical evidence requirements
•New technical specifications, etc....
For information on the new requirements so far and the changes that could be coming, manufacturers can tune to LNE/G-MED North America's upcoming Free webinar, Evolutions in the EU IVD Regulatory Framework, on April 16th at 2:00 PM Eastern.
This webinar covers the major changes that we see coming in the new IVD regulatory framework, as well as a notified body's perspective on what these changes mean for an IVD manufacturer.