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:

•IVD classification
•Conformity assessments
•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.


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