CE MARKING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES 

Get your FREE Guide 

IVDs (in vitro diagnostic devices) play an important role in the diagnosis and treatment of diseases around the world, including Europe.  As with medical devices, the regulations for marketing IVDs in the European Union requires that the manufacturer follow a conformity assessment route to show that their IVD conforms to essential requirements.  However, because of the inherent differences between medical devices that fall under the MDD and IVDs, they have their own essential requirements and different classification rules and common technical specifications.  

LNE/G-MED, as a Notified Body notified to the IVD Directive, wrote this IVD Guide for IVD manufacturers seeking to market their products in Europe.  As a companion to its widely popular CE Marking Guide, this IVD Guide outlines the process for CE Marking IVDs in the European Union.  It includes insights into the Directive that only a Notified Body can give, including the process that IVD manufacturers would follow for CE Marking their IVD with LNE/G-MED.  

Download this IVD Guide today and start your IVD’s regulatory approval process for Europe!