LNE G MED CE Marking IVD Medical Devices 0001IVDs (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…

 

DOWNLOAD THE GUIDE

Events

Find an answer to the challenges you are facing in one of our upcoming events: trainings, webinars, forums...

Learn more