New EU MDR/IVDR Authorized Representative guidance summary
For manufacturers who are not established in the European Union, t...
Trend reporting in IVDR context and Requirements
Manufacturers of devices, made available on the Union market, othe...
IVDR: Latest plan of action from MDCG
Set A – Essential Actions No.TopicActionTimelineStatus 1Contingenc...
Clinical data for MDR/IVDR make it easy with real world
We all know that EU MDR and IVDR are clinical data hungry. When th...
IVD Clinical Performance Studies for FDA & EU
At present, the regulatory discussion pretty much focuses on MDR R...
IVDR requirements for SOFTWARE
Software fulfilling the definition of an in vitro diagnostic medic...
