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...
Medical Devices – USA/Europe Regulatory Updates Roundup, Apr 2022
EUROPE (EU) | USA (FDA) | ROW – BRAZIL (ANVISA)
EUROPE (EU) ...
IVDR: Latest plan of action from MDCG
Set A – Essential Actions No.TopicActionTimelineStatus 1Contingenc...
Is your Diagnostic State-of-Art?
Are you sure from IVDR perspective?
You being “SURE”, or your comp...
IVD Clinical Performance Studies for FDA & EU
At present, the regulatory discussion pretty much focuses on MDR R...
