IVDR implementation for clinical laboratories – Current state of play
The in-vitro diagnostics regulation (IVDR) will soon replace the current in-vitro diagnostics directive (IVDD) across the EU. The regulations have a broader scope than the previous laws and specifically include software and novel technologies such as genetic testing as well as devices manufactured and used within health institutions. In addition, they introduce a new, risk-based classification system for IVDs. How are Clinical MS users affected?