Understanding the In Vitro Diagnostic Regulation (IVDR)
In Vitro Diagnostic Regulation (IVDR) EU 2017/746 took full effect, replacing the previous Directive, IVDD 98/79/EC. This new regulation significantly […]
Medical device regulation EU
Approaching IVDR Compliance: Key Considerations for In Vitro Diagnostic Devices
With the European Union’s In Vitro Diagnostic Regulation (IVDR) deadline quickly approaching, it is crucial for manufacturers to understand the