An 8-Step Comprehensive Guide to EU IVDR Compliance
In vitro diagnostics (IVDs) are devices used to perform tests outside the human body on samples, such as blood, urine, or tissue. They are used to detect diseases, monitor health, and guide treatment decisions. They play a crucial role in healthcare by enabling early...
How to Make Your Legacy Devices IVDR Compliant? 8-Step Guide
Legacy IVD devices are IVDs legally CE-marked under the old EU In Vitro Diagnostic Directive (IVDD). They were CE marked before the EU In Vitro Diagnostic Regulation (IVDR) took effect. They are allowed to remain in the market during a defined transition period if...
Mandatory EUDAMED implementation from 28 May 2026: How must EU medical device and IVD manufacturers prepare?
European database on medical devices (EUDAMED) is the digital backbone for regulatory oversight across the EU medical device and IVD ecosystem. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED will be...