Blogs

Introduction: Understanding the New IVDR Regulation The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) has replaced the older In Vitro Diagnostic Directive (IVDD) (98/79/EC), introducing stricter regulatory requirements for in vitro diagnostic (IVD) medical devices...

The In Vitro Diagnostic (IVD) industry is witnessing transformative regulatory changes across global markets. As we step into 2025, medical device companies, laboratories, and manufacturers must stay ahead of compliance updates in the European Union...

Introduction In the ever-evolving world of medical technology, innovation is key to improving patient outcomes and healthcare efficiency. However, proving that a new medical device is superior to an existing one requires rigorous scientific validation....