IVDR Certified! KBMED Strengthens Its Position in the European Blood Collection Market

KB Medical Group proudly announces that its blood collection tubes have successfully transitioned from the EU In Vitro Diagnostic Medical Devices Directive (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (IVDR), making it one of the first suppliers to achieve this certification. This major milestone will significantly enhance KBMED’s ability to expand its market presence in Europe and meet growing demand. 🏅  

Stricter Regulatory Requirements:

The European Union introduced IVDR (Regulation (EU) 2017/746) on May 5, 2017, officially replacing IVDD on May 26, 2022. IVDR establishes rigorous regulatory requirements for in vitro diagnostic medical devices to ensure product safety and performance. The regulation imposes higher standards, including stricter clinical evidence, more frequent evaluations, and enhanced transparency than the directive.