The European Union In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) introduces updated requirements for the safety, performance, and lifecycle management of in vitro diagnostic (IVD) products placed on the EU market.
In response to this regulatory transition, JASEM is actively preparing to align its IVD product portfolio and related processes with the IVDR requirements. Accordingly, the company is reviewing and structuring its activities across the product lifecycle, including design and development, manufacturing, quality management, technical documentation, performance evaluation, and post-market surveillance.
JASEM remains committed to regulatory readiness and continuous improvement, with the objective of supporting a smooth transition to IVDR and ensuring long-term compliance with applicable European regulatory standards.