TestLine Clinical Diagnostics Embraces IVDR Certification Journey
A Step Forward in Compliance with IVDR Regulation
Clinical Diagnostics has achieved a significant milestone on its path to In
Vitro Diagnostic Regulation (IVDR) certification. Following a successful EU
Quality Management System Audit conducted by 3EC International a.s., NB 2265, a
recognized notified body, we are proud to announce our compliance with the new
IVDR. This certification applies to our latest TestLine Clinical Diagnostics
products, introducing cutting-edge technologies to the field of serological
In addition to our IVDR class A self-certified products, we are excited to bring six new products under IVDR class C. These innovative offerings further expand our portfolio and demonstrate our dedication to meeting the highest regulatory standards.
Our CLIA immunoassays offer a versatile, fast, intuitive, and innovative solution for efficient diagnostics. Additionally, our Microblot-Arrays (MBA) enable highly sensitive quantitative analysis of biological samples, providing a high-throughput alternative to ELISA-based testing.
The IVDR is a mandatory requirement for manufacturers of in vitro diagnostic devices. It ensures that declarations of conformity are issued, products are CE marked, and recertification is obtained in alignment with the new regulation.
Seamless Transition from IVDD to IVDR
TestLine Clinical Diagnostics is committed to a smooth and timely transition from the In Vitro Diagnostics Directive (IVDD) to the IVDR. We assure our customers of uninterrupted access to our portfolio of CE-IVD marked products, as well as our dedication to ongoing innovations.
As of May 26, 2022, the requirements of the IVDR regulation came into effect. CE-marked devices from TestLine Clinical Diagnostics, which were lawfully placed on the market in accordance with IVDD (Directive 98/79/EC) prior to the application date, can continue to be made available until specific dates depending on their IVDR risk class. These dates are May 26, 2025, May 26, 2026, or May 26, 2027.
At TestLine Clinical Diagnostics, we embrace this transition as an opportunity to enhance our commitment to delivering high-quality diagnostic solutions while ensuring compliance with the latest regulatory standards.