TestLine Clinical Diagnostics Embraces IVDR Certification Journey
A Step Forward in
Compliance with IVDR Regulation
TestLine
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
diagnostics.
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.