- After the release of the first IVDR certificate at the beginning of the year ELITech Group continues to expand its portfolio of IVDR-certified PCR assays to support European diagnostic laboratories.
- The company is fully committed to delivering its entire portfolio of nearly 60 molecular assays as IVDR compliant by 2026
Torino (Italy), 9th October 2023 – ELITechGroup, a leader in molecular diagnostics, announces the addition of new IVDR-certified PCR kits to its ever-growing portfolio.
The In Vitro Diagnostic Medical Devices Regulation (IVDR) came into force on May 26, 2022, raising the standard of diagnostic assays after the introduction of the In Vitro Diagnostics Directive (IVDD) in 1998. The new regulation applies to all manufacturers of in-vitro-diagnostic devices and is intended to ensure greater compliance, increased patient safety as well as testing efficiency.
In January 2023, ELITechGroup received its first IVDR certificate for class C antibiotic resistance testing. Today, the company added class B infectious disease tests such as Bordetella and gastrointestinal assays to its IVDR portfolio.
The achievement of the second IVDR milestone is a further demonstration of ELITechGroup’s commitment to supporting clinical laboratories worldwide with state-of-the-art assays. The company is on track to the full and timely transition from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the end of 2026.
About ELITech Group
ELITech Group is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.
ELITech Molecular Diagnostics (MDx), one of the four business units of ELITech Group, serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.