ELITechGroup obtains new IVDR certificate for PCR assays

  • 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.

Latest news


ELITechGroup Launches Second IVDR Certified Gastrointestinal Infection Assay: GI Parasitic PLUS ELITe MGB® Kit 

ELITechGroup launches their second kit of the Gastrointestinal infection assay panel targeting parasitic pathogens.  The ELITe MGB Gastrointestinal assays are IVDR-certified in combination with InGenius and BeGenius, fully automated samples-to-results instruments.  The company will shortly launch two more gastrointestinal assay infection panels targeting viral pathogens and Norovirus.   ELITechGroup announces the…

ELITechGroup launches CE-IVDR certified GI Bacterial PLUS ELITe MGB® Kit and expands in vitro diagnostic portfolio

ELITechGroup launches their first kit of the Gastrointestinal assay panel targeting bacterial pathogens. ELITechGroup is planning to launch three additional kits covering the full range of gastrointestinal infections within the next quarter. In a significant move towards advancing global diagnostic capabilities, ELITechGroup proudly announces the introduction of the GI Bacterial…

Let us help you

For general inquiries, please use the links to the right. The Contact link leads to a brief online form, and the Support link offers general phone and email information. Someone will be in touch with you soon.