NEW YORK ─ Siemens Healthineers said Tuesday that the TÜV Rheinland certification agency has certified its first products under the new European In Vitro Diagnostic Regulation.
The Erlangen, Germany-based company said that TÜV Rheinland, a notified regulatory body, has certified its first 129 in vitro diagnostic tests for hemostasis and nephelometry. The tests were prioritized in accordance with IVDR classifications because they serve to diagnose and monitor the treatment of critical diseases, Siemens Healthineers said.
It added that TÜV Rheinland has also issued declarations of conformity for some of its less critical diagnostic products.
The IVDR calls for additional performance assessments over and above its predecessor directive, based on scientific, clinical, and analytical data. Its requirements were adopted by the European Parliament in 2017.
From May 2022, in vitro diagnostics sold in the European Union are required to be certified by notified bodies. A transitional regulation allows established, non-IVDR-certified products to be sold and used if they were launched in the EU before May 2022.
Siemens Healthineers said it is steadily implementing the requirements and preparing by May 2022 to have more than 4,000 products certified for laboratory, molecular, and point-of-care diagnostic testing.
"The entire industry had to set new priorities, such as bringing COVID-19 tests to market in record time and overcoming constraints in the global supply chain," Kerstin Wagner, head of marketing for laboratory diagnostics at Siemens Healthineers, said in a statement. "These challenges have made the implementation of the IVDR more difficult, but have not delayed it so far."
Though the EU has designated four standards organizations to clear diagnostic products in line with the IVDR, most experts agree that notified bodies do not have the capacity to assess all the IVDs that are currently on the market.