In the fall of 2024, altona Diagnostics received the certificate for compliance with all applicable requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR; EU 2017/746) for their PCR testing products. We can now launch CE-IVD marked products under the IVDR. The first assay to be launched will be the AltoStar® Parvovirus B19 PCR Kit 1.5 in January 2025, followed by a large set of AltoStar® assay products in the spring of 2025.
Regulation (EU) 2017/746, also known as the In Vitro Diagnostic Medical Devices Regulation (IVDR), is a European Union regulation aimed at ensuring the safety, quality, and performance of in vitro diagnostic (IVD) medical devices used within the EU. It was adopted in 2017 and came into effect on May 26, 2022, replacing the previous In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC). The IVDR introduced stricter requirements for the approval, performance, and post-market surveillance of IVD devices in the EU. To allow manufacturers and Notified Bodies to meet the new requirements, there are transitional periods for different device classes, with deadlines extending up to 2029 for certain legacy devices.
altona Diagnostics has been working for years on the development of products that meet the new requirements under the IVDR. With the granting of the IVDR QMS certificate, we have reached the milestone of being able to continue the availability of PCR testing products under the IVDR.
After these years of preparatory work towards our IVDR compliance, we have been awarded with the EU Certificate for Quality Management System under the new Regulation (EU) 2017/746 IVDR. Dr. Sven Cramer, our Head of Regulatory Affairs, points out: “IVDR compliance is in line with our commitment to providing products that can be used safely, show a consistently high performance and deliver robust and reliable results.”
Thanks to our anticipatory efforts to prepare products for the IVDR, we will be able to make both our AltoStar® and FlexStar® PCR testing assay product lines available to healthcare professionals in laboratories long before the new transition periods for legacy devices expire. The first wave of products of the automated workflow product line, AltoStar®, will be IVDR cleared as early as in the spring of 2025 starting with the AltoStar® Parvovirus B19 PCR Kit 1.5. This in vitro diagnostic test is based on real-time PCR technology and is intended to detect and quantify parvovirus B19 specific DNA in human plasma. Parvovirus B19 is a virus frequently tested for a bloodborne infection and for monitoring of transplant and immunocompromised patients.
Then in quick succession thirteen AltoStar® kits will be launched, among them our products of the transplant and immunocompromised panel.
Find out more about the altona Diagnostics approach to the IVDR.
altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany