MADX receives coveted IVDR approval for its cutting-edge molecular allergy test
MADX, a leading company in molecular allergy diagnostics, is happy to announce that it has successfully obtained approval under the In-Vitro Diagnostics Regulation (IVDR) of the European Union (EU)
This regulatory approval concerns in vitro diagnostic (IVD) products, which include medical devices and tests that are performed outside the human body, such as blood tests or laboratory tests.
This success once again confirms that MADx's molecular allergy test, known as ALEX² - The Allergy Xplorer, not only meets the highest standards, but also once again demonstrates its innovative strength by now also being registered as a Class C product in accordance with the strict EU IVDR guidelines.
IVDR approval is a mandatory authorisation for manufacturers of IVD devices to sell their products on the European market. The prescribed deadline for obtaining this authorisation is May 2027, but MADx has already received it three years earlier than required, which underlines the company's high-quality standards. In Austria, QMD Services, a subsidiary of Quality Austria, has been responsible for IVDR approval as a Notified Body since 23 December 2022 and also as a Notified Body for medical devices since May 2024.
Dr Christian Harwanegg, CEO of MADx, is proud of this milestone: ‘It is a great achievement that MADx has been IVDR-certified by the Notified Body QMD Services years before the deadline. It shows the innovative and future-oriented spirit of our company and our products. We will continue to work on advancing immunodiagnostics.’
Anni Koubek and Florian Heffeter, Co-Managing Directors of QMD Services GmbH, add: ‘Conformity assessment by a Notified Body is a key step in the market launch of IVDs. This involves checking the high European quality and safety standards in accordance with the IVDR. As a Notified Body, we support the provision of new and safe products to patients. It is extremely important that manufacturers understand and comply with the requirements of the IVDR in order to avoid legal problems and, above all, to protect the health of patients.’
MADx's molecular allergy test (ALEX²) is the leading blood test in its category and is characterised by the widest range of allergens tested (up to 300), providing a comprehensive picture of patients' sensitisation status. The results also provide doctors with valuable information on possible cross-reactions and individually suitable treatment options.
About MADX
Founded in 2016, MADx has established itself as a leading developer and manufacturer of high-precision allergy and food intolerance tests. The product range serves laboratories, medical practices, hospitals, and allergy centres worldwide. The company's focus is on the development of pioneering, intuitive immunodiagnostic solutions at the molecular level. With a presence in over 80 countries worldwide, the visionary MADx stands for dynamism, quality, and the promise of constantly pushing the boundaries of diagnostics in the field of allergy and food intolerance.
Questions and Contact
Mag. Barbara Schwarz
Marketing & Communications Lead
Macro Array Diagnostics GmbH
Lemböckgasse 59/Top 4
A-1230, Vienna
Tel.: +43 (0) 676 548 20 30
Mail: schwarz@macroarraydx.com