EUROIMMUN, a PerkinElmer, Inc. company, announced today that all laboratory diagnostics in its portfolio have been brought into compliance with the requirements for risk class A products as part of the transition to the new European Union (EU) In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
With the completion of the IVDR compliance assessment, EUROIMMUN has reached an important milestone in the transition to the new IVDR rules. This ensures that laboratories in the EU can continue to use these products without interruption.
The IVDR, which came into force on 26 May 2022, established a new solid regulatory framework for in vitro diagnostic medical devices, which ensures a sustainable high level of safety, quality and health protection for patients and users in the EU.
“We have been working intensively on the implementation of the new EU IVDR over the past several years in order to meet all requirements effectively and efficiently,” comments Dr. Wolfgang Schlumberger, CEO of EUROIMMUN Medizinische Labordiagnostika AG. “Thanks to our expert teams, we were and are able to implement all the relevant new regulations with regard to increased patient safety and transparency.”
About EUROIMMUN Medical Laboratory Diagnostics AG
EUROIMMUN is an international provider of medical laboratory products for autoimmune, infection, allergy and molecular genetic diagnostics. The company’s portfolio encompasses indirect immunofluorescence assays (IFA), ELISAs, immunoblots, radioimmunoassays, chemiluminescence immunoassays (ChLIA) and molecular genetic test systems and spans over a thousand diagnostic parameters. State-of-the-art instruments and software provide efficient automation of analyses, increasing productivity and reliability in routine diagnostics. EUROIMMUN commands extensive know-how and a broad technology base allowing research, development and production to optimally meet the customer needs.
Laboratories in over 140 countries rely on EUROIMMUN test systems as well as automation and software solutions. Pioneering developments include BIOCHIP technology, designer antigens, recombinant-cell IFT and computer-aided immunofluorescence microscopy. Latest innovations include the EUROPattern Microscope Live with EUROLabOffice 4.0 software for ultrafast automated microscopy incorporating image classification using artificial intelligence.