EUROIMMUN, a PerkinElmer, Inc. company, today announced that as part of the transition to the new EU In Vitro Diagnostics Regulation 2017/746 (IVDR), risk class A products have been declared IVDR-compliant.
With the IVDR conformity assessment of class A products carried out under its own responsibility, EUROIMMUN has reached an important milestone in the IVDR transition. This ensures that laboratories in the EU can continue to use these products without interruption after the regulation has come into force.
The EU Regulation 2017/746 on in vitro diagnostic medical devices, which has been mandatory since 26 May 2022, creates a new legal framework for in vitro diagnostic medical devices that ensures a sustainable high level of safety, quality and health protection for patients and users on the European market.
“We have worked intensively over the last several years on the implementation of the new EU IVD Regulation in order to meet all requirements effectively and efficiently,” commented Dr Wolfgang Schlumberger, CEO of EUROIMMUN Medizinische Labordiagnostika AG. “Thanks to our expert teams, we were and are able to implement all relevant new regulations regarding 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.