The Paul-Ehrlich-Institut has been designated by the European Commission as an EU reference laboratory (EURL) for in Vitro Diagnostic Medical Devices (IVDs) for the detection of blood grouping markers pursuant to Implementing Regulation (EU) 2025/2526 dated 16 December 2025. This designation expands the Institute's tasks as an EURL, having been responsible for high-risk IVDs for the detection of hepatitis viruses, retroviruses, and respiratory viruses since the end of 2023. The designation as an EURL for blood group determination underlines the Paul-Ehrlich-Institut's many years of expertise in the independent evaluation and testing of blood-based in vitro diagnostic medical devices.
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In vitro diagnostic medical devices (IVDs) for blood group determination generally fall into the highest risk class D according to the EU In Vitro Diagnostic Medical Device Regulation EU 2017/746 (IVDR). They are used to determine central blood group properties such as ABO and Rhesus characteristics and are therefore an essential prerequisite for the safe performance of blood transfusions, which may be carried out in emergency care, during surgical procedures, and in the context of blood donation.
The aim of the EU reference laboratories is to ensure uniform, high quality standards for such high-risk IVDs throughout Europe and thus to ensure the protection of patients and public health. The laboratories are tasked with duties such as independently verifying the performance and safety of class D IVD products, carrying out random tests of products and batches, and providing technical support to notified bodies and competent authorities.
Updated: 22.12.2025
