Harmonization process of European Reference Laboratories for in vitro diagnostics 2025

EU reference laboratories ('EURLs') are a crucial new type of scientific bodies in the diagnostics sector put in place by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU . These laboratories carry out a number of tasks for high-risk diagnostics, including e.g., infection control tests for blood transfusions and SARS-CoV-2 tests. Part of the EURLs tasks is funded by fees from notified bodies and Member States, but a significant part may not be covered by fees. Funding for EURLs is especially crucial in the setting up phase to ensure a successful start and provide the necessary predictability for the laboratories to carry out their tasks, which are essential for the successful implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices ('IVDR'). Article 100(6) of Regulation (EU) 2017/746 provides for a Union contribution for EU reference laboratories which is essential to enable these tasks to be fulfilled. Funding for EURLs is especially crucial in the setting up phase to ensure a successful start and provide the necessary predictability for the laboratories to carry out their tasks, which are essential for the successful implementation of the IVDR. It implements the EU4Health Programme's general objective of strengthening health systems by improving their resilience and resource efficiency (Article 3, point (d), of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (c), (h) and (i), of Regulation (EU) 2021/522.