Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges One Year On

Regulation (EU) 2017/746 (IVDR) establishes a specific regulatory framework for the conformity assessment of Class D devices. This framework involves not only a notified body but also a designated European Union Reference Laboratory (EURL) for device performance verification and batch release, as specified in IVDR Article 100(2)(a) and (b).

Following the designation of five EURLs under IA (EU) 2023/2713, this network became operational in October 2024. These EURLs cover four technical categories of Class D devices. Currently, no EURL has been designated for the remaining technical categories of Class D devices, which include arboviruses, hemorrhagic fever and other biosafety level 4 viruses, parasites, and blood grouping.

Regulation (EU) 2024/1860 mandates that manufacturers of Class D devices, if not already certified, must apply to an IVDR Notified Body (NB) by May 2025. Manufacturers and NBs must finalize written agreements by September 26, 2025, to benefit from the IVDD transition period until December 31, 2027. By May 2025, all IVD manufacturers must have implemented an IVDR-compliant Quality Management System (QMS) as required by Regulation (EU) 2024/1860.

Several months after the May 2025 deadline, a panel will review the progress and challenges faced by stakeholders in implementing the IVDR, EURL testing for Class D devices, and the revised transition dates. Key discussion points will include lessons learned and experiences from NBs, industry, and stakeholders. The panel will address questions such as the impact on the availability of Class D devices in the EU market and the potential designation of additional EURLs for the remaining Class D therapeutic areas.

Participants in this panel discussion will be able to ask questions about the certification process and performance evaluation of Class D IVDs to NBs and industry peers.  A representative from the EU Commission will also be invited to share the perspective of the EU regulator, as well as a representative of the EURL.