Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Head of IVD Notified Body BSI Amsterdam, Noord-Holland, Netherlands
Description: 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 the participation of 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 Implementing Act (EU) 2023/2713, this network became operational in October 2024. These EURLs cover four technical categories of Class D devices: Hepatitis and retroviruses, Herpesviruses, Bacterial agents, and Respiratory viruses causing life-threatening diseases. Previously, 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. But now, the EURLs are expanding as a result of the second call from EU and so do two of the technical areas where EURL oversight is applied, as of May 1, 2026. 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 have the opportunity to ask questions about the certification process and performance evaluation of Class D IVDs to EU Reference Laboratories, Notified Bodies, and industry peers. A representative from the EU Commission will also be invited to share the perspective of the EU regulator.
Learning Objectives:
Upon completion, participants will be able to understand the necessary measures for a successful transition to the IVDR, including the implementation of an IVDR-compliant Quality Management System (QMS).
Upon completion, participants will be able to support the completion of the conformity assessment process for Class D IVDs under the IVDR.
Upon completion, participants will be able to assist in the ongoing performance evaluation of Class D IVDs under the IVDR, including EURL testing.
