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Evaluation

IVDs

Critical IVDR Milestones & EU Reference Laboratories… a Testing Time

Thursday, May 15, 2025
16:45 - 17:45 CEST
Location: Copper Hall (level 0)
Learning Level: Advanced
Description: May 2025 represents a critical milestone following the publication of the EU IVD Regulatory (IVDR, (EU) 2017/746) and the publication of revised transition provisions ((EU) 2024/1860), particularly for Class D devices. In addition, these highest risk devices will have been under scrutiny by the newly operational EU Reference Laboratories (EURLs) since October 2024.

26 May 2025 was the deadline for IVD Directive (IVDD) EC-certified devices, and self-declared future Class D devices, to have certification against the IVDR. This is now the deadline when manufacturers of Class D devices must apply to an IVDR Notified Body (NB) if not certified already. The NB will need to accept applications by 26 September 2025, in order for devices to benefit from the IVDD transition until 31 December 2027. May 2025 is a new deadline when all to-be transitioned devices should have an IVDR-compliant QMS.

A critical enabler of IVDR is the designation and operation of EURLs for Class D devices. Following the designation of five EURLs ((EU) 2023/2713), this newly formed network becomes operational in October 2024. The transition of EURL testing aims to ensure that there is minimal disruption to supply. Testing will apply in full for Class D device applications submitted after 1 October 2024. For devices already in the conformity assessment process, or those already certified to IVDR, EURLs will only test newly released batches.

With the May 2025 deadline, revised transition dates and operation of EURLs, the panel will delve into the reality of IVDR implementation. Experiences of EURLs performing scrutiny of Class D devices, and other lessons learned, will be discussed. Will this impact availability of Class D devices? For successful IVDR implementation, all manufacturers should have implemented an IVDR-compliant QMS by May 2025. However, what are the experiences from NBs, industry and other stakeholders?...Testing times.

Learning Objectives:

  • Understand the status of IVDR implementation for the critical May 2025 deadline, notably Class D devices.
  • Describe how implementation is now taking shape for conformity assessment of Class D IVD devices, as EU Reference Laboratories are operational and will be performing batch releases for certified devices and performance evaluations for devices to be certified.
  • Understand what measures are needed, such as a IVDR QMS, to enable the successful transition of IVD devices to the transition deadlines, and impact on actions and decisions for industry.