Skip to main content
RAPS Euro Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
Sponsor Presentation
Sponsor Presentation
Ticketed Event
Ticketed Event
Evaluation

IVDs

Involving European Reference Laboratories in the Conformity Assessment of Class D Ivd's: Operational Update After 6 Months

Friday, May 16, 2025
11:45 - 12:45 CEST
Location: Copper Hall (level 0)
Learning Level: Advanced
Description: The objective of the panel discussion is to provide insights to the latest developments regarding the enrolment of European Reference Laboratories (EURLs) in accordance with article 100 of the IVDR. These EURLs have now been operational as of 1 October 2024, per amending EU regulation. The panel discussion will go into the journey to getting these laboratories online, involving not only presenters from notified bodies, EURLs, manufacturer and a representative of the European Commission involved in the development of the EU Regulation, covering the EURL requirements. Participants will get the latest views on EURLs and how they have implemented the requirements, alongside the views of the Notified Body. In addition, the implementation will be reflected upon by these different stakeholders; what went well and what may have been done better. The panel discussion will give further insights in what to expect in the next months to come for the implementation of performance verification and batch testing requirements.

Learning Objectives:

  • Upon completion, participants will be able to understand the process of getting EURLs online and making these operational to govern Class D IVD devices.
  • Upon completion, participants will be able to learn from what have worked well in the implementation process for EURLs and what manufacturers can learn from the new conformity assessment process carried out on Class D devices. What can be further improved in the oversight process for Class D devices from Notified Body perspective.
  • Upon completion, participant will be able to understand what this new process may mean for the compliance status of their own devices and how manufacturers can prepare for their Class D devices being verified for performance, including batch testing requirements.