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IVDs

Transitional Timelines Unpacked: EU 2024/1860 and Its Impact on Legacy IVDs

Wednesday, May 6, 2026
08:30 - 09:30 WEST
Location: Pavilion 3
Learning Level: Advanced
Description: EU 2024/1860 revised the staggered transitional approach bringing in further requirements for IVD manufacturers and devices in order to benefit the transitional period and continue to place legacy devices on the market. Almost one year after the higher risk devices deadlines, what does the transition status look like? What are the challenges faced by the manufacturers and those of the notified body? What are the implications for other self-declared IVDs that must transition to IVDR today and next year? What challenges do notified bodies face in managing capacity, and what do manufacturers need to overcome to achieve compliance? Will the new Annex VII updates influence the progression of the transition?

It is paramount that manufacturers complete the essential steps towards IVDR. Delayed or incomplete actions may result in loss of EU market access, with clear financial and operational consequences.
The notified body will clarify the content of the amending regulation and share its latest experience and insights. The discussion will focus on the transitional status of IVDs based on the analysis of the most recent published dashboard of the “Study supporting the monitoring of availability of medical devices on the EU market” commissioned by DGSANTE, while also considering the deadlines for remaining self-declared IVDs. Consideration will be given to the possible bottlenecks that late applications (for Class C and Class B devices) may create, and the importance of timely engagement with a notified body especially in light of the new Implementing Act on Annex VII.

The session will highlight the challenges for notified bodies in accommodating the transitional requirements while managing internal resources and processes, and those of manufacturers to fulfil the requirements of the Amending Regulations. Case study examples will illustrate practical challenges and solutions. The discussion will also consider impacts on other economic operators.

Learning Objectives:

  • • Upon completion, participants will be able to describe the content and implications of the amending regulation EU 2024/1860 and those of the Implementing Act on Annex VII in the context of approaching deadlines for remaining self-declared IVDs, including challenges faced by both the notified bodies and manufacturers.
  • Upon completion, participants will be able to analyse survey data (GOEG) to assess the real-world status of the transition and identify critical risk areas.
  • Upon completion, participants will understand the impact of late applications and how they may create bottlenecks for notified bodies and manufacturers.