Overview

Class D IVD manufacturers will gain more insights in the newly enrolled EURL regulation and will be better prepared for the engagement between BSI and the EURLs.

Key takeaways and learning objectives

The webinar will answer the following questions:

• What is the status of the implementation of the EURLs becoming operational, as of October 1, 2024?
• What does the implementation of Regulation (EU) 2023/2713 mean for BSI, EURLs and IVD manufacturers of Class D devices?
• What will happen after October 1, 2024, with the Class D IVDs that have been previously certified as a Class D IVD, or are in application? And what will happen with Class D IVDs that have applied for conformity assessment after October 1, 2024?
• What is going to be the workflow of Class D IVD manufacturers, EURLs and BSI for the oversight process of Class D IVDs?
• What will the EURLs expect to receive from BSI and IVD manufacturers after October 1, 2024?
• How will the Class D IVD batch verification and performance verification process be monitored?
• What kind of engagement is expected from IVD manufacturers in relation to the EURLs?

Presenter information

Speaker - Alex Laan, Head of Notified Body - IVD

Speaker - Sara Fabi, Regulatory Lead - IVD