Hear our subject matter experts Alex Laan, Head of Notified Body – IVD, Sara Fabi, Regulatory Lead – IVD as they discuss the newly enrolled EURL regulation. Class D devices manufacturers will gain more insights in the newly enrolled EURL regulation and will be better prepared for the engagement between BSI and EURLs.
The webinar will answer the following questions and more:
What does the implementation of Regulation (EU) 2023/2713 mean for BSI, EURLs and IVD manufacturers of Class D devices?
What is the status of the implementation of the EURLs becoming operational, as of October 1, 2024?
What will happen after October 1, 2024 with 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?
