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  • Webinar
    Medical Devices

Rollout of EU Reference Laboratories for IVDR Class D devices

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

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This webinar will be mainly relevant for Class D IVD manufacturers.

What does the implementation of Regulation (EU) 2023/2713 mean for BSI, EURLs and IVD manufacturers of Class D devices.

  • 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.

Speakers

Hear from the experts in this webinar

Speaker

Alex Laan

Head of IVD Notified Body, BSI
Speaker

Sara Fabi

Regulatory Lead, IVDR, BSI
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