Interestingly it lists EUDAMED as N/A. What is the planning for the clinical module on reporting of serious adverse events and device deficiencies and related updates?
QA document on performance studies, and template and guidance for safety reporting in performance studies under IVDR is foreseen for Q3 2023.
https://health.ec.europa.eu/system/files/2023-03/mdcg_ongoing-guidance.pdf