Introduction
MDR introduced stricter requirements for clinical evidence, yet there is still uncertainty about how much clinical data different devices need for CE marking. This lack of consensus affects manufacturers, notified bodies, and ultimately, patient safety. ECliPSE (Evidence-based Clinical and Pre-Clinical Strategies for the Evaluation of Medical Devices) is a research that seeks to resolve this ambiguity by developing robust, evidence-based strategies that define when and how clinical and non-clinical data should be used in medical device evaluation. The primary objective of the survey is to systematically access the current practices, trends, and practitioner perspectives in the validation of ICU ventilator.
Participation in this survey is expected to require approximately five minutes. All responses will remain entirely anonymous to ensure confidentiality.
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