The PES-SLEEP project: A practical approach to the categorisation challenge for studies with medical devices

Abstract

Since the revised Medical Devices Ordinance (MedDO) and the new Ordinance on Clinical Trials with Medical Devices (ClinO-MD) entered into force in Switzerland in May 2021, clinical investigators have encountered challenges in correctly categorising their research projects and identifying whether their projects pertain to the category of clinical studies with medical devices (governed by the ClinO-MD) or are considered human research other than clinical trials (governed by Chapter 2 of the Human Research Ordinance (HRO)). In this article, we discuss the PES-SLEEP project in order to illustrate a practical approach to this categorisation challenge between the lighter HRO regulatory framework and the more demanding ClinO-MD pathway. We also present the important points that were considered by the ethics committee for the canton of Vaud (EC Vaud) in order for the study to be approved as an HRO research project.