Swissmedic’s experience with the regulatory changes for clinical investigations with medical devices implemented in 2021

Abstract

Swissmedic, the Swiss Agency for Therapeutic Products, evaluates and approves clinical trials of medical devices in humans if the devices are not CE-marked or are used off-label. These activities are conducted by the Medical Devices Clinical Investigations division, which also ensures continuous surveillance while the clinical trials are in progress. In 2021, the European Medical Device Regulation introduced new requirements for clinical investigations with medical devices. In parallel, the new Swiss Ordinance on Clinical Trials with Medical Devices came into force, applying the European requirements in Switzerland. This legislation introduced major changes to medical device requirements and authorisation procedures. In this article, Swissmedic summarises its stakeholder-oriented response to these legislative changes. In addition, it refers to new information sheets, templates, and decisions trees that are available.