Switzerland

11/28/2022

Swiss Medtech welcomes Parliament’s instructions to the Federal Council to adapt national laws – enabling Switzerland to accept medical devices with FDA approval for the welfare of its own population Swiss Medtech welcomes Parliament’s instructions to the Federal Council to adapt national laws – enabling Switzerland to accept medical devices with FDA approval for the welfare of its population. Until now, healthcare providers and patients in Switzerland have only had access to medical devices with an EU certificate. It is essential that the order be implemented swiftly and pragmatically. Waiting cannot be an option if patient safety is at risk.

01/12/2023

Dealing with attestation gaps (MDCG 2022-18) This information sheet outlines how Switzerland implements MDCG 2022-18: Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate.

01/17/2023

Guide on Vigilance contact person for Medical Devices This document is intended to give hospitals, particularly the vigilance contact persons for medical devices, an overview of the development steps a product goes through before it is on the market and how it is then monitored on the market.

04/11/2023

Information Sheet on Clinical Investigations with Medical Devices This information sheet is valid under the new regulation that came into force on 26 Mai 2021, and it is intended for sponsors of clinical investigations of devices, contract research organizations (CROs), and investigators. It provides guidance on the authorization process, reporting requirements of sponsors, and the surveillance of clinical investigations by the Swiss Agency for Therapeutic Products, Swissmedic.

04/11/2023

Information Sheet on Clinical Investigations with Medical Devices This information sheet is valid under the new regulation that came into force on 26 Mai 2021, and it is intended for sponsors of clinical investigations of devices, contract research organizations (CROs), and investigators. It provides guidance on the authorization process, reporting requirements of sponsors, and the surveillance of clinical investigations by the Swiss Agency for Therapeutic Products, Swissmedic.

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