Users

Any professional who uses devices according to MedDO/IvDO and notices a serious incident is obliged by law to notify the supplier and Swissmedic.

The following guidance document applies to all professionals. It explains the reasons for the reporting obligation, defines what constitutes a serious incident, and specifies the information required for a complete incident report to Swissmedic.

Hospitals must take the «Schweizerische Gute Praxis der Materiovigilance im Spital (GPMV-Spital)» into account (see section «Vigilance in hospitals»). For matters specifically concerning in vitro diagnostic medical devices (IVDs), the «Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik (GPMV-IVD)» applies (see section «Vigilance in in vitro diagnostics»).

Responsibility for deciding whether an incident is serious and therefore subject to the reporting obligation lies with the user. If the incident is serious, Swissmedic must be notified (materiovigilance@swissmedic.ch) using the following form, which must be submitted electronically and in machine-readable format: 

Please note that Swissmedic does only accept user notifications that have been completed in full and are submitted using the form above.

Hospitals should regard the GPMV-Spital as the reference work for vigilance concerning medical devices, excluding IVDs. It contains comprehensive information on the reporting requirements for serious incidents, the management of field safety corrective actions (FSCA) in hospitals, and the responsibilities of the vigilance contact person for medical devices. For quick orientation, each chapter of the GPMV-Spital begins with a summary under «Das Wichtigste in Kürze» (Key points at a glance).

For specific questions about IVD, please refer to the GPMV-IVD (see section «Vigilance in in vitro diagnostics»).

Hospitals are legally obliged to notify Swissmedic of new vigilance contact persons for medical devices or if the contact details of existing registered contact persons change. The vigilance contact person can be responsible for medical devices according to the Medical Devices Ordinance of 1 July 2020 (MedDO; SR 812.213) or according to the Ordinance of 4 May 2022 on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), or for medical devices according to both ordinances. Please complete the following notification form and send it to materiovigilance@swissmedic.ch

Swissmedic inspects hospitals’ reporting systems. The following document provides a checklist covering the key points.

The «Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik (GPMV-IVD)» serves as a reference document for vigilance involving IVDs used in laboratories or in point-of-care testing (POCT) for medical purposes. Publication is planned for 2026. The GPMV-IVD will provide detailed information on the reporting requirements for serious incidents and on the management of field safety corrective actions (FSCA) involving IVDs.