Switzerland: Updates on Safety Measures and IVD Labelling

The regulatory environment in Switzerland is evolving to strengthen both the safety management of medical and in vitro diagnostic (IVD) devices during clinical trials and the traceability of Medical Devices already placed on the market.

Notification Form for Safety Measures in Clinical Trials

Swissmedic, the Swiss Agency for Therapeutic Products Safety, has recently released the form BW610_20_022e_FO Notification of safety measures MD IVD for reporting safety measures related to clinical trials of Medical Devices and IVDs.

This module allows notification of early termination, interruption or temporary suspension of a clinical trial for safety reasons, thus contributing to continuous and timely risk monitoring.

By Articles 36(4) and 38 of the Ordinance on Clinical Trials of Medical Devices (OSRUm-MD) and Article 34 of the same Ordinance, the module supports timely management of adverse events during the trial.

The joint use of the guidance documents ‘BW600_00_015i_MB for Clinical Investigations of Medical Devices‘ and ‘BW600_00_016i_MB for Interventional Performance Studies of IVDs’ provides a comprehensive framework for manufacturers and promotes regulatory compliance.

Mandatory CH-REP on IVDs Label

Until March 31, 2025, the instructions from the CH-REP for in vitro diagnostic Medical Devices may alternatively be provided in a document accompanying the device, such as a delivery note. After this date, devices subject to this extension and placed on the market from March 2025 onwards must comply with the labelling information requirements of the current ODIV.

Summary of deadlines:

– Until March 31, 2025: CH-REP may be indicated on accompanying documentation.

– As of April 1, 2025: Devices subject to this extension must comply with the labelling information requirements of the current ODIV.

Implications

Manufacturers are required to update their compliance procedures, both for the management of clinical trials and for the labelling of IVD devices intended for the Swiss market.

>>> Thema can support you as a Swiss Authorized Representative (CH REP) and assist you with all the regulatory requirements necessary for access to the Swiss market

SOURCE:

https://www.swissmedic.ch/swissmedic/it/home/news/updates/updated_documents/jan-2025.html

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/ch-rep.html?

03/19/2025