The Swiss Federal Council has launched a public consultation on a new reporting obligation for supply shortages and disruptions affecting essential medical devices. According to the Federal Council’s press release, the proposal aims to strengthen Switzerland’s security of supply by extending the existing market monitoring system for essential medicinal products to medical devices.

Under the proposed framework, companies would be required to notify the Federal Office for National Economic Supply (FONES, Bundesamt für wirtschaftliche Landesversorgung BWL) of supply shortages and delivery interruptions affecting certain medical devices designated as essential. These include products whose unavailability could pose an immediate threat to patients’ lives or cause serious harm to their health.

The reporting obligation is intended to provide federal authorities with a more comprehensive overview of supply risks and enable timely intervention where necessary. To minimise administrative burdens, notifications would be submitted electronically through the existing therapeutic products reporting platform, which is already used for essential medicinal products.

The proposed ordinance would establish a dedicated reporting office for essential medical devices within FONES, building on the existing regulatory and technical infrastructure for monitoring shortages of human medicinal products.

The consultation will remain open until 28 January 2027, with the new reporting obligation expected to enter into force on 1 August 2027. The proposed measures represent a further step towards strengthening Switzerland’s ability to identify and address supply disruptions affecting critical healthcare products.