Swissmedic

MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.

Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.

MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.

Healthcare professionals must report all serious incidents involving injectable devices to Swissmedic as outlined in the new guidance.