Safeguard Procedures
Overview
Safeguard procedures are formal mechanisms for restricting or prohibiting devices that present a risk even if CE-marked. MedDO mirrors EU MDR Art. 90–96 safeguard clause provisions.
Swissmedic Protective Measures
Where Swissmedic determines a CE-marked or Swiss-registered device presents a risk, it can:
- Restrict use to specific settings or users
- Require labelling changes or additional warnings
- Prohibit market placement of the device in Switzerland
- Order device recall and customer notification
Swissmedic Safety Communications
Swissmedic may issue safety communications to healthcare professionals, patients, and the public. These may:
- Accompany a manufacturer FSCA
- Be issued independently following Swissmedic market surveillance findings
- Alert users to a risk pending manufacturer action
Safety communications are published on the Swissmedic website and may be distributed through cantonal health authorities and professional associations.
Coordination with EU Competent Authorities
Where Swissmedic takes protective measures against a CE-marked device, it notifies the relevant EU member state competent authorities. Similarly, Swissmedic receives information about EU safeguard measures and evaluates whether parallel action in Switzerland is warranted. This coordination operates through bilateral arrangements and the EU RAPEX/EUDAMED safety alert exchange mechanisms.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.