Swissmedic: Which label requirements with CH-REP for medical devices? Swissmedic has published updated information regarding the labeling requirements for medical devices in Switzerland. These requirements apply to all stakeholders who wish to distribute or place medical devices on the Swiss market. Regulatory Basis The Medical Device Ordinance (MedDO) is closely linked to the Medical Device Regulation (MDR) (EU) 2017/745 and frequently references it. Therefore, compliance with MDR labeling requirements must be ensured. In addition, the specific labeling requirements of MedDO must be implemented. CH-REP Labeling Requirements The product or packaging must also display the CH-REP symbol , along with the name and address of the Swiss Authorized Representative (CH-REP). The CH-REP symbol and associated data must not obscure any essential information on the packaging. Detailed guidelines and reference documents are available on the Swissmedic website . Website and documents are available ...

Product Registration in Switzerland Swissmedic has published updated information regarding the product registration requirements on Swissdamed . These requirements apply to all stakeholders who wish to distribute or place medical devices on the Swiss market. Important Deadlines From July 1, 2026: All relevant products, systems, and treatment units must be registered with Swissmedic. By December 31, 2026: Full registration must be completed by the end of 2026 to ensure continued market access in Switzerland. Scope of Registration Requirement Currently, the registration requirement applies exclusively to Swiss manufacturers. Other economic operators, particularly Swiss importers, are not currently required to register products in Swissdamed. The planned change primarily affects the role of the Swiss Authorized Representative (CH-REP). Relevant Information Detailed information on registration requirements is available on the Swissmedic website under the "Medical Devices" section...

Responsibilities of the CH-REP The responsibilities of the CH-REP (Swiss Authorized Representative) are regulated in the Medical Devices Ordinance (MedDO). The CH-REP plays a central role in the regulatory process, particularly for companies based outside Switzerland that wish to distribute medical devices in the Swiss market. Representation of the Manufacturer The CH-REP acts as the legal representative of the manufacturer in Switzerland. It communicates with Swiss authorities, particularly with Swissmedic. It ensures compliance with Swiss medical device regulations. Documentation Obligations The CH-REP must keep all relevant documents (e.g., technical documentation, declaration of conformity) available. It ensures that the necessary evidence for the safety and performance requirements of the product is maintained. Upon request from authorities, these documents must be provided. A contract may be established to allow these documents to remain with the manufacturer and be provided upo...