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Label Requirements with CH-REP

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 ...