Special Device Types
Devices with specific rules, obligations, or pathways under MedDO/IVDO.
| Page | Covers |
|---|---|
| Custom-made Devices | MedDO Art. 50–52; statement requirements; no CE mark; CH-specific statement form |
| Sterile Devices | Class Is; NB involvement; EN ISO 11135, 11607 sterility requirements |
| Measuring Devices (Class Im) | Class Im; NB involvement; metrological requirements; METAS interface |
| Devices Incorporating Medicinal Substances | Class III; ancillary medicinal assessment; Swissmedic drug division consultation |
| Devices Using Human/Animal Tissue | MedDO Annex I Ch II §13; TSE requirements; Swissmedic blood/tissue authority |
| IVD Companion Diagnostics | Definition; co-development with medicinal product; simultaneous authorisation |
| Software & AI as Medical Device | Qualification; AI/ML lifecycle; Swissmedic expectations |
| Reusable Surgical Instruments (Class Ir) | Class Ir; NB involvement; reprocessing information; IFU obligations |
| Single-use Devices | Prohibition on reprocessing; labelling obligations; Swissmedic guidance |
| Combination Products | Drug-device; primary mode of action; dual regulation pathway |
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