Who Needs to Comply?
Overview
MedDO assigns specific obligations based on your role in the supply chain. The four primary roles are manufacturer, CH REP, importer, and distributor.
| Role | Established in Switzerland? | Conformity Assessment | DAPI Registration | Vigilance Reporting |
|---|---|---|---|---|
| Manufacturer | Not required | Yes (primary responsibility) | Yes (or via CH REP) | Yes (primary) |
| CH REP | Required | No (assists) | Yes (on manufacturer's behalf) | Yes (assists) |
| Importer | Required | Verify only | No | Report to manufacturer/CH REP |
| Distributor | Not required | Verify only | No | Report to manufacturer/CH REP |
Manufacturer
Responsible for ensuring device compliance, QMS, technical documentation, conformity assessment, declaration of conformity, and post-market obligations. Non-Swiss manufacturers must appoint a CH REP before placing devices on the Swiss market. See Manufacturers.
Swiss Authorised Representative (CH REP)
Mandatory for non-Swiss manufacturers. Performs or assists with Swissmedic registration, vigilance reporting, FSCA coordination, and inspections. Jointly and severally liable with manufacturer. See CH REP.
Importer — Any natural or legal person established in Switzerland who imports and places a non-Swiss manufacturer's device on the Swiss market without being the manufacturer themselves. Must verify device conformity, proper labelling (DE/FR/IT), and confirm CH REP appointment is in place. Has no registration obligation but must cooperate with Swissmedic surveillance activities and report any serious incidents to the manufacturer or CH REP.
Distributor
Makes a device available on the Swiss market without being the manufacturer or importer. Must verify labelling and cooperate with surveillance activities.
Swiss Authorised Representative (CH REP) Mandatory for non-Swiss manufacturers. Performs or assists with Swissmedic registration, vigilance reporting, FSCA coordination, and inspections. CH REPs are jointly and severally liable with manufacturers for regulatory compliance, including technical documentation accuracy, vigilance reporting, and FSCA implementation. Swissmedic can pursue enforcement action against either the manufacturer or CH REP independently. See CH REP.
Official Sources
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.