Swiss Authorised Representatives (CH REP)
Overview
A Swiss Authorised Representative (CH REP) is a natural or legal person established in Switzerland who is mandated in writing by a non-Swiss manufacturer to perform or assist with the manufacturer's obligations under MedDO/IVDO. The CH REP is a mandatory requirement for every non-Swiss manufacturer before devices can be placed on the Swiss market. Legal basis: MedDO Art. 56–59.
Who Must Appoint a CH REP
Every manufacturer not established in Switzerland — including EU, UK, US, Japanese, and Australian manufacturers — must appoint a CH REP before placing devices on the Swiss market (subject to MRA status — see MRA with EU).
Establishment Requirement
The CH REP must be legally established in Switzerland with a registered office or branch with substantive operations. A postal address alone does not satisfy this requirement.
Key Obligations (MedDO Art. 57)
- Register or notify devices in DAPI before market placement
- Submit vigilance reports to Swissmedic via eVigilance
- Coordinate and notify FSCAs to Swissmedic
- Maintain the Declaration of Conformity and implant cards on file
- Cooperate with Swissmedic inspections and market surveillance
- Maintain processes for receiving and forwarding complaints
Joint and Several Liability
The CH REP is jointly and severally liable with the manufacturer for regulatory compliance in Switzerland — a significant legal exposure requiring careful contractual arrangements.
CH REP vs EU REP
| Aspect | CH REP | EU REP |
|---|---|---|
| Establishment | Switzerland | EU member state |
| Database | DAPI (Swissmedic) | EUDAMED |
| Vigilance reporting | To Swissmedic | To national CA |
| Joint liability | Yes | Yes |
| Can one person hold both roles? | Only if established in both | Only if established in both |
Official Sources
Related Pages
- CH REP — Full Obligations Guide
- Requirements for Non-Swiss Manufacturers
- MRA with EU — Current Status
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
As of the most recent updates, the CH–EU MRA operational status should be verified directly with Swissmedic, as its implementation affects whether CE-marked devices from EU manufacturers require CH REP appointment and DAPI registration. See MRA with EU — Current Status for the latest position.