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Requirements for Non-Swiss Manufacturers

Overview​

Any manufacturer not established in Switzerland must comply with Swiss-specific requirements in addition to standard MedDO/IVDO technical requirements. The key Switzerland-specific obligations are:

1. Appoint a CH REP (Mandatory)​

A CH REP established in Switzerland must be appointed before placing any device on the Swiss market. This is mandatory regardless of CE marking status (subject to MRA). See CH REP — Full Obligations Guide.

2. Complete MedDO/IVDO Conformity Assessment​

The device must comply with all applicable MedDO or IVDO requirements. For most non-Swiss manufacturers, the EU MDR/IVDR conformity assessment (using an EU-designated NB) satisfies this requirement — as MedDO mirrors EU MDR technically.

3. Register in DAPI​

The CH REP registers or notifies the device in DAPI before or within 30 days of first market placement. See Registration Overview.

4. Swiss Labelling in DE/FR/IT​

Device labelling and IFUs must be provided in German, French, and Italian. This is a Switzerland-specific requirement that differs from EU MDR language requirements.

5. Post-Market Obligations​

Maintain active vigilance reporting to Swissmedic via eVigilance; implement PMS per MedDO; coordinate FSCAs for Swiss distribution via the CH REP.

Summary Compliance Checklist​

  • CH REP established in Switzerland appointed
  • MedDO/IVDO conformity assessment complete
  • Declaration of Conformity referencing MedDO issued
  • Device registered/notified in DAPI by CH REP
  • Labelling available in German, French, and Italian
  • Vigilance reporting process to Swissmedic eVigilance established
  • FSCA coordination process with CH REP in place
  • CH REP mandate covers all devices being registered
Disclaimer

AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.