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Declaration of Conformity

Required Content (MedDO Annex IV)​

  1. Manufacturer's name and address (or CH REP where applicable)
  2. Device identification — name, model number(s), BASIC UDI-DI (where applicable)
  3. Confirmation that the device conforms to MedDO (or IVDO) and any other applicable Swiss legislation
  4. Reference to the conformity assessment procedure followed (Annex IX, X, XI, or IV)
  5. Reference to harmonised standards or common specifications applied
  6. Reference to NB (name, ID number, certificate number) where NB involvement was required
  7. Date and place of issue
  8. Signature of authorised signatory

CH REP Role​

The Declaration of Conformity is issued and signed by an authorised signatory of the manufacturer (typically the responsible person for regulatory compliance). Where a Swiss representative (CH REP) is appointed, the CH REP does not sign the Declaration of Conformity but must maintain a copy and make it available to Swissmedic on request without delay. The CH REP is identified as the authorised Swiss contact in the DAPI registration.

Retention​

  • 10 years from last device placed on market (general devices)
  • 15 years (implantable devices) Must be provided to Swissmedic upon request.

Official Sources​

Disclaimer

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