Regulatory Service

Regulatory readiness is a prerequisite for sustainable market access. Medddbase acts as your EU MDR and Swiss importer partner and helps you implement importer obligations in a structured, traceable, audit-ready way.

 For representation roles, Medddbase’s Regulatory setup is supported by QUNIQUE, which provides both the EU Authorized Representative (EU-REP) and the Swiss Authorized Representative (CH-REP) services as part of the overall compliance framework. 

Importer Services:

• CE mark & Declaration of Conformity verification
  Checks that the required conformity documentation and CE marking prerequisites are in place before products are placed on the market.
• EUDAMED & Swiss registration verification
  Confirmation that relevant registrations are completed correctly and remain consistent across required systems.
• Label check (manufacturer, authorized representative, importer details)
  Review of labeling to ensure mandatory information is present and compliant—one of the most common sources of nonconformity.
• Storage & transport conformity checks
  Verification that storage and transport follow required conditions and that applicable instructions are implemented.
• Traceability & complaint documentation
  Structured documentation to support product traceability and complaint handling—critical for surveillance and audits.
• Serious incident reporting support (as required)
  Assistance with timely and accurate reporting to authorities when reportable events occur.