Swiss device representation: distinguish mandate, registration and supply-chain roles
The acquired Swissmedic economic-operator guidance separates CH-REP, importer and distributor tasks. Its role table distinguishes the written representative mandate, PRRC arrangement and operator registration. Scope the actual Swiss role and portfolio; an EU appointment or SRN does not itself establish the Swiss arrangement.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · Switzerland
What changes the service scope?
Decision or task
What the source describes
What to prepare
Which actor and written mandate are involved?
The Swissmedic role table distinguishes the CH-REP mandate from importer and distributor obligations. [1]
Map manufacturer, representative, importer and distributor separately; specify covered devices and document access in the mandate.
How are PRRC and operator registration responsibilities covered?
The role table distinguishes representative PRRC and CHRN/operator registration from importer and distributor roles. [2]
Verify current applicable registration procedures and responsible-person evidence; keep device data and operator identity separate.
What evidence can each actor access and check?
The Swissmedic table provides role-specific document and checking responsibilities. [3]
Agree availability of the technical/conformity evidence and the distinct representative/importer/distributor checks against the original table.
How are operator changes reflected in device information?
The guidance’s change/address questions discuss the need to assess operator information changes rather than treating a mandate as a one-time file. [4]
Define who tracks changes, updates records/device information and assesses the applicable timing; no generic grace period is assumed.
The cited guidance is dated; current Swiss legal provisions, device/IVD distinctions, transition conditions, swissdamed applicability and actual mandate scope need review. No automatic EU/Swiss equivalence or completed registration is claimed.
A scoped evidence and handoff plan
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Which actor and written mandate are involved?
Map manufacturer, representative, importer and distributor separately; specify covered devices and document access in the mandate.
Useful evidence: Swiss supply-chain map, manufacturer identity, portfolio and written mandate.
How are PRRC and operator registration responsibilities covered?
Verify current applicable registration procedures and responsible-person evidence; keep device data and operator identity separate.
Useful evidence: Current operator registration evidence, responsible-person arrangement and ownership matrix.
What evidence can each actor access and check?
Agree availability of the technical/conformity evidence and the distinct representative/importer/distributor checks against the original table.
Useful evidence: Document index, access commitments and actor-specific checking procedure.
How are operator changes reflected in device information?
Define who tracks changes, updates records/device information and assesses the applicable timing; no generic grace period is assumed.
Useful evidence: Operator/address change log, affected labels/documents and current timing review.
Work packages and dependencies
Conditional: Swiss mandate, actor evidence and change-management scope — For this work package, agree the supported criteria, evidence access, covered entities/products and unresolved facts in the table above. Additional services require their own justified scope.
Questions for providers
Which exact actor, product or processing facts support the quoted scope, and what is still unresolved?
How will the listed records reach the responsible people, and who owns each change or authority request?
Which tasks and entities are excluded from the agreement, and which additional services need a separate assessment?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
