Cruxi
Service decision and evidence guide
For a manufacturer outside a Member State, the acquired MDR Article 11 links Union market placement to a sole authorised representative. The useful buying decision is the device-group coverage and tasks in the accepted written mandate, including documentation, registration checks and authority cooperation. Several manufacturer obligations cannot be delegated through that mandate.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · EU
| Decision or task | What the source describes | What to prepare |
|---|---|---|
| Which devices does the mandate cover? | Article 11(1)–(2) describes a sole representative, written acceptance and coverage at least for the same generic device group. [1] | Map legal manufacturer, establishment and device groups; identify additions and exclusions before signing. |
| What evidence must be available? | Article 11(3) includes checks of the declaration and technical documentation, applicable conformity assessment, copies of documentation/certificates and registration checks. [1] | Define document access, version changes, registration ownership and authority-request handling in the scope. |
| What stays with the manufacturer? | Article 11(4) specifies manufacturer obligations that the mandate shall not delegate. [1] | Separate representation from quality, technical-documentation and post-market work; do not treat the appointment as a transfer of all compliance work. |
| What PRRC arrangement is relevant? | Article 15(6) describes expertise and permanent, continuous PRRC availability for authorised representatives. [2] | Ask how the representative meets its PRRC responsibility; assess the manufacturer PRRC arrangement separately. |
This page covers the cited MDR appointment provisions. IVDs, other product legislation and buyer-specific coverage need separate assessment; an EMDN name alone does not establish class or applicability.
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.
Map legal manufacturer, establishment and device groups; identify additions and exclusions before signing.
Useful evidence: Manufacturer identity, device-group portfolio and proposed mandate.
Define document access, version changes, registration ownership and authority-request handling in the scope.
Useful evidence: Document index, declarations, applicable certificates, record ownership and escalation matrix.
Separate representation from quality, technical-documentation and post-market work; do not treat the appointment as a transfer of all compliance work.
Useful evidence: A mandate/deliverables matrix checked against Article 11(4).
Ask how the representative meets its PRRC responsibility; assess the manufacturer PRRC arrangement separately.
Useful evidence: Named responsible people, qualification evidence, availability and backup arrangements.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
Thu, 10 Sep 2026 17:31:54 GMT · retrieved 2026-10-06
Source key D05 · snapshot fd42f74592a6a3ac614be3505c16b24acc814c725637749534fcbff0c5d411d6
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
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