Cruxi
Service decision and evidence guide
MDR Articles 13 and 14 describe different checks and follow-up duties for importers and distributors. Build the project around the actual supply-chain role, declarations, labels, UDI where applicable, storage controls and complaint escalation. A freight or customs contract does not by itself establish the MDR role.
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 |
|---|---|---|
| What is checked before supplying? | Article 13(2) lists importer checks including CE/declaration, identified manufacturer/representative, labels/instructions and applicable UDI. Article 14(2) lists distributor checks and permits representative sampling for specified items. [1] [2] | Create separate importer and distributor checklists; document which sampling provisions actually apply. |
| Whose contact goes with the device? | Article 13(3) specifies importer name and contact information, without obscuring manufacturer information; Article 14(2)(c) asks distributors to check this for imported devices. [1] [2] | Compare packaging and accompanying-document examples with the importer-identification requirement. |
| Who controls storage and transport? | Articles 13(5) and 14(3) address conditions while devices are under the respective operator’s responsibility. [1] [2] | Allocate storage, transport, deviations and evidence access by actual custody stage. |
| How do incidents and nonconformities move? | Both articles describe notification/cooperation and complaint or recall/withdrawal records, with role-specific details. [1] [2] | Agree who logs, forwards, investigates and supplies authority information; retain each operator’s responsibilities. |
The definition of the buyer’s actual actor role and the applicable device regime remain unresolved. This comparison is MDR-specific and does not establish customs importer-of-record obligations.
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.
Create separate importer and distributor checklists; document which sampling provisions actually apply.
Useful evidence: Supply-chain map, declarations, representative details, labels/IFU and UDI records.
Compare packaging and accompanying-document examples with the importer-identification requirement.
Useful evidence: Label artwork, importer identity/address and change control.
Allocate storage, transport, deviations and evidence access by actual custody stage.
Useful evidence: Manufacturer conditions, transport/storage records and deviation escalation.
Agree who logs, forwards, investigates and supplies authority information; retain each operator’s responsibilities.
Useful evidence: Complaint/recall registers and a manufacturer–representative–importer–distributor escalation matrix.
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.
Compare Find Importer & Distributor Compliance Providers | Get Quotes