MDR 2017/745 AND IVDR 2017/746
Medical device distributor compliance and the evidence workflow
SHORT ANSWER
A distributor in the European Union verifies, before making a device available, that it carries the CE marking and an EU declaration of conformity, that the instructions for use are provided in the language required by the destination country, that a UDI has been assigned and that an authorised representative is identified for imported devices. Those checks come from MDR Article 14 and IVDR Article 14 and must be evidenced by dated review records. National rules add the language, registration and responsible person requirements of each Member State.
This page describes the distributor and importer workflow across the Union and where national requirements differ. Europe is not a single local regulatory market: obligations under the Regulations are shared, while language, registration and enforcement practice are national.
Expert review: Marcia Elena Podboršek, MPharm, MedDev Rešitve
The evidence workflow
1. Determine the economic operator role
Importer duties under Article 13 apply when a device from outside the Union is placed on the Union market. Distributor duties under Article 14 apply along the supply chain inside the Union. One company can hold both roles for different consignments, and relabelling or repackaging can bring Article 16 obligations.
2. Run the pre-supply verification
Check the CE marking, the EU declaration of conformity, the instructions and labelling in the required language, the UDI assignment and, for imported devices, the authorised representative. Article 14(2) allows a sampling method proportionate to volume and risk instead of unit by unit inspection.
3. Record the evidence
Each check produces a dated record: what was verified, by whom, against which document version, with the findings and the decision. Storage and transport conditions are logged where the manufacturer specifies them (Article 14(3)).
4. Escalate discrepancies
Where a device is suspected not to be in conformity, it is not made available. The manufacturer, the authorised representative or the importer is informed and, in cases of falsified devices or serious risk, the competent authority (Article 14(4) and 14(5)).
5. Keep traceability and cooperate
Maintain the register of suppliers and recipients required by Article 25, cooperate with competent authority requests and keep complaints, non-conforming devices, recalls and field safety corrective actions in one register (Article 14(4) and 14(6)).
Distributor duties and the evidence they produce
Article references are to MDR 2017/745. IVDR 2017/746 mirrors these duties for in vitro diagnostic devices.
| Duty | Legal basis | Evidence |
|---|---|---|
| CE marking and EU declaration of conformity verified | MDR Art. 14(2)(a) | Dated review record with the declaration version attached |
| Instructions and labelling in the required language | MDR Art. 14(2)(b), Annex I 23.1 | Enclosed national language version and its revision number |
| UDI assigned by the manufacturer | MDR Art. 14(2)(c), Art. 27 | UDI-DI recorded and cross-checked against EUDAMED |
| Authorised representative identified for imported devices | MDR Art. 14(2)(d), Art. 11 | Name and address captured from label or packaging |
| Storage and transport conditions respected | MDR Art. 14(3) | Temperature and humidity logs against manufacturer limits |
| Complaints, non-conformities, recalls registered | MDR Art. 14(4), Art. 14(6) | Register with actions and notifications sent |
| Suppliers and recipients traceable | MDR Art. 25 | Traceability list retained for the applicable period |
| Sampling method defined and applied | MDR Art. 14(2) | Written method with the rationale for the sample size |
What an inspection-ready record contains
Structure of a single device review, independent of the tool used to produce it.
- Device identification: name, model, class, Basic UDI-DI
- Role for the consignment: distributor or importer
- Fields verified, each linked to a source document and version
- Findings, including anything that did not match
- Action taken: release, hold, request to the manufacturer
- Reviewer, confirming responsible person and dates
- Retention reference so the record can be produced on request
Where audits usually find gaps
- Documents are archived without any record that a review took place.
- The sampling method is described verbally but never written down.
- National language requirements for the destination country are assumed rather than verified.
- UDI data is copied from the supplier without checking the EUDAMED entry.
- Findings are resolved by email with no link back to the device record.
Frequently asked questions
Does a distributor register in EUDAMED?
Actor registration in EUDAMED is required for manufacturers, authorised representatives and importers. Distributors are not registered as actors under the Regulations, although national law can require a separate notification to the competent authority. Verify the requirement for each Member State where you operate.
How does IVDR differ for importers and distributors?
The structure of the duties is the same: Article 13 for importers and Article 14 for distributors, with device data and UDI obligations attached. The transition timelines and class rules differ, so the applicable date must be established per device cohort.
Which parts of EUdaMed AI are available today?
Document and label review with a drafted review record, the device register, sampling plans and CAPA tracking are the current focus. Additional modules are stated as planned on the product pages. The platform supports the decision; it does not certify conformity and does not replace the responsible person.
Related pages
See the workflow on your own devices
Book a demonstration or join the waiting list. We review a sample of your device documentation and show the record an inspector would receive.