Distributor or Importer? Understand Your Role Under EU MDR

Start with the transaction, not the job title

Under MDR, placing on the market is the first making available of an individual device on the EU market. Making available includes commercial supply for distribution, consumption or use, whether paid for or free. The question concerns the actual units, not whether the same model has already been sold somewhere in Europe.

Map the legal manufacturer, seller, buyer and any intermediary for the units you plan to supply. Check where each business is established, who obtains ownership, possession or another property right, and who first places the units on the EU market. Physical handover is not always needed for a legal transfer. Purchase orders, supply agreements and shipment records should tell the same story.

The scenarios below concern ordinary MDR supply routes. In vitro diagnostic devices follow IVDR. For a legacy device supplied under Article 120, review the transition provisions separately; do not automatically apply every MDR labeling and UDI check below to it. Custom-made devices, system or procedure packs and direct clinical-use arrangements also need their own factual review.

Five common supply-chain scenarios

These are hypothetical examples based on the stated facts. If the legal manufacturer, transaction or earlier placement changes, revisit the conclusion. Customs arrangements and physical shipping routes should support the analysis, rather than replace it.

If you are the importer: own the Article 13 checks

• Verify before placement. Check CE marking and that the EU declaration of conformity has been drawn up. Identify the manufacturer and its required authorised representative. Verify MDR labeling, required instructions for use and UDI assignment where applicable. Match the evidence to the actual model and supplied condition.
• Identify your business. Put the importer’s required name and contact details on the device, its packaging or an accompanying document. Additional labeling must not obscure the manufacturer’s information. An authorised representative acts under the manufacturer’s mandate; appointing one does not by itself identify the importer. If one business performs both roles, it must meet both sets of duties.
• Keep the conformity records. Retain the declaration and any relevant notified-body certificate, with amendments and supplements, for the Article 10(8) period: at least ten years after the last device covered by the declaration is placed on the market, or fifteen years for implantable devices. An ISO certificate or a supplier’s assurance does not replace these records.

If you are the distributor: verify before onward supply

Article 14 requires due care and checks before you make a device available. Verify CE marking, that the declaration has been drawn up, the required manufacturer information, and UDI assignment where applicable. For imported devices, verify the importer has supplied the identification required by Article 13(3). Buying from an EU wholesaler does not remove these duties.

Representative sampling is allowed for the Article 14(2)(a), (b) and (d) checks. The importer-identification check in point (c) is not included in that sampling permission. MDCG guidance allows documentation checks in exceptional, justified cases where physical checks of every device cannot reasonably be achieved without compromising packaging integrity or compliance. Record how you performed and justified the checks.

For example, if the declaration identifies one model but the delivered label shows another, hold the affected supply while the discrepancy is resolved. Request access to the declaration and trace the units to the actual importer; do not treat a distributor agreement as evidence that the product checks have already been completed.

Registration and traceability follow the role

Importers register as actors in EUDAMED under Article 31. The Commission states that use of the Actor module became mandatory on 28 May 2026. An importer should check its actor registration and SRN, the manufacturer/authorised-representative information and the applicable device-registration requirements and transition dates. Actor registration and device registration are separate checks; an SRN is not product approval.

A business acting only as a distributor does not register in EUDAMED as a distributor. Member States may require national distributor registration, so check the rules in the countries where you supply. Both roles need traceability that allows the competent authority to identify the relevant direct suppliers and recipients under Article 25. Keep model and batch/serial information useful for tracing affected deliveries.

A warehouse or service contract does not transfer your duties

A logistics provider is not automatically an MDR importer or distributor. Assess its actual activities and rights over the devices; a provider that also meets one of those definitions must fulfil that role. Outsourcing transport, storage or operational checks does not transfer the importer’s or distributor’s legal responsibility.

Specify temperature and other manufacturer-set storage and transport conditions, handling of damaged packages, records and escalation contacts in the service agreement. Importers must ensure conditions do not jeopardise conformity; distributors must comply with the manufacturer’s conditions while the devices are under their responsibility. Verify that the agreed process is actually followed.

Pause before changing the brand, instructions or packaging

Article 16 can make manufacturer obligations apply if you supply a device under your own name or trademark, change its intended purpose, or modify it in a way that may affect compliance. The own-name rule has an exception where an agreement leaves the manufacturer identified as such on the label and responsible for the manufacturer’s MDR duties. Review the actual arrangement before launching a private-label range.

Some necessary translations and outer-packaging changes fall within Article 16(2) instead. That route has conditions, including identifying the activity and operator, a quality management system certified by an appropriately designated notified body, and the Article 16(4) manufacturer/authority notifications at least 28 days before supply. The certificate concerns that quality system, not a new conformity certificate for the device.

Simply dividing a shipment into smaller quantities while preserving the manufacturer’s device packaging is not automatically Article 16 repackaging. Opening or damaging a sterile barrier is a different matter. Activities performed on behalf of, and under the control of, the manufacturer also need to be distinguished from an independent trader’s Article 16 route.

Keep complaint and supply-warning routes working

Both roles must maintain the required complaint, non-conformity, recall and withdrawal registers, immediately forward suspected-incident reports upstream and cooperate on corrective action. Do not place or further supply a device when you have reason to believe it is non-compliant until conformity is restored. Serious risks and falsified devices trigger additional competent-authority duties; serious risks after placement also require the importer to notify the relevant notified body where applicable.

There is also a downstream information duty under Article 10a. If you receive the manufacturer’s notice of a qualifying anticipated supply interruption or discontinuation, pass the information without undue delay to the economic operators, health institutions and healthcare professionals you directly supply. Preserve the manufacturer’s communication. Do not wait for a customer complaint before forwarding it.

Record one role decision for each supply route

Before the first order, record the legal entities, actual units/model, earlier EU placement evidence, your role and its rationale. Assign owners for verification, importer labeling where needed, registration, storage, traceability and escalation. Keep the supporting agreements and documents together. Revisit the decision when you change the source, brand, packaging or shipping arrangement; the next order may create different duties.

Review your MDR supply-chain role with Regunow

Use Regunow to research the MDR provisions, examine supply agreements and compare the evidence behind your importer or distributor role. Bring the transaction facts and open responsibility questions together for your regulatory team’s review.