IVDR Article 13: Importer Obligations for Devices From Third Countries

1. Key takeaways

The importer is the economic operator that places devices from a third country on the EU market. Article 13 requires it to verify, before placing a device on the market, that the device bears the CE mark and is accompanied by an EU Declaration of Conformity; that the manufacturer is identifiable and, where applicable, has appointed an authorised representative; and that the device is supplied with instructions for use and safety information and carries a UDI as applicable per the phase-in. Where the verification is not satisfied, the device may not be placed on the market, and the importer must inform the manufacturer and, where applicable, the authorised representative. Importers therefore stand as the statutory gatekeeper for third-country IVDs: their verification duty is not a formality, their own registration under Article 28 brings them into the SRN system, and Article 16 can convert them into manufacturers if they overstep their role.

2. Legal basis

3. Expert insights

Insight 1: The importer is the only statutory role that gates the EU border externally.

What the importer performs under Article 13 is not a box-ticking check: the provision requires confirmation that the conformity documentation chain of the device is complete, covering the CE mark, the Declaration of Conformity, an identifiable manufacturer and, where applicable, an authorised representative, plus the instructions for use and the UDI. For a manufacturer outside the EU, this means the importer has both the right and the duty to demand these documents before the goods move onward. Treating the importer as a pure logistics actor exposes both sides during market surveillance: when authorities trace a non-conforming device backwards through the supply chain, the importer is the first EU-resident checkpoint, and its records decide whether the whole chain can demonstrate conformity or whether both the importer and the manufacturer face enforcement simultaneously.

Insight 2: Importers must also register and obtain an SRN themselves.

Article 28(1) lists the manufacturer, the authorised representative and the importer side by side as the economic operators that must register in the electronic system referred to in Article 30. Article 28(3) requires the manufacturer to use its SRN when submitting an application to a notified body and when accessing EUDAMED to fulfil its Article 26 obligations. An importer without an SRN therefore breaks data submission for the entire chain: conformity assessment applications, device registration under Article 26 and public retrievability of actor data all depend on the actors being registered and verified by a competent authority. Importers that are subsidiaries or affiliates of the non-EU manufacturer should pay particular attention here, because the SRN is issued per legal entity: a group structure with several importing entities inside the EU means several actor registrations, several SRNs and several sets of confirmation deadlines, each of which can independently stall the chain if left unverified.

Insight 3: Article 16 is the identity risk point for importers.

If an importer places devices on the market under its own name or registered trademark, changes the intended purpose of devices already placed on the market, or modifies devices in a way that may affect conformity with the applicable requirements, it is deemed to be the manufacturer and assumes the obligations of Article 10 (Article 16(1)). Private labelling, repackaging and amending instructions for use are the three most common trigger paths, and the second of the three typically starts from a marketing department request rather than from a regulatory decision, which is why an upfront Article 16 assessment belongs in the commercial review process (see the dedicated article on Article 16 in this series).

Insight 4: The UDI retention duty makes the importer part of the traceability chain.

Article 24(8) requires economic operators to retain the UDIs of devices they supply or receive. As the first link into the EU, the UDI records of the importer are the starting data for market surveillance and vigilance traceability: authorities reconstruct where a device entered the Union, which batches moved onward and which actors handled them. An importer ledger that is inconsistent with the manufacturer and distributor records breaks that reconstruction and can turn a contained incident into a broader enforcement matter. In practice, the ledger should capture at minimum the UDI or Basic UDI-DI, the batch or serial numbers received and supplied, the trading partners on both sides and the dates of receipt and supply, and it should be retained for a period consistent with the traceability expectations applied to the rest of the chain, since authorities typically request these records together with the Article 13 verification evidence rather than separately.

4. Practical recommendations

1. Build a pre-import verification checklist (CE mark, Declaration of Conformity, identifiability of the manufacturer and EC REP, instructions for use and UDI) and retain the verification records.
2. Register the importer under Article 28 and obtain the SRN as a project start condition.
3. Agree in the commercial contract the deadlines for document supply and the handling of non-conforming cases (notify the manufacturer and the authorised representative).
4. Maintain a UDI ledger (Article 24(8)) consistent in scope with the manufacturer and distributor records.
5. Run an Article 16 assessment before executing any private-labelling, repackaging or instruction-amendment request.

5. Verification checklist

• □ CE mark and EU Declaration of Conformity verified as present
• □ Manufacturer verified as identifiable; authorised representative appointed for the non-EU manufacturer
• □ Instructions for use and UDI verified as supplied (applicable phase)
• □ Importer registered under Article 28 and SRN obtained
• □ UDI retention ledger established (Article 24(8))
• □ Article 16 assessment completed for private-labelling, repackaging and instruction-amendment requests

Legal information verified as of 2026-10-29.

GRZAN supports in vitro diagnostic manufacturers entering the EU market under Regulation (EU) 2017/746 as EU Authorised Representative (EC REP) and PRRC provider, including importer verification frameworks, Article 28 registration support, UDI traceability ledgers and fee budgeting for notified body and Member State charges. For importer-chain compliance, contact info@grzanglobal.com.