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Buying a CE-marked medical device from outside the EU and reselling it here does not make you a passive middleman. Under the Medical Devices Regulation (EU) 2017/745 (MDR), the importer is an economic operator with its own legal obligations, set out in Article 13. If the manufacturer sits outside the EU, you are one of the first lines of defence the regulation relies on — and you carry liability. This article is the checklist of what you must verify and do before the device reaches the market, distinct from the Spanish AEMPS licensing route covered in our guide on importing medical devices into Spain.
Who is an “importer” under the MDR
An importer is any natural or legal person established in the EU that places a device from a third country on the EU market. The key word is places on the market: the moment a device from outside the Union is first made available here, an EU-established importer must be behind it. This is different from a distributor (who moves devices already on the EU market) and different from the manufacturer’s authorised representative. If your device is made outside the EU, someone has to be the importer of record — and that role has non-delegable duties.
What you must verify before importing (Article 13)
Before placing the device on the market, the importer must verify that:
- The device bears the CE marking and the manufacturer has drawn up the EU Declaration of Conformity.
- The manufacturer is identified and, being outside the EU, has designated an authorised representative under Article 11.
- The device is labelled in accordance with the MDR and accompanied by the instructions for use, in the language(s) required by the Member State.
- Where applicable, the manufacturer has assigned a Basic UDI-DI and UDI.
If you believe, or have reason to believe, that the device is not in conformity, you must not place it on the market until it is brought into conformity — and you must inform the manufacturer and, for a device presenting a risk, the competent authority.
What you must do once you are importing
- Add your details: indicate your name, registered trade name and address on the device, its packaging or an accompanying document.
- Register in EUDAMED: importers register to obtain a Single Registration Number (SRN) and are recorded against the devices they import, so the supply chain is traceable.
- Storage and transport: ensure conditions do not jeopardise conformity with the general safety and performance requirements (Annex I).
- Complaints and vigilance: keep a register of complaints, non-conforming devices, recalls and withdrawals, forward this information to the manufacturer and authorised representative, and cooperate on corrective actions.
- Records: keep a copy of the EU Declaration of Conformity and, where relevant, the certificate, available for the competent authorities.
Frequently asked questions
The device already has a CE mark. Is that enough for me to sell it?
No. CE marking is a manufacturer obligation; as importer you have your own verification and registration duties under Article 13. A CE mark that is present but unsupported by a valid Declaration of Conformity or a designated authorised representative does not make you compliant.
Can the manufacturer’s EU authorised representative act as importer?
They are separate roles with separate duties. One entity can, in some structures, hold more than one role, but the obligations of each role still apply in full and must be documented as such.
How ASC Services helps
We set up and run the importer role for you under the MDR: we verify CE marking, the EU Declaration of Conformity and the manufacturer’s authorised representative, check labelling, IFU and UDI, register you as importer in EUDAMED and obtain your SRN, and put in place the complaints, vigilance and record-keeping system Article 13 requires. Whether you import from Asia or the Americas, we make sure your position as importer of record is legally sound. Talk to us through our contact page or explore our consultancy services.