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Importer
An importer is the EU-established operator that places a device from a non-EU manufacturer on the Union market. Before that happens, someone has to check that the device is ready to cross the threshold. We do that checking, and we keep the records that prove it.
What an importer does
The importer sits in the commercial supply chain, but the role carries verification duties, not just logistics. Under the MDR, an importer may only place devices on the market that conform to the Regulation. We verify the device-side prerequisites before placing a product on the market, identify ourselves on the device or its packaging, and keep the records that let us, and the authorities, trace what we placed and when.
What we verify and keep
- That the device is CE marked and its EU declaration of conformity has been drawn up.
- That the manufacturer is identified and has designated an EU Authorised Representative.
- That the device is labelled and accompanied by the required instructions for use.
- That a UDI has been assigned by the manufacturer, where applicable.
- That the device is registered in EUDAMED, adding our details to that registration.
- That storage and transport conditions under our responsibility don’t compromise the device.
- A register of complaints, non-conforming devices, recalls and withdrawals.
- Forwarding complaints and suspected-incident reports to the manufacturer and its Authorised Representative without delay.
- Copies of the EU declaration of conformity and relevant certificates, kept for the period the MDR requires.
Importer and representative are not the same job
We act as your importer today. Our Authorised Representative service is in development and will sit alongside it once live, but we keep the two distinct rather than collapsing them into one vague “EU partner” offer. If holding both roles for your devices would raise a conflict in your situation, we’ll say so.
EU Authorised Representative
Your legal point of presence in the Union: named on your documentation and acting as your contact for EU competent authorities, under a written mandate.
About the AR role →Need an EU importer you can actually reach?
Tell us what you make and where you’re selling. We’ll tell you plainly whether we can help and what it costs, and let you know the moment our Authorised Representative service opens.