Role 02
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 genuinely 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. We confirm the device-side prerequisites are in order before placing a product on the market, identify ourselves on the relevant documentation, and keep the records that let us — and the authorities — trace what we placed and when.
What we verify before placing a device
- That the device bears CE marking and that the required conformity steps appear to have been completed.
- That an EU Authorised Representative has been designated where the manufacturer is outside the EU.
- That the labelling and instructions for use meet the requirements for the markets you’re selling into.
- That the device is, or can be, properly identified and registered in EUDAMED.
- Keeping a register of complaints, non-conforming devices, and any recalls or withdrawals we’re involved in.
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.