Our services
Two roles. One EU gateway.
MD QMS SRL holds the importer role today and is bringing the EU Authorised Representative role online next. Jump to the one you need, or read both.
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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 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.
Coming soon
EU Authorised Representative
If you manufacture a medical device outside the EU and want to place it on the Union market, you need an Authorised Representative established in the EU. MD QMS SRL is bringing this service online — it is in development and not yet open for mandates.
What an Authorised Representative is
The Authorised Representative is the manufacturer’s legal presence inside the EU, identified on your documentation and acting as the point of contact between your company and EU competent authorities. The relationship is governed by a written mandate that sets out, precisely, the tasks you delegate and the ones you keep. We are setting up this service now, ahead of accepting mandates.
What the role will cover, once live
- Acting as your named EU point of contact for competent authorities.
- Holding and making available the technical documentation we are mandated to keep available.
- Cooperating with authorities on any preventive or corrective action concerning your devices.
- Forwarding requests for samples, information, or access that authorities direct to us.
- Maintaining our registration as an economic operator in EUDAMED in connection with your devices.
Not sure which role you need?
Tell us what you make and where you’re selling. We’ll tell you plainly which role applies to you and what it costs.