Our services
MD QMS SRL holds the importer role today and is bringing the EU Authorised Representative role online next. Here is what each role does, and which one you need.
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.
This service is not yet open for mandates.
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.
You manufacture outside the EU and sell devices into the EU.
EU AR You need an EU Authorised Representative.
You sell directly to EU hospitals or customers, with no EU distributor importing for you.
Importer You need an EU importer.
Your EU distributor buys and brings in your devices.
EU AR Your distributor usually acts as importer. You still need an Authorised Representative.
You work with several EU distributors and want one consistent importer.
Importer A neutral importer can keep verification and records in one place.
The Authorised Representative is not a step in your supply chain. It represents you towards the authorities, while the importer is part of the chain that physically brings devices into the EU.
Legal representation
Written mandate. Documentation, registration and authority requests.
Supply chain
Verification before placing on the market, traceability after.
Our UK sister company MD QMS Ltd. runs a fixed-price EUDAMED and EU market-access check: actor registration, UDI data and who holds which economic-operator role for your devices.
Tell us what you make and where you’re selling. We’ll tell you plainly which role applies to you and what it costs.