FAQ
Questions manufacturers ask us
Straight answers about the Authorised Representative and importer roles, EUDAMED and working with us.
What’s the difference between an Authorised Representative, an importer and a distributor?
The Authorised Representative is the non-EU manufacturer’s legal representative in the EU, acting under a written mandate and dealing with competent authorities. The importer is the EU-established operator that places a device from outside the EU on the market, after verifying it is compliant. A distributor makes devices available further down the supply chain, after verifying the basics such as CE marking and labelling. One company can hold more than one role, but each comes with its own obligations.
Can you act as both our importer and our Authorised Representative?
The MDR allows it. Our AR service isn’t open yet, and when it is we’ll assess each case: if holding both roles for your devices would create a conflict in your supply chain, we’ll tell you plainly.
How does switching Authorised Representative work?
Article 12 of the MDR requires an agreement between the manufacturer, the outgoing AR and, where practicable, the incoming AR. It must cover the dates the mandates end and begin, until when the old AR may still appear on your information, the transfer of documents, and the forwarding of complaints and incident reports. Our switching guide walks through the steps.
What do you need from us to get started?
Your device list and classes, your EU declarations of conformity and certificates, access to your technical documentation, your EUDAMED status (SRN and UDI data), and a description of how devices reach EU customers. From that we confirm which role we can take on and quote.
What does it cost?
We charge a fixed annual fee based on the role, the number of device families and their classes. We quote within 48 hours of receiving complete information, with no hourly billing.
Why a Romanian company?
The MDR requires your Authorised Representative and importer to be established in the EU, not in any particular Member State. Being Romania-based also gives you native-language support for Romanian and Central and Eastern European markets.
Do we have to do anything about EUDAMED before 28 November 2026?
If you have devices placed on the market before 28 May 2026 that are still being made available, they must be registered in EUDAMED’s UDI/Device module by 28 November 2026. Devices placed on the market from 28 May 2026 must be registered before they are placed. Our EUDAMED guide explains what applies to you.
Who are your UK sister company and what do they do?
MD QMS Ltd. is a UK consultancy providing ISO 13485, MDR, FDA and cybersecurity services. It is a separate company. We keep the consultancy and economic-operator roles distinct, and our verification as importer is independent of any consultancy work.
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.