Questions manufacturers ask us

The regulatory importer is the EU-established operator that takes on the MDR Article 13 checks for devices coming from outside the EU, before they reach the market. A distributor makes devices available further down the supply chain and checks the basics, such as CE marking, labelling and the regulatory importer’s details. The two roles carry different obligations, and which one a company holds depends on how it obtains the devices.

Often, yes. It depends on how your devices are supplied to each distributor, so we map your routes to market before we agree anything. Where a distributor buys directly from you and brings the devices in itself, it normally takes on that role for those devices.

No. We don’t run a warehouse, and devices can go straight to your distributors or logistics provider. How supply and paperwork work for your devices is set out in our agreement with you.

Customs and VAT are separate from the MDR. Who acts as customs declarant and pays import VAT is agreed for each route, usually with your logistics provider or customs broker. We ask about it early so the paperwork lines up.

Yes. Under MDR Article 11, every manufacturer outside the EU needs one, and it’s a separate role. We don’t act as Authorised Representative at the moment. You can look up registered Authorised Representatives in EUDAMED’s public actor search, and we check that yours is designated and registered before we start.

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 whether we can act as your regulatory importer, and quote.

A fixed annual fee based on the number of device families and their classes. We quote within 48 hours of receiving complete information, with no hourly billing.

The Article 13 checks before devices reach the market, adding our details to your EUDAMED registration, reviewing how our details appear on your labelling, the complaints, non-conformity, recall and withdrawal registers, and routine contact with you, your Authorised Representative and the authorities. Bigger pieces of work, such as extra device families, artwork redesign or support through a large recall, are quoted separately.

The MDR requires your regulatory importer to be established in the EU, not in any particular Member State. Being in Romania also gives you Romanian-language support and knowledge of the Romanian and wider Central and Eastern European market.

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.

MD QMS Ltd. is a separate UK consultancy providing ISO 13485, MDR, FDA and cybersecurity services. If MD QMS Ltd. has worked on your device, our regulatory importer checks are carried out and signed off by someone who wasn’t involved, and we tell you about it in writing. If we can’t keep that separation, we don’t take on the role.