EUDAMED-registered
MD QMS SRL is registered in EUDAMED as an economic operator, which it has to be before it can act as your regulatory importer.
Registered in EUDAMED
Your independent EU regulatory importer for medical devices.
MD QMS SRL acts as EU regulatory importer for medical device manufacturers based outside the EU. We’re a Romanian company registered in EUDAMED, and the people who run it also do ISO 13485 and MDR quality work.
Fixed annual fee, quoted within 48 hours of complete information. You work with the named people on this site, and we reply to messages within two working days.
LiveRegulatory importer EUDAMEDEUDAMED-registered economic operator · SRN RO-IM-000056427
Why a manufacturer hands us this responsibility
A practitioner, not a mailbox
We’re not a registered address that forwards post. MD QMS SRL is run by named people who do medical device quality and regulatory work every day, across ISO 13485, ISO/IEC 27001 and the MDR.
Part of the MD QMS family
MD QMS SRL works alongside an established UK compliance and technology consultancy. The people behind the regulatory importer role also do the underlying QMS and regulatory work.
What does an EU regulatory importer do?
Devices made outside the EU need an EU-established regulatory importer before they reach EU customers. We take on that role for you: we check your devices before they go on the market and keep the traceability records afterwards.
The regulatory importer is the EU-established company that takes on the MDR Article 13 obligations for devices made outside the EU. Before devices reach the market, it checks that they are CE marked, correctly labelled and registered, and it keeps records that let authorities trace what was supplied and when.
Under MDR Article 13(3), our name, registered trade name or trade mark, registered place of business and contact address go on the device, its packaging or a document that comes with it. Anything we add must not cover the information on your own label. We agree with you which option suits your device and packaging.
Where the regulatory importer sits
The regulatory importer sits between you and your EU distributors and customers. How it fits into each route to market is agreed before we start.
Supply chain
- Manufacturer (outside the EU)
- Regulatory importer (EU)
- Distributor
- Hospitals and users
Verification before placing on the market, traceability after.
One regulatory importer, multiple distributors
When each EU distributor imports your devices itself, each one’s details go on your labelling and each keeps its own records. Three distributors can mean three sets of details to print, stock and keep up to date.
With one regulatory importer across your distributors:
One regulatory importer, multiple distributors
the same regulatory importer details on devices supplied through the arrangement, whichever distributor sells them.
One set of records
complaints, non-conformities, recalls and withdrawals sit in one register.
Roles agreed up front
we map how each distributor is supplied before we start, so everyone knows which role they hold.
Do you need an EU regulatory importer?
It depends on how your devices reach the EU. These are the three set-ups we see most often.
You sell directly to EU hospitals or customers, with no EU distributor importing for you.
You need an EU importer.
You work with several EU distributors and want one consistent regulatory importer.
One regulatory importer keeps the checks and records in one place. We look at how each distributor is supplied before we take it on.
Your EU distributor buys your devices directly and brings them in.
Your distributor usually acts as importer for the devices it buys directly. If you sell through more than one, a single regulatory importer gives you one point of contact in the EU for authorities, complaints and recalls, one set of checks and records, and the same importer details on devices supplied through it. We’ll tell you plainly if you don’t need us.
What we verify and keep
- That the device is CE marked and its EU declaration of conformity has been drawn up.
- That the manufacturer is identified and has designated an EU Authorised Representative.
- That the device is labelled and accompanied by the required instructions for use.
- That a UDI has been assigned by the manufacturer, where applicable.
- That the device is registered in EUDAMED, adding our details to that registration.
- That storage and transport conditions under our responsibility don’t compromise the device.
- A register of complaints, non-conforming devices, recalls and withdrawals.
- Forwarding complaints and suspected-incident reports to the manufacturer and its Authorised Representative without delay.
- Copies of the EU declaration of conformity and relevant certificates, kept for the period the MDR requires.
How it works
- 01
Send us your device details
Your device list and classes, EU declarations of conformity and certificates, EUDAMED status (SRN and UDI data), and how your devices reach EU customers.
- 02
Get a fixed annual quote
We confirm whether we can act as your regulatory importer and send a quote within 48 hours of receiving complete information.
- 03
Checks before the first shipment
We run the Article 13(2) checks, add our details to your EUDAMED registration and agree where our name and address go. Nothing goes on the market until the checks are done.
- 04
Records for as long as the MDR requires
We keep the register of complaints, non-conforming devices, recalls and withdrawals. You and your distributors can ask us for information from it at any time.
Deadline Read the guide →
EUDAMED: 28 November 2026
Devices placed on the market before 28 May 2026 and still being made available must be registered in EUDAMED’s UDI/Device module by 28 November 2026. As your regulatory importer we have to verify that registration, so we check it with you first.
Not sure your EUDAMED set-up is right?
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.
Leadership
The people behind the regulatory importer role
These are the people you would actually work with.
Andreea Moruz
Managing Director, MD QMS SRL
Andreea leads MD QMS SRL’s day-to-day operations, coordination and client relationships. She is a qualified medical assistant, practising in family medicine, and has trained as an instructor for the European Resuscitation Council: a clinical, patient-facing perspective on how device documentation and compliance paperwork hold up in real use.
Her earlier experience spans public procurement, supplier and customer coordination, and operational reporting, which she uses to keep MD QMS SRL’s regulatory importer records and client communications organised and ready for audit.
View LinkedIn profile →
Mirela Adamovici
Senior Compliance Consultant, MD QMS SRL
Mirela is a regulatory compliance specialist with hands-on knowledge of GMP, ISO 13485, ISO 14971, ISO 9001, MDR, EUDAMED and FDA 21 CFR Part 820. She has implemented and maintained quality management systems from the ground up, led ISO certification programmes, and works as a qualified internal auditor.
She also brings a strong procurement and logistics background (supplier qualification, import/export operations, customs compliance and international shipping): the operational grounding behind the verification work the regulatory importer role requires.
View LinkedIn profile →
Alex Adamovici
Senior Consultant, MD QMS SRL
Alex covers MD QMS SRL’s technical and governance side, with a security-first background spanning cloud architecture, identity and access management, and infrastructure engineering across regulated industries. He is an ISO/IEC 27001:2022 Lead Auditor and holds a certification in ISO 14971 medical device risk management.
His career has been built across cloud infrastructure, identity engineering, and release and risk governance in regulated environments: the systems discipline behind how MD QMS SRL documents and governs its regulatory importer role.
View LinkedIn profile →The MD QMS family
MD QMS SRL is the EU market-access arm of a wider quality, regulatory and technology practice. If you need the underlying QMS, regulatory strategy or cybersecurity work, our UK sister company MD QMS Ltd. provides it, with the roles kept separate.
Need an EU regulatory importer you can actually reach?
Tell us what you make and where you sell. We’ll tell you plainly whether you need a regulatory importer, and what it costs.