EUDAMED-registered
MD QMS SRL is registered as an economic operator in EUDAMED: a precondition for acting as your importer, and for the Authorised Representative role we are bringing online next.
Registered in EUDAMED
The threshold between your device and the EU market.
For manufacturers outside the EU, the Single Market has a doorway — and someone has to stand in it. MD QMS SRL is your EU-based importer, registered in EUDAMED and built inside an established medical-device quality and compliance practice. Our EU Authorised Representative service is in development and will launch soon.
Why a manufacturer hands us this responsibility
A practitioner, not a mailbox
This isn’t a registered address that forwards post. MD QMS SRL is run by named medical-device quality and regulatory practitioners: ISO 13485, ISO/IEC 27001 and MDR work, hands on.
Part of the MD QMS family
MD QMS SRL sits alongside an established UK compliance and technology consultancy. The importer role, and the representative role once it launches, is backed by the people who do the underlying QMS and regulatory work.
Two roles, kept distinct
A manufacturer outside the EU needs an EU Authorised Representative. Someone established in the EU also has to act as importer when devices are placed on the market. We hold the importer role now and are bringing the representative role online next, kept distinct because they answer to different obligations.
Coming soon
EU Authorised Representative
Your legal point of presence in the Union: named on your documentation and acting as your contact for EU competent authorities, under a written mandate.
About the AR role → LiveImporter
The EU-established operator that places your device on the market. Before a product crosses the threshold, an importer has to verify that conformity, marking and registration are in order. That verification is the job.
How the importer role works →Where each role sits
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
- Manufacturer (outside the EU)
- EU Authorised Representative
- EU competent authorities
Written mandate. Documentation, registration and authority requests.
Supply chain
- Manufacturer (outside the EU)
- Importer (EU)
- Distributor
- Hospitals and users
Verification before placing on the market, traceability after.
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 importer we have to verify that registration, so we check it with you first.
Leadership
The people behind the mandate
MD QMS SRL is run by named practitioners, not a registered address. Here is who 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 applies to keeping MD QMS SRL’s import records and client communications organised and audit-ready.
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 MD QMS SRL’s 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 importer role, and the Authorised Representative role in development.
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 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.