FDA clearance won't get you into Europe.
Selling in the EU needs CE marking under MDR — and a single EU Authorized Representative. We become yours, and actually watch your compliance.
If you manufacture in the US with no EU place of business, MDR Article 11 requires a designated EC REP before your device can reach the EU market. MEDDEV takes on the mandate, registers your device in EUDAMED and keeps it audit-ready — usually starting the same week.
Built for US manufacturers placing a device on the EU market for the first time.
Two markets, two systems — and Europe needs a representative.
FDA clearance or approval covers the United States. To place the same device on the EU market you need conformity with MDR 2017/745, the CE mark, and — because you have no EU establishment — a single EU Authorized Representative under Article 11. Your EU importer is legally required to verify that representative, with an SRN, before they distribute. Skipping it doesn't slow the launch — it stops it.
Everything Article 11 requires — as an outcome, not a task list
A legal route into the EU
Without opening an EU entity — we take on the mandate so your device can be placed on the EU market under MDR Article 11.
Your SRN, handled
We register you and every device in EUDAMED and obtain the Single Registration Number your EU importer needs before they distribute.
Label-ready compliance
Your device carries a valid EU representative name and address, exactly as MDR Annex I requires — no relabelling scramble at the border.
A rep who answers your timezone
When a competent authority requests documentation or samples, we respond the same working day, in English — not a mailbox that goes silent.
Vigilance & FSCA covered
We forward and act on incidents, complaints and field safety corrective actions between you and the EU authorities.
PRRC in the same hand
Need a Person Responsible for Regulatory Compliance (Article 15) too? We provide it under the same mandate.
Three steps to a compliant EU presence
Check eligibility
Send your device class and where it is manufactured. Same working day, we confirm whether you need an EC REP and what the mandate covers — free, no obligation.
Mandate & registration
We sign the EC REP mandate, register you and your devices in EUDAMED, and update your labelling and technical file.
Ongoing oversight
We act as your EU contact point and keep the device audit-ready — its supervision status stays publicly verifiable.
EU Authorized Representative — the essentials
We are FDA-cleared — isn’t that enough for the EU?
No. FDA clearance or approval covers the US market only. To sell in Europe your device must conform to EU MDR 2017/745, carry the CE mark, and — because you have no EU place of business — have a designated EU Authorized Representative under Article 11. They are separate regulatory systems.
Do I actually need an EU Authorized Representative?
If you manufacture medical devices in the US (or anywhere outside the EU) and have no registered EU place of business, MDR Article 11 makes an EC REP mandatory — without one your device cannot be placed on the EU market.
Can’t my EU distributor just handle this?
No. Your importer and distributor have their own obligations, but the law requires a separately designated authorized representative. In fact your EU importer must verify a valid EC REP with an SRN before they distribute.
Is this not just a legal address I can buy for a few hundred dollars?
You can — until an authority calls and no one answers. Under MDR Article 11(5) your representative is jointly and severally liable with the importer for defective devices, so a passive mailbox is not a saving, it is exposure. We pair the mandate with active file review and a publicly verifiable supervision status.
How fast can I be on the EU market?
Send the device, class and documentation and we confirm scope the same working day. Mandate signing and EUDAMED registration follow immediately.
Do you work in English?
Yes — the entire mandate, correspondence and reporting are handled in English, on your timezone as far as a working day allows.
Get your EU Authorized Representative in place
The fastest route is the eligibility check above. Prefer to write directly? Email us and we usually reply the same working day.