No EU representative, no EU market.
We become your EU Authorized Representative — and actually watch your compliance, not just hold your address.
Under MDR Article 11, a manufacturer with no EU place of business can place a device on the market only after appointing a single EC REP. MEDDEV takes on the mandate, registers your device in EUDAMED and keeps it audit-ready — usually starting the same week.
Built for quality manufacturers in the UK, Switzerland, USA, Japan, South Korea and the Gulf — an ongoing mandate, including devices up to Class III.
Left the EU system? You now need an EU representative.
Two of the strongest markets we serve are ones that used to be inside the EU framework and no longer are.
Post-Brexit, GB is a third country
A Great Britain manufacturer needs an EU Authorized Representative to keep placing devices on the EU market. A UK Responsible Person covers Great Britain only — it does not open the EU.
No more mutual recognition since May 2021
When the EU–Switzerland agreement lapsed, Swiss manufacturers became third-country for MDR. You now need an EU Authorized Representative — and an EU importer — to reach the EU market.
A mailbox gives you an address. We give you a representative who is accountable.
Most EC REP providers are a legal address that goes silent the moment an authority actually calls. Under MDR Article 11(5) your representative is jointly and severally liable for the device — so a passive mailbox is not a saving, it is exposure.
Everything Article 11 requires — as an outcome, not a task list
A legal EU market entry
Without an EU entity of your own — 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 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 later.
A rep who answers
When a competent authority requests documentation or samples, we respond the same working day — 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 authorities.
PRRC in the same hand
Need a Person Responsible for Regulatory Compliance (Article 15) too? We provide it under the same mandate.
We are selective — and that protects you too
Because an authorized representative is jointly and severally liable for the device under Article 11(5), we take on manufacturers we can stand behind. Our name on your label means a representative that has actually reviewed your file — which is exactly what your importer and the authorities expect. We represent higher-risk devices, up to Class III; we do not avoid them. Before any mandate we run a short eligibility and sanctions check — we cannot act for manufacturers in sanctioned jurisdictions.
A quality system in place
An ISO 13485 quality management system and technical documentation that meets MDR Annexes II and III.
Notified body where required
For Class IIa, IIb and III, a valid notified body certificate — the higher the class, the more we verify before we sign.
Liability defined up front
Product liability insurance from the manufacturer, with responsibilities and indemnity set out in the mandate.
Three steps to a compliant EU presence
Check eligibility
Send your device class and country of manufacture. 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
Do I actually need an EU Authorized Representative?
If you manufacture medical devices and have no registered place of business in the EU, MDR Article 11 makes it mandatory — without an EC REP your device cannot be placed on the EU market.
Is this not just a legal address I can buy for €150?
You can — until an authority calls and no one answers. Under MDR Article 11(5) your authorized representative is jointly and severally liable with the importer for defective devices, so a rep that never reviews your file 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.
Will my EU importer accept you?
Yes. Your importer can verify a valid, registered authorized representative with an SRN — exactly what they need before they distribute.
Can I switch from my current EC REP?
Yes. MDR allows changing representatives through a defined handover. We manage the transfer so there is no gap in your EU market access.
Does the CE mark help outside the EU?
Indirectly, yes. A CE mark and an audit-ready technical file strengthen and speed up submissions in markets that run their own review — for example the Gulf (Saudi SFDA, UAE). They do not replace local registration or a local representative there, but the same file we keep ready for the EU supports those applications.
Do you work in English?
Yes — the entire mandate, correspondence and reporting are handled in English.
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.