For US medical device and IVD manufacturers · MDR / IVDR Article 11
EU Authorized Representative for US medical device manufacturers.
Selling in the EU needs CE marking under MDR — and a single EU Authorized Representative with a defined regulatory role.
If you manufacture in the US with no EU place of business, Article 11 of the MDR or IVDR requires a designated EC REP before the device can reach the EU market. MEDDEV accepts the mandate after a file and liability review, then coordinates the required EUDAMED work and ongoing representation.
For US manufacturers entering the EU market or changing their current EC REP.
Online intake Secure connection MEDDEV brand serving medical-device companies since 2012 MDR 2017/745 & IVDR 2017/746 Documentation reviewed before mandate
Manufacturers who have worked with MEDDEV
MEDDEV Safety Signals · Issues 01–02
2 reports View the series → Source-backed safety reports covering Europe and the United States.
From US evidence to an EU file
One device. A separate European regulatory path.
US clearance can support the evidence review, but it does not replace the MDR or IVDR conformity route. We define the EU file, representative mandate, registration responsibilities and label changes as one controlled workstream.
US evidence mapped to EU requirementsDefined scope
FDA status and device identityMapped to the EU file
MDR or IVDR conformity routeAssessed separately
Annex II and III documentationGaps recorded
EU labelling and EUDAMED dutiesOwners defined
Existing US evidence is used where relevant; it is not presented as an EU approval.
FDA is not CE
US clearance and EU market access follow separate rules.
FDA clearance or approval covers the United States. To place the same device on the EU market, the manufacturer must follow the applicable MDR or IVDR conformity route and appoint a single EU Authorized Representative if it has no EU establishment. Before placing the device on the market, the importer must verify that appointment and the applicable registration obligations.
When it matters
Administrative-only scope
MEDDEV active scope
When an authority requests documents
Passes the request to the manufacturer
Works from a file reviewed before the mandate and coordinates the response
During a vigilance case or FSCA
Provides the required contact point
Coordinates communication while the manufacturer investigates and decides corrective action
Technical documentation & labelling
Checks the appointment details
Reviews the agreed file scope and EC REP labelling before the mandate starts
EUDAMED registration
Leaves entries to separate providers
Coordinates actor and device entries with responsibilities defined in writing
Evidence for your EU importer
Provides appointment details
Provides verifiable registration and a clearly documented service scope
Public-market signal check: where relevant, we review available product listings, store or app-market feedback, recalls and other public safety signals. Customer reviews are treated as leads for verification against complaints, vigilance records and technical documentation — never as verified facts on their own.
Briefings
What US manufacturers ask before the first call
Each briefing states the provision behind the answer and links to the official text. Start with the hub if the device has no European history yet.
From FDA clearance to CE marking
What a US file can be reused for, what has to be produced again, and which steps require an address inside the Union.
EUDAMED: what falls due by 27 November 2026
Which modules became mandatory, what the twelve-month obligation covers, and why a single registration number cannot be obtained alone.
QMSR compliance and MDR conformity
The FDA now incorporates ISO 13485:2016 by reference. The processes the Regulation still adds on top.
What a 510(k) is worth under Article 61
A predicate is not an equivalent device. What carries across, and what has to be generated first.
Sterile devices and the European evidence
Sterility assurance, ethylene oxide residues, packaging validation, and why class I sterile still needs a notified body.
CRA reporting from 11 September 2026
The device exemption does not reach the portal, the companion software without a medical purpose or the tools shipped around it.
What you get
The mandate, registration and ongoing regulatory contact
A legal route into the EU
Without opening an EU entity — we take on the mandate required by Article 11 of the MDR or IVDR.
EUDAMED registration coordinated
Four modules — actor registration, UDI/Devices, notified bodies and certificates, and market surveillance — have been mandatory since 28 May 2026 under Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860. For devices already on the market, Regulation (EU) 2024/1860 allows no later than twelve months from publication of the Commission notice, published on 27 November 2025. We coordinate actor registration, the SRN process and required device entries. The manufacturer remains responsible for the accuracy of its device data.
Label-ready compliance
Your device carries the EU representative name and address required by the applicable MDR or IVDR labelling rules — no relabelling scramble at the border.
A defined authority-response process
Requests for documentation or samples are assessed and coordinated without losing time on finding the responsible person.
Vigilance communication coordinated
We forward complaints and incident reports and coordinate communication with authorities. Investigation and corrective decisions remain with the manufacturer.
PRRC arranged where permitted
A separate PRRC arrangement is available for eligible micro and small manufacturers. MEDDEV also maintains the PRRC capacity required of an authorized representative.
How it works
How we start and maintain the mandate
01
Check eligibility
Send your device class and where it is manufactured. We confirm whether an EC REP is required and define the document review needed before a mandate.
02
File review & mandate
We review the agreed documentation, define responsibilities and sign the mandate only when the acceptance criteria are met.
03
Registration & ongoing representation
We coordinate EUDAMED entries, verify EC REP labelling and act as the defined EU contact throughout the mandate.
Questions from US manufacturers
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 the European Union, the device must follow the applicable MDR or IVDR conformity route and — because you have no EU place of business — have a designated EU Authorized Representative.
Do I actually need an EU Authorized Representative?
If you manufacture medical devices or IVDs in the US and have no registered EU place of business, Article 11 of the MDR or IVDR requires an authorized representative before the device can be placed on the EU market.
Can’t my EU distributor just handle this?
No. Importers and distributors have their own obligations, but they do not replace the authorized representative. Before placing the device on the market, the importer must verify that the manufacturer has appointed one and met the applicable registration obligations.
Is an EC REP only a legal address?
No. Article 11 of the MDR and IVDR assigns defined verification, record-keeping, communication and cooperation duties to the authorized representative. Article 11(5) can also create joint and several liability with the manufacturer when its conditions are met. That is why every MEDDEV mandate begins with a file and liability review.
How quickly can the mandate start?
We normally confirm eligibility and the review scope on the same working day. The mandate starts after the required documentation, insurance and screening checks are complete; timing therefore depends on file readiness.
Can the same representative support access to Türkiye?
Under the EU–Türkiye Customs Union arrangements, a US manufacturer can designate one authorized representative established either in the EU or in Türkiye for access to those markets. The applicable registration, documentation and labelling still need to be planned for the intended markets.
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.
Talk to us — in English
Ask about an EC REP mandate
The fastest route is the eligibility check above. Prefer to write directly? Email us and we usually reply the same working day.
MEDDEV Compliance sp. z o.o. EU-established company · Warsaw, Poland ul. Mydlarska 47, 04-690 Warszawa biuro@meddev.pl