European Union · EU Authorized Representative (MDR)
EU Authorized Representative (MDR) for Non-EU Manufacturers
If your company is not established in the EU, you must appoint a sole EU Authorized Representative (EU AR) to place devices on the EU market. The EU AR accepts the mandate in writing, is listed on your labeling, and acts as your EU-based contact for authorities and documentation.
We act as your EU Authorized Representative so you can place medical devices on the EU market: a single, EU-based contact who accepts the mandate in writing, communicates with authorities, keeps documents available, and helps you meet registration and labeling expectations.
EU AR appointment (mandate in writing)
Authority communications & forwarding
Documentation availability for authorities
EUDAMED Actor/SRN guidance
A single EU contact for authorities, documentation, and labeling expectations.
- Appoint EU AR
- Register actors (EUDAMED/SRN)
- Keep docs available
- Handle authority communications & handover
What You Will Receive
The focus is simple: DI records entered into GUDID correctly and based on the data you provide.
EU AR mandate package
Formal appointment as your sole EU Authorized Representative: mandate text and acceptance in writing, plus a practical onboarding checklist so roles and responsibilities are clear from day one.
- Mapping of your existing UDI information (DI, issuing agency) to GUDID fields.
- Structuring basic device and packaging data (brand, model/version, packaging levels, key attributes) in a format GUDID expects.
- Short list back to you of any obvious gaps or inconsistencies to resolve before we enter the data.
Authority communications & documentation availability
A structured channel for authority communications: Sobel receives and forwards requests, coordinates responses with your team, and keeps technical documentation, EU declarations of conformity, and relevant certificates available to competent authorities when requested.
- Entry of your DI records into GUDID using the FDA web application and your account.
- Completion of required fields and key conditional elements, based on your instructions and supporting data.
- Basic on-screen checks so GUDID accepts the entries (no separate HL7 SPL build or automation).
EUDAMED Actor/SRN guidance & labeling support
Guidance for EUDAMED Actor registration and Single Registration Number (SRN) where applicable, alignment of contact details, and verification that your labeling shows the EU AR name and address when the manufacturer is outside the EU.
- A short note on when you should update a DI (e.g., label changes, packaging changes, discontinuation) vs. deactivate it.
- A basic checklist you can re-use when adding new DIs in the future.
Scope: EU Authorized Representative services only. We are not an importer, not a notified body, and do not provide legal representation or commercial distribution services.
Device records registered in EUDAMED using your own identifiers and data.
Label & IFU Confirmation
- Check that BRH identification appears correctly on labels and IFUs, as required.
- Support for electronic IFU portal upload where applicable.
- Basic alignment of regulatory text in labels/IFUs with the granted registrations/notifications.
Change & Revalidation Plan
- Categorize post-approval changes (approval-required, immediate implementation, non-reportable) under RDC 751/2022.
- Maintain a calendar and tracking logic for 10-year registration validity and revalidation.
- Outline a simple governance model so technical and commercial teams know when to involve the BRH.
Vigilance & Field Actions Routing
- Define who reports what, to whom, and when for Brazil-specific vigilance signals and field actions.
- Clarify timelines and roles for ANVISA notifications, customer communications, and follow-up reporting.
- Ensure vigilance documentation supports registration and labeling obligations.
How we work
We keep the process straightforward: prepare the data, enter it in GUDID, and hand back a clear overview.
Appoint & accept
- Confirm your GUDID account access (submitter/coordinator) and labeler role.
- Collect your UDI information (existing DI and issuing agency) and a product list with basic attributes and packaging levels.
Register the actors
- Map your UDI and product details into the GUDID data structure.
- Flag any missing essentials for you to confirm or correct.
Operate as your EU AR
- Log into your GUDID web account and enter DI records on your behalf.
- Complete required fields and save the entries so they appear in GUDID and AccessGUDID.
Maintain & hand over if needed
- Provide you with a simple list of DIs registered and key attributes entered.
- Share a short checklist for adding or updating DIs on your own going forward.
Label/IFU confirmation
Maintenance & vigilance
What We Need From You
We rely on you as the labeler for UDI choices and product facts; we handle the data entry.
- Company details and a clear device scope (device families, classes, and target markets in the EU).
- Company details and a clear device scope (device families, classes, and target markets in the EU).
- A regulatory point of contact for notices and authority questions.
- Access and information needed for EUDAMED Actor registration and SRN (where applicable).
- Current labeling samples and artwork references so we can verify that the EU AR name and address appear where required.
- High-level vigilance and field-safety contacts for escalation routes.
EU Authorized Representative service only. We are not your importer, not a notified body, and do not provide legal representation or commercial distribution. You remain responsible for manufacturing, quality, vigilance, and all direct interactions with notified bodies and customers.
Scope & Exclusions
We keep the service precisely defined so your internal team, Sobel, and your partners in Brazil understand who does what—and where additional services might be needed.
In Scope
- Consulting and documentation support for medical device market access and authorization in Brazil.
- Development of a Brazil-specific regulatory and market access strategy.
- Organization and structuring of a Brazil-ready documentation package based on your existing evidence.
- Alignment and regulatory review of core Portuguese label and IFU content.
- Coordination of roles and responsibilities with local Brazilian partners involved in regulatory processes.
Out of Scope
- Acting as a government authority or making regulatory decisions on behalf of ANVISA.
- Acting as your Brazilian Registration Holder (BRH) or equivalent local legal entity, unless contracted separately via a dedicated service.
- Laboratory testing or generation of new technical or clinical evidence.
- Full marketing translations, graphic label design, printing, and commercial artwork creation beyond regulatory text alignment.
Inputs We Need From Your Team
- Clear description of your devices, intended purpose, and key claims.
- Overview of models/variants and how you plan to position them in the Brazilian market.
- Available technical and regulatory documentation, including evidence and applied standards.
- Existing label and IFU content (or source text) to be aligned to Portuguese and to Brazilian expectations.
- Information on your current or planned local partners and legal representatives in Brazil.
- Internal timelines, priorities, and constraints for Brazil market entry.
Consulting and documentation support only. We do not design UDI schemes, do not create Annex VI data, do not select issuing agencies, and do not act as a notified body, importer, or label designer. You remain responsible for UDI assignment, Annex VI content, technical documentation, and all formal submissions in EUDAMED.
When You Need a Brazilian Registration Holder
Typical situations where appointing a BRH becomes essential for Brazil market access:
- You are a foreign medical device manufacturer without a Brazilian legal entity but want to place devices on the Brazilian market.
- You need a single, stable license holder that is not tied to any one distributor, so you can keep commercial options open.
- You want to file notifications/registrations under RDC 751/2022 and maintain them over time, including changes and revalidation.
- You need someone to be clearly identified on Brazilian labeling/IFU as the holder responsible before ANVISA.
- You want vigilance and field actions in Brazil to follow defined timelines and routing, without ad-hoc email chains.
FREQUENTLY ASKED QUESTIONS
Yes. If your company is not established in an EU Member State and you place medical devices on the EU market, you must appoint a sole EU Authorized Representative (EU AR) under MDR.
When the manufacturer is outside the EU, the label must show the EU AR’s name and address. We verify that your labeling reflects this and stays aligned with the mandate.
No. These roles are distinct under MDR. The EU AR is your mandated representative for specific regulatory responsibilities; the importer and notified body have separate duties. We act as EU AR only and do not take on importer or notified body roles.
EUDAMED Actor registration and SRN apply where relevant (including for authorized representatives). We guide you through the Actor module, the information needed, and how to keep actor details up to date.
Short Glossary
- Labeler: The party who assigns the UDI and whose name appears on the device label; responsible for GUDID entries.
- GUDID (Global UDI Database): FDA’s database that stores device identification data for devices with UDIs.
- DI (Device Identifier): The fixed part of the UDI that identifies the labeler and device model/version.
- PI (Production Identifier): The variable part of the UDI (e.g., lot, serial number, expiration date); GUDID only records which PIs are on the label, not the values.
- AccessGUDID: The public search interface that displays GUDID device records.
Appoint EU AR
We’ll reply with a proposed slot and a short intake checklist so we can confirm scope and start the mandate process.
Contact Us
We would love to speak with you.
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