European Union · EU Authorized Representative Change (Article 12)
EU Authorized Representative (AR) Change — Article 12 Transfer Plan
Changing your EU Authorized Representative (AR) touches legal mandates, EUDAMED actor records, labeling, IFU, and complaint/vigilance flows. If dates and responsibilities are not clearly agreed, shipments, audits, and investigations can stall.
Change your EU Authorized Representative without disruption—Sobel documents the Article 12 transfer, aligns EUDAMED/SRN, and plans the necessary label/IFU updates so your market presence and audits stay on track.
Article 12 AR change planning
EUDAMED & SRN alignment
Label & IFU changeover
Distributor communication kit
Audit-ready transfer dossier
A documented AR changeover that authorities, NBs, and auditors can follow.
Get Your DI Records Properly Registered in GUDID
FDA’s Global UDI Database (GUDID) holds key device identification data for your products. As the labeler, you must register Device Identifier (DI) records that match what is on your labels and packaging. Those records are visible in AccessGUDID, so missing or incorrect data shows up publicly.
- GUDID stores the Device Identifier (DI) and key attributes; it does not store Production Identifier (PI) values, only whether PIs appear on the label.
- Labelers are responsible for submitting and maintaining DI records in GUDID.
- We use your existing DI values and product details and enter them in GUDID via your web account.
- You avoid wrestling with the interface and can show that your device data is registered and complete at the DI level.
What You Will Receive
The focus is simple: DI records entered into GUDID correctly and based on the data you provide.
Article 12 AR Change Agreement (draft)
Draft change agreement covering mandate end and start dates, last-use date of the old AR in information supplied by the manufacturer, document transfer and confidentiality, and post-mandate complaint forwarding in line with MDR Article 12.
- 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.
EUDAMED/SRN coordination pack
Actor-module checklist and practical notes to verify and align the manufacturer–AR link in EUDAMED, including evidence (screenshots or structured notes) that can be kept on file for audits.
- 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).
Label & IFU changeover plan
A pragmatic plan for where and how the new AR’s name and address must appear on labels and IFU for non-EU manufacturers, plus a controlled depletion approach for existing stock in line with MDR Annex I 23.2(d).
- 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.
Distributor communication kit
Short distributor and partner notices, key dates, and an internal FAQ so the supply chain understands when the new AR applies, how complaints are routed, and which materials must change.
- 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.
Transfer dossier
A consolidated transfer dossier including contacts, roles, escalation paths, vigilance handover notes, and proof of required notifications (e.g., outgoing AR notifications to competent authority and NB, where applicable under Article 11).
- 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.
Scope: Consulting and documentation only for AR change planning and evidence. Acting as the EU Authorized Representative is a separate service. No label artwork redesign beyond AR details, no translations, no printing or packaging execution.
How we work
We keep the process straightforward: prepare the data, enter it in GUDID, and hand back a clear overview.
Discovery & scope
- 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.
Set legal dates
- Map your UDI and product details into the GUDID data structure.
- Flag any missing essentials for you to confirm or correct.
Handover package
- 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.
EUDAMED / SRN coordination
- 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 updates
- 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.
- Manufacturer legal details and SRN (if already issued), plus primary regulatory and operations contacts.
- Current AR mandate, contact details, and any existing change or termination notices.
- Notified body involvement and certificates that reference the AR or address details.
- Packaging and IFU inventory overview: SKUs, where AR details appear, and stock realities.
- Distributor and key partner list for change notifications and timing alignment.
Consulting and documentation for EU AR change planning only. Acting as the EU Authorized Representative is a separate service. We do not redesign label artwork beyond AR details, do not provide translations, and do not execute printing or packaging changes. You remain responsible for final decisions, contracts, and formal notifications to authorities and notified bodies.
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. MDR Article 12 requires an agreement between the manufacturer and the new AR, and—where practicable—the outgoing AR, covering dates, document transfer, last use of the old AR on materials, and complaint forwarding. We draft this as part of the change package.
For non-EU manufacturers, labels and IFU must show the EU Authorized Representative’s name and address. When the AR changes, this must be reflected with a controlled changeover on labels, IFU, and related materials in line with MDR Annex I 23.2(d).
If the outgoing AR terminates its mandate, it must inform its competent authority and, where applicable, the notified body in accordance with MDR Article 11. We include the relevant notices and evidence in your transfer plan and dossier.
Typical projects complete in about 2–6 weeks, depending on how quickly the change agreement is signed, EUDAMED records are updated, and label/IFU changes are implemented. This is an operational estimate, not a guarantee.
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.
Request AR transfer plan
We’ll reply with a proposed slot and a short intake checklist so we can confirm your current AR setup, scope, and timelines.
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