European Union · EUDAMED Device Registration
EUDAMED Device Registration — UDI/Devices Entries Built from Your Data
EUDAMED’s UDI/Devices module holds core identification data for your devices in the EU, tied to the UDI system. Those records must reflect the Annex VI data your organisation maintains and stay consistent with your technical documentation and labels.
We prepare and register your device data in EUDAMED (UDI/Devices module), using the UDI identifiers and Annex VI data you already manage, so your EU records are accurate, consistent, and easy to maintain—without designing UDI structures or creating Annex VI content.
UDI/Devices data entry support
Use of your existing Annex VI data
SRN & Actor alignment
Simple maintenance plan
Device records registered in EUDAMED using your own identifiers and data.
What You Will Receive
Our BRH service is focused on being your legal license holder in Brazil and keeping all regulatory obligations organized under RDC 751/2022.
EUDAMED device record preparation
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- Appointment letter and powers of attorney needed to formalize Sobel as your Brazilian Registration Holder.
- Clear contact points for operational, regulatory, and vigilance topics.
- Escalation paths for urgent ANVISA interactions or field actions.
Field mapping overview & checklist
A concise overview and checklist showing how your existing Annex VI data and labels map into the UDI/Devices fields (based on what you already maintain). We do not create new Annex VI content; we help you apply the data you already have in the right places.
- Applicant and product forms prepared in line with RDC 751/2022 requirements.
- Intake and review of technical dossier elements (device description, risk class, safety and performance evidence).
- Confirmation when a Brazilian GMP certificate is required for specific registration paths, based on device class and route.
Maintenance guide
A practical maintenance guide that explains what typically triggers updates vs. deactivation and how to keep your EUDAMED device entries aligned with changes you make in your own Annex VI data and technical documentation.
- Submission of Class I–II notifications and Class III–IV registrations to ANVISA.
- Coordination of fee payments, response to basic ANVISA process queries, and tracking of status.
- Capture and organization of grant/publication evidence for internal and external stakeholders.
Scope: Data preparation and registration support only. We do not design your UDI structure, do not create or interpret Annex VI data for you, do not select issuing agencies, and do not act as a notified body, importer, or label designer. All core Annex VI content and identifiers come from your organisation.
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
A clear operational model so you know how Sobel acts as your Brazilian Registration Holder from first contact through long-term maintenance.
Confirm actors & SRN
Collect identifiers & Annex VI data
Prepare UDI/Devices entries
Register & maintain
Label/IFU confirmation
Maintenance & vigilance
What we need from you
To keep roles clear, we distinguish precisely what is in scope for the BRH service and what is not.
In Scope
- BRH representation before ANVISA for medical devices.
- Notifications and registrations under RDC 751/2022, including changes and revalidation planning.
- Labeling and IFU identification checks to ensure BRH details are correctly presented.
- Planning and categorization of post-approval changes (approval-required, immediate implementation, non-reportable).
- Routing of vigilance and field actions to meet ANVISA notification expectations.
Out of Scope
- Laboratory testing or performance/biocompatibility studies.
- Label artwork design, printing, or packaging production.
- Full marketing translations beyond inserting required regulatory wording.
- Commercial distribution or acting as a sales/distribution entity in Brazil.
Inputs We Need From Your Team
- SRN and Actor registration status, plus confirmation of who operates your EUDAMED account.
- Existing UDI identifiers: Basic UDI-DI, UDI-DI, UDI-PI (as you already define and use them).
- Your existing Annex VI core data for each device and packaging configuration (we do not create or interpret it from scratch).
- A device and packaging list that shows models, variants, and how they group under Basic UDI-DIs.
- Relevant excerpts from technical documentation and label samples so we can check consistency between your data, labels, and UDI/Devices entries.
- A regulatory/quality contact empowered to clarify data and approve changes.
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. You first complete Actor registration and obtain a Single Registration Number (SRN). Once that is in place, you or your economic operator can submit UDI/Devices entries for your portfolio.
No. We rely entirely on the UDI identifiers and Annex VI data you already manage. We do not design UDI structures, do not choose issuing agencies, and do not create or interpret Annex VI content. Our role is to help you apply your existing data correctly in EUDAMED.
Mandatory use of each EUDAMED module starts after the European Commission declares that module fully functional and publishes a notice. We align our work to the current status at the time of the project and to your specific obligations.
Yes. For non-EU manufacturers, we work with the relevant EU economic operator (such as the authorised representative or manufacturer within the EU) so that device entries are submitted under the correct Actor profile and SRN using your existing data.
No. We act as the Brazilian Registration Holder for regulatory purposes. Commercial distribution remains with your chosen partners, which can change without changing the BRH.
Yes. We help categorize post-approval changes under RDC 751/2022, manage the required filings, and maintain a clear record for audits and inspections.
Register in EUDAMED
We’ll reply with a proposed slot and a short intake checklist so we can confirm your SRN, current data structure, and device scope.
Contact Us
We would love to speak with you.
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