European Union · CE Marking under MDR
EU CE Marking (MDR) — Complete Technical Documentation
Under the EU Medical Device Regulation (MDR), you must build and maintain Technical Documentation (TD) that shows conformity with Annex I and supports the chosen conformity assessment route. Notified Bodies review this file set against Annex II and expect clear, consistent traceability.
We assemble and author your Technical Documentation to Annex II and build a clause-by-clause GSPR matrix for Annex I, so requirements, evidence, and rationales line up cleanly.
The result is a defendable, inspection-grade Technical Documentation set—structured exactly to Annex II and cross-referenced to Annex I GSPRs—that enables fast, low-friction Notified Body review.
Full TD authoring (Annex II)
GSPR matrix (Annex I)
Traceability & cross-references
NB submission readiness
A single, inspection-grade file set that Notified Bodies can navigate quickly.
What You Will Receive
The focus is simple: DI records entered into GUDID correctly and based on the data you provide.
Complete TD (Annex II)
Complete Technical Documentation structured to Annex II: device description, design and manufacturing, verification and validation, usability, software (if applicable), sterilization, biocompatibility, and curated cross-references to clinical and risk evidence—with a consistent hyperlink structure.
- 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.
GSPR Mapping (Annex I)
A clause-by-clause GSPR matrix for Annex I: applicability per requirement, evidence/reference, concise rationale, and justified non-applicable (NA) decisions, giving Notified Bodies direct line-of-sight from requirement to proof.
- 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).
Submission-readiness brief
A short submission-readiness brief that checks structure and traceability and outlines next steps for your chosen conformity assessment route under MDR (Annex IX, X, or XI).
- 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: Consulting and documentation only. We do not perform laboratory testing, do not design label artwork, and do not act as a Notified Body. Annex III/PMS activities are not included in this package.
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.
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.
Collect
- 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.
Author & compile
- Map your UDI and product details into the GUDID data structure.
- Flag any missing essentials for you to confirm or correct.
Map & cross-reference
- 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.
Readiness & handover
- 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.
- Intended purpose, key claims, and classification rationale.
- Evidence list and file locations (test reports, CER/CEP, risk management file, usability, software, sterilization), including applied standards.
- Any existing Notified Body feedback you want reflected in the structure and mapping.
- An internal regulatory/quality contact who can clarify open points during TD assembly.
Consulting and documentation only. We do not perform laboratory testing, do not design label artwork, do not deliver Annex III/PMS activities in this package, and do not act as a Notified Body. Your organisation remains responsible for testing, labelling, PMS, and all formal submissions to Notified Bodies and authorities.
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. We assemble Technical Documentation according to Annex II and build an Annex I GSPR matrix. Together, these address the core content and traceability expectations for MDR conformity assessment.
No. We provide consulting and documentation only. You remain responsible for laboratory testing, label artwork, and all interactions with your Notified Body.
We structure the Technical Documentation and GSPR matrix so they fit your chosen route under MDR—typically Annex IX (QMS with assessment), Annex X (type examination), or Annex XI (production quality assurance).
Yes. We start from what you already have, identify gaps and inconsistencies, and then author and assemble a complete, traceable TD set with an aligned GSPR matrix.
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.
Build my Technical Documentation
We’ll reply with a proposed slot and a short intake checklist.
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