# API Traces Dashboard Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/features/apitraces Monitor your UDI API activity with real-time analytics, detailed feedback, and a complete request history.

The API Traces Dashboard, located as subpart of "Submissions" in the sidebar navigation, gives you a clear overview of your UDI API activity covering both **Validate** (data validation) and **Submit** (send to authority) operations. Instantly analyze trends, spot issues, and review every request in detail. * **Your UDI Markets:** Filter API requests by market to focus on specific regions. * **Status Summary:** See total requests, validation successes, failures, and errors at a glance. * **Interactive Analytics:** Visualize your API activity over time, identify spikes or issues, and drill down for details. * **Request History:** Review every API request including timestamp, market, operation type (Validate/Submit), status, and feedback. Use search and filters to find what you need fast. API Dashboard

> **Tip:** Use the dashboard to quickly identify validation or submission issues, improve your data quality, and keep your compliance workflows on track. The API Traces Dashboard brings all your API activity together so you stay in control and resolve issues faster. # Home Side Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/features/homeside Get instant insights into your UDI API activity—all in one place.

The starting page gives you a clear, real-time overview of your UDI API activity.\ Easily filter and monitor your API requests by market, track key metrics, and quickly spot issues—all from one dashboard. * **Quick Start Guide:** Get started with UDI Connect in just a few steps. * **UDI Markets:** Filter your API activity by region to focus on what matters most. * **API Traces:** Monitor all API requests, including both **Validate** (data validation) and **Submit** (sending data to the authority) operations. Track successes, errors, and trends with detailed feedback. * **Today's Highlights:** Instantly see today’s most important API stats. * **API Documentation:** Access everything you need for seamless integration. * **Compliance Map:** Visualize global activity and market status. > **Tip:** For detailed insights, start a [free trial](/versions/vers1_3/UDIConnect/getting-started/freetrial) and test it yourself. The starting page brings everything together so you can stay organized, compliant, and in control. # Environments Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/environments Overview of the dual-environment setup in UDI Connect (Preview and Production Environments). ## Understanding the Two-System Landscape UDI Connect now operates within a **dual-environment landscape**, consisting of the following two environments: * **Preview Environment** – Connected to the **authorities’ test systems**. This environment allows safe testing, validation, and preparation before live submissions. * **Production Environment** – Linked to the **official productive systems** of the authorities. This is the live environment used for regulatory submissions. This setup ensures that all onboarding, configuration, and submission activities can be validated in the Preview environment before going live in Production. *** ## Switching Between Environments In the **Settings** section, you can now choose the desired environment through the **“Go To App”** dropdown menu. * By default, clicking **Go To App** will redirect you to the **Production** environment. * To work in the Preview environment, simply select **Preview** from the dropdown menu before navigating. Preview and Production environment selection

Preview and Production environment selection

*** Use the Preview environment to safely test your setup and validate submissions before executing them in the Production environment. # Start Free Trial Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/freetrial Follow these steps to start your 14-day free trial for UDI Connect. * Go to the website [www.udihub.io](https://www.udihub.io). * On the homepage, there are several options to begin your free trial. Click on **Start Trial Now** or **Get Started** to begin. Get Started button on UDI Connect website

Get Started button on UDI Connect website

* You will be redirected to the UDI Solution sign-up page. * Enter the required details: * **First Name** * **Last Name** * **Email Address** * **Password** * Accept the **Terms of Service** and **Privacy Policy**, then click **Continue**. Sign-up screen for creating a new account

* You will receive a verification code via email. * Enter the code in the verification field and click **Continue** to proceed. * Provide the **Legal Company Name**. * Select your **Role** (e.g., Quality Manager, Regulatory Specialist, IT Admin ...). * Click **Continue** to move to the next setup step. Company name and role input screen

* Enter your **Organization Name** — this name will be used within the solution. * The **Product** is preselected based on where you started the trial (e.g., **UDI Connect**). * Optionally, you can switch to another product using the dropdown menu. * Click **Get started** to continue. Organization and product selection screen

Organization and product selection screen

* Wait for the initialization process to finish. * The system automatically provisions your **company**, **organization**, and **account** in the background. * After provisioning, you will be automatically redirected to your **UDI Connect dashboard** of the Production Environment. * You can start exploring the system, access the **Quick Start Guide**, or configure your settings.

You can use your free trial for 14 days. Start by exploring the Quick Start Guide and configuring your company and organization settings within UDI Connect. # Manage Team Members Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/manageteam How to invite and manage team members in your organization. * Navigate to the **Settings** section in the sidebar. * Click on **Team** to view and manage your organization's members. * In the **Team Members** section, enter the email address of the person you want to invite. * Select the appropriate role (**org:member** or **org:admin**) from the dropdown. * Once both fields are filled, the **Invite Member** button becomes active. Invite new member

* Click **Invite Member** to send the invitation. * The invited user will receive an email with a link to join your organization. * Pending invitations appear under the **Pending Invitations** tab. * You can resend the invitation by clicking **Resend** or cancel it by clicking **Cancel** if needed. Resend or cancel invitation

* The invited user needs to click on the link in the email invitation. * Please check your **SPAM** folder if you don't see it in your usual inbox. * The link will open a screen to set up a password. * After setting up an account, they are redirected to the application. * Once the invited user accepts the invitation, they will appear under **Members**. * The new member now has access to the system according to their assigned role. Members list

# Manage Organization Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/organizationonboarding Organization Settings – Manage Legal Manufacturers and Market Assignments Keep your organization’s legal manufacturer information up to date and assign responsibilities for different markets and authorities. Centralized management helps you stay compliant and organized, especially when expanding into new markets. * In the sidebar, go to **Settings** and select **Organization**. * Here you can view and manage all legal manufacturers and their market assignments. Application

* Click the **Add Manufacturer** button. * A popup will appear where you can enter the details of the legal manufacturer. * After entering all required details, click **Add Manufacturer** to save. Add Manufacturer Light

> **Explanation:**\ > In the "Assigned Markets" section, specify which manufacturer is responsible for which authority.\ > Currently, this is only relevant for EUDAMED. As additional markets are added in the future, this overview will help you easily see which manufacturer is assigned to each market.\ > This feature is especially useful if you centrally manage registrations through this solution. * The table now lists the created manufacturer. * Add further, if you manage more manufacturers centrally. * On the right side, you can edit the details or delete an entry as needed. Manufacturer Maintained Light

# Quick Start Guide Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/quickstartguide Learn how to set up your system to be submission ready. Follow the steps below to get started quickly. Each step includes a direct link to the relevant section for more details. How you get access to a free trial for 14 days. Set up and manage all your key information for your organization and manage members. Invite and manage your team members who should have access to the application. Learn how the API expects your requests to be structured and what the response format looks like. Learn more about API request/response structure. The API key is required for authentication and authorization of all requests. Find out how to securely generate and use your API key. How to generate and use your API key for secure access. Authority onboarding is mandatory to unlock m2m submission capabilities for regulatory agencies. Follow the step-by-step guide to complete this process. Step-by-step guide to unlock m2m submission functionality. # Docu Changelog Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/changelog Keep track of changes and updates. * Screenshot adjustments due to new layout in some areas. * New section for environments. Initial documentation created for UDI Connect. # Info Section & Support Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/infosection Access key resources, stay updated on new features, and connect with support all from the Info Section in the sidebar. ## Getting Started Quickly learn the basics of UDI Connect: API documentation, API key management, authority onboarding, and the validate/submit workflow. [**Getting Started**](/versions/vers1_3/UDIConnect/getting-started/quickstartguide) – General onboarding and API requirements. ## User Guide Find detailed documentation and feature explanations within this user guide to help you get the most out of UDI Connect. ## What’s New? Check the latest features, improvements, and release notes. [**Release Notes**](https://projektraum36.releasedhub.com/udi-connect/changelog) – Stay informed about current and upcoming updates. ## Need Help? Visit our support board to ask questions, report issues or request features. [**Support Desk**](https://projektraum36.atlassian.net/servicedesk/customer/portal/42) – Contact us directly for assistance. # Overview Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/introduction # Welcome to the Documentation of UDI Connect Discover UDI Connect, a fully API-driven solution designed to streamline and automate your global UDI compliance processes. Gain a quick overview of UDI Connect. ## Quick Start Guide Learn how to set up your system to be submission ready. Follow the Quick Start Guide to manage all necessary steps to enable machine-2-machine submissions. How you get access to a free trial for 14 days. Set up and manage all your key information for your organization and members. Invite and manage your team members who should have access to the application. Learn how the API expects your requests to be structured and what the response format looks like. The API key is required for authentication and authorization of all requests. Find out how to securely generate and use your API key. Step-by-step guide to unlock m2m submission functionality. ## Get to know more about the User Interface Dive deeper into UDI Connect to explore the UI features, reporting views and unlock its full potential for managing your compliance needs. Quickly navigate through key areas and stay updated with the latest highlights. Track your API requests and review their status in one centralized view. ## Have Questions or need Support? We're here to help! Discover useful resources and get the support you need. Find helpful resources like user guides, release notes, roadmap and support board. # What is UDI Connect? Source: https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/introduction_udiconnect Connect

UDI Connect is a cloud-based, API-driven solution designed to simplify global Unique Device Identification (UDI) compliance for medical device manufacturers, importers, and distributors.\ The solution enables validation and submission of UDI data to international regulatory databases, supporting machine-to-machine integration and real-time monitoring. UDI Connect automates compliance workflows, reduces manual effort, and increases transparency across all UDI activities.\ Compatible with leading ERP systems such as SAP, Oracle, Infor, and Microsoft Dynamics, UDI Connect centralizes compliance tasks to help organizations keep pace with evolving regulatory requirements. # Change Log (Audit Trail) Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/changeLog See who changed what and when in UDI Hub, including Upload, Import, and Submit actions, system-driven status changes, validation outcomes, and PDF audit trail export. ## Overview The **Change Log** provides a complete audit-friendly history of actions and status changes for a **Basic UDI-DI** or **Device** in UDI Hub. It helps you answer: * **Who** performed an action (user or system) * **What** happened (Upload / Import / Submit, approvals, validations, status changes) * **When** it happened (timestamp) * Whether validation was **successful** or **not successful** * How the history differs between **versions** (e.g., initial registration vs. updates) Change Log in the Details modal

*** ## Where to find it 1. Open **UDI Management** 2. Open the **Details** modal of a **Basic UDI-DI** or **Device** 3. Go to the **Change Log** tab *** ## Version-specific view vs. complete history In the Change Log you can switch between: * **Current Version (vX)** — shows changes related to the currently selected **version** * **Complete History** — shows the full history across all versions This is useful to distinguish what happened during: * **Version 1** (initial registration), versus * **later versions** (updates / follow-ups) *** ## What you will see in the log Each log entry typically includes: * an **event title** (e.g., *New Import for Device*, *Submission triggered*, *Approval for Device*) * the **actor** * a **user** (when triggered manually, e.g., import or submission) * **System** (when statuses are set automatically in the background) * a **timestamp** * optional **details** you can expand via **Show details** The Change Log includes, among others, these types of events: * **Upload**: file upload activity that leads into validation * **Import**: import actions * **Submit**: a submission being triggered for a Basic UDI-DI or Device * **Validation**: e.g., *Validation Successful* or validation failures * **System status updates**: e.g., approvals set after successful import Change Log entries showing import and validation results

Change Log entries showing import and validation results

*** ## Export an Audit Trail (PDF) For audits and internal documentation, you can export the audit trail as a PDF: 1. Open the **Change Log** tab 2. Click **Download Audit Trail** 3. Choose the required export option (e.g., for the current version or complete history, depending on your configuration) This export provides a shareable audit document containing the recorded history. *** Use Current Version when you want to explain or troubleshoot a single submission/update cycle.\ Use Complete History to provide a full audit trail across initial registration and all updates. # Download Templates Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/downloadTemplates Learn how to download and understand the official Excel templates in UDI Hub for preparing and importing UDI data. ## Overview The **Download Templates** feature in **UDI Hub** provides ready‑to‑use Excel workbooks that follow the required data model for each regulatory market.\ These templates define the exact structure and field naming needed for successful imports and validations — ensuring your data aligns with each authority’s submission format. Currently, **EUDAMED** is available as the first supported market within UDI Hub.\ More markets and legislation types will be added as the global UDI coverage expands. Within EUDAMED, you can choose between the following legislation types: * **MDR** – Medical Device Regulation * **IVDR** – In Vitro Diagnostic Regulation * **SPP** – Systems and Procedure Packs Each legislation type provides templates for both **Basic UDI‑DI** and **Device** records. *** ## How to Download Templates 1. Navigate to **Import Data → Excel Import** in the sidebar. 2. Under **Market**, select the target market (currently EUDAMED). 3. If available, choose the **Legislation Type** (MDR, IVDR, or SPP). 4. Select the **Template Type** you need — either **Basic UDI‑DI** or **Device**. 5. Click **Download Template** to generate and save the Excel file.

You can now use this Excel workbook to prepare new data or update existing records before uploading them back into UDI Hub. *** ## Understanding the Excel Template Structure Each Excel template in UDI Hub is structured into multiple worksheets to reflect how data is modeled in the authority database.\ This design allows clear separation between one‑to‑one fields, multi‑select values, and complex repeatable elements. excelmain

### 1. Main Sheet – Primary Device Data The first working tab contains all information in a **1:1 relationship** with the device identifier (UDI‑DI). Typical data points include: * Device# (Article Number) * Device Description * Reference Number * Manufacturer SRN * Single Use * Sterilization * ... Each row in this sheet represents **one unique device record**. excelfirstsheet

*** ### 2. Multiselect Sheets – Values with Multiple Options Some data points allow multiple values for one device.\ For these, additional sheets are provided to capture all possible entries. A key example is **Production Identifier**, where you can define multiple identifiers for a single device: * Manufacturing Date * Expiration Date * Serial Number * Batch Number Each entry in these sheets links back to the device in the main sheet using a reference field. multiselekt

*** ### 3. Complex Elements – Repeated Attribute Groups Certain data sets require multiple detailed values per device. These are represented as **complex elements**, stored on separate sheets. A common example is **Clinical Sizes**.\ This sheet allows you to specify multiple dimension attributes for one product.\ For instance, a device can have several size indicators, each with its own value and unit: * Length – 15 mm * Width – 5 mm * Height – 3 mm Each combination is associated with the corresponding device record, ensuring proper linkage during validation. clinicalsizes

*** ## Summary of Sheet Types **Main Sheet**\ Contains general product details (1:1 relationship per UDI‑DI).\ Example: Device sheet for identifiers, references, and general product data. **Multiselect Sheet**\ Used for lists of values linked to a single device.\ Example: Production Identifier sheet for manufacturing and batch data. **Complex Element Sheet**\ Used for structured data with multiple attributes per device.\ Example: Clinical Sizes sheet for physical measurements. *** ## Best Practices * Always download the **latest template version** for the selected market and legislation. * Do not edit sheet names or column headers — these must remain unchanged for validation. * Fill out all **mandatory fields** before import. Otherwise they will run into a validation error as not comply to regulatory requirements. * You can test in Preview (Test Environment) before uploading to Production. * The filled templates can be downloaded again after upload. ## Troubleshooting * **Use Copy & Paste carefully:**\ Hidden columns at the end of the template contain technical keys required for upload. Copying entire rows or including hidden columns can overwrite or delete these keys. ⚠️ **If keys are changed or lost, uploads may fail even if data looks correct.** **Recommendations:** * Copy only visible cells — never full rows. * Avoid editing or un-hiding system columns. * Use the latest template if errors persist. * Test uploads in the Preview environment before Production. *** Work **per product group** when filling your templates.\ This helps you reuse shared values across products by copying them down consistently, which improves data integrity, reduces manual effort, and makes potential errors easier to identify. # Home Side Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/homeside Get an overview of your UDI Hub workspace – from key tasks and submission status to global compliance insights.

The **Home Side** in **UDI Hub** provides a central entry point into your compliance workspace.\ It gives you instant access to your most important actions, system KPIs, and regulatory insights — all from one dashboard. *** ## Quick Start Guide Get started quickly by following the embedded **Quick Start Guide** section.\ Here you can easily revisit onboarding steps, manage your organization, and set up your environment for submissions.

Access a guided overview of all essential setup steps in UDI Hub. *** ## KPI Overview & To‑Do Cards Stay on top of your operational priorities with intuitive KPI‑Cards displayed directly on the Home Side. * **Ready for Submission** — See how many validated data records are prepared and ready to be submitted to the authority. * **Submission Errors** — Instantly identify submissions that require attention. These KPIs help you prioritize tasks and maintain a clear overview of your organization’s UDI status. *** ## Compliance Map Visualize the current global state of UDI implementation with the interactive **Compliance Map**.\ It highlights countries where UDI regulations are already **mandatory**, **active**, or **under discussion** – giving you an instant picture of market coverage and upcoming regulatory changes.

> **Tip:** Use the Compliance Map to strategically plan ahead for new authority integrations and market expansions. *** The Home Side brings your most essential information together – guiding your daily actions and helping you stay organized, efficient, and compliant within UDI Hub. # Details Modal Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/modal Open the Details modal from UDI Management to review version-specific data stored in UDI Hub and key statuses at a glance. ## Overview The **Details modal** shows a consolidated, read-only view of a **Basic UDI-DI** or **Device** record in UDI Hub.\ It is mainly used to review the **data snapshot per registration version** and the current status indicators. *** ## Open the modal ### Devices In **UDI Management → Devices**: 1. Open the row actions menu (**⋯**) 2. Click **View Details** View Details from the actions menu (⋯) in Devices

View Details from the actions menu (⋯) in Devices

### Basic UDI-DIs In **UDI Management → Basic UDIs**, open details via the **eye icon** on the Basic UDI-DI card. Open Basic UDI-DI details via the eye icon

*** ## What you can do * See key indicators: **Maintenance Status**, **Submission Status**, **Registration Status**, **Registration Version** * Use the **Version** dropdown (top right) to switch versions * On **Device Data**, review the version-specific values stored in UDI Hub (snapshot for that version) The Submission Status and Change Log tabs are explained in separate handbook entries. # Submission History Timeline Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/submissionHistory Track the submission progress per registration version, from UDI Hub processing to authority handover, authority response, and publication. ## Overview The **Submission History** (Status Timeline) helps you understand what happened to a **specific registration version** of a **Basic UDI-DI** or **Device**. It is available inside the **Details modal** and provides a clear timeline of the submission lifecycle — including technical handover to the authority, the authority’s response, and the final publication status. *** ## Where to find it 1. Open **UDI Management**. 2. Open the **Details** modal of a **Basic UDI-DI** or a **Device**. 3. Select the tab **Submission Status**. 4. Use the **Version** dropdown (top right) to switch between **registration versions** and see the corresponding submission history for each version. Submission Status Timeline - successful example

Submission Status Timeline - successful example

*** ## How to read the timeline The timeline is divided into four stages: | Stage | Meaning | | ------------------------ | ------------------------------------------------------------------------------------------------------------------ | | **Submission Interface** | The submission is being processed inside **UDI Hub** (payload generation, orchestration, submission to authority). | | **Authority** | The submission was technically handed over to the authority system (e.g., EUDAMED). | | **Authority Response** | The authority returned a response indicating **success** or **error** (including details). | | **Published** | The item was successfully **published** by the authority and is considered finalized for that version. | ### Successful flow example In a successful case, all stages are completed and **Published** is reached. Successful submission timeline reaching Published

Successful submission timeline reaching Published

### Error / rejection example If the authority rejects the submission, the timeline stops at **Authority Response** and shows the error details provided by the authority. Rejected submission timeline with authority error details

Rejected submission timeline with authority error details

*** Use the Version selector to compare what changed between submissions (e.g., Version 1 initial registration vs. Version 2 update) and to identify exactly where a submission failed (UDI Hub processing vs. authority response). # Manage Basic UDIs Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/udiManagementBUDIs View, manage, and monitor all Basic UDI-DIs and their assigned devices within UDI Hub. ## Overview The **Manage Basic UDIs** section in **UDI Hub** displays all imported and validated Basic UDI‑DIs and provides a central overview of their current lifecycle, submission, and registration states.\ It serves as the main entry point to monitor the regulatory progress of each product group and its assigned devices. Each Basic UDI‑DI is represented as a **card**, showing key identifiers and status information at a glance.\ Users can easily review the complete group status, navigate to assigned devices, and open detailed views when needed. budis

*** ## Basic UDI-DI View After successful import, each Basic UDI‑DI is listed on the page with the following key attributes: * **Basic UDI‑DI code** * **Regulatory Actor** (e.g., Legal Manufacturer SRN) * **Legislation** (MDR, IVDR, or SPP) * **Risk Class** * **Maintenance Status** * **Submission Status** * **Registration Status** * **Registration Version** When selecting a Basic UDI‑DI card, a detail panel opens on the left side where you can view all related devices that are **assigned** to this Basic UDI‑DI.\ This provides a clear and centralized overview per **product group**, supporting traceability and monitoring across the entire portfolio. *** ## Status Information Each Basic UDI‑DI and its assigned devices include several key status indicators that describe their current state in the UDI process. ### Maintenance Status The **Maintenance Status** reflects the data lifecycle state within UDI Hub. * **Draft** – Will be implemented later for in app edit functionalities. * **Approved** – The data is validated and ready for submission.\ *(Set automatically by the system after successful import.)* ### Submission Status The **Submission Status** indicates the current submission stage: * **Ready for Submission** – The Basic UDI‑DI can be submitted to the authority. * **In Progress** – Submission has been triggered. * **Error** – A submission error occurred; details are available in the submission tab. * **Published** – Submission has been successfully processed and is accepted by authority. This status helps identify records that might require user actions. ### Registration Status The **Registration Status** shows the outcome of submissions with the authority: * **Not Available** – No registration yet. * **Published** – Successfully registered and published in the authority database the first time. * **Updated** – An existing registration was successfully updated. ### Registration Version Indicates how many times the Basic UDI‑DI has been successfully registered or updated with the authority.\ It serves as an audit reference for tracking revisions and resubmissions over time. *** ## Detailed View To review details for a specific Basic UDI‑DI, click the **eye icon** on its card. This opens the **Basic UDI‑DI Details** window, which contains three tabs: 1. **Basic UDI‑DI Data**\ Displays all attributes that were imported into the system. 2. **Submission Status**\ Shows submission details, including trigger date, current status, and — if applicable — error messages returned by the authority or success message. 3. **Change Log**\ Lists all tracked changes and versioned updates for this Basic UDI‑DI, including timestamps, responsible users, and previous values. The details panel always shows the active version by default, but older versions can be viewed when needed. *** ## Delete Entries You can **delete** a Basic UDI‑DI only if: * It has **not been successfully submitted** to an authority, and * **No devices** are currently assigned to it. This restriction ensures data traceability and regulatory compliance.\ Deleting allowed records helps maintain data accuracy and removes entries that were created in error, without compromising audit integrity. *** Use the **Basic UDI-DI overview** to review the status of an entire product group.\ This structure gives you clear visibility of the overall maintenance and registration statuses, allowing quicker identification of inconsistencies and better control over your submission readiness. # Manage Devices Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/udiManagementDevices Track, manage, and review all imported device records, their validation statuses, and registration progress within UDI Hub. ## Overview The **Manage Devices** section in **UDI Hub** provides a comprehensive overview of all imported and validated device records.\ It allows users to track maintenance, submission, and registration statuses for each individual UDI‑DI and manage lifecycle actions such as corrections, reviews, and deletions. While devices are automatically linked to their corresponding **Basic UDI‑DI**, this area focuses on **individual device entries** and their regulatory progress within the system.\ This view helps users ensure data integrity, identify failed submissions, and monitor compliance readiness for each item. devices

*** ## Device Overview Table All device entries are displayed in a tabular layout, providing a quick and detailed insight into all available records. Each row represents one **device** and contains the following main columns: * **UDI Market** – Market or authority to which the device applies (currently EUDAMED). * **UDI‑DI** – Device identifier as listed in the imported Excel file. * **Legislation** – Shows the regulation type such as MDR or IVDR. * **Basic UDI‑DI** – The parent Basic UDI‑DI the device belongs to. * **Device / Device Name** – Internal identifier and descriptive name of the device. * **Maintenance Status** – Displays the current system state of the dataset. * **Submission Status** – Indicates the current submission stage. * **Registration Status** – Displays whether the device has been successfully registered. * **Reg. Version** – Shows how many times the device registration has been updated. You can use the **filter bar** at the top to narrow the list shown. It is also possible to filter devices by **Basic UDI‑DI**, allowing a clear product‑group view when required. *** ## Status Indicators Devices share the same core status concepts as Basic UDI‑DIs, providing consistent tracking across both levels. ### Maintenance Status Defines the current data lifecycle of the device record within the system. * **Draft** - Will be implemented later for in app edit functionalities. * **Approved** – The device has passed validation and is ready for submission (set automatically after import). ### Submission Status Shows progress in the submission workflow: * **Ready for Submission** – The Basic UDI‑DI can be submitted to the authority. * **In Progress** – Submission has been triggered. * **Error** – A submission error occurred; details are available in the submission tab. * **Published** – Submission has been successfully processed and is accepted by authority. ### Registration Status Indicates the registration result within the authority database: * **Not Available** – Not yet submitted or registered. * **Published** – Successfully registered and published. * **Updated** – A previously registered device has been updated successfully. ### Registration Version Displays how many successful registrations or updates exist for the device.\ This number helps users identify revised data versions and ensures traceability over time. *** ## Detail View and Data Tabs To review and manage the details of a device entry, click the **eye icon** at the end of a row.\ This opens the **Device Details** modal that contains all device‑specific information divided into three tabs. ### 1. Device Data Displays the complete dataset as imported from the Excel template, including all validated attributes such as identifiers, manufacturer SRN, reference numbers, classification, and physical properties.\ This view represents the active version of the data currently stored in UDI Hub. ### 2. Submission Status Shows the current submission process and any associated feedback from the authority.\ Users can check when a submission was triggered, monitor its progress, and review authority response messages or error details when applicable. ### 3. Change Log Provides a complete audit trail of changes for this device, including timestamps, responsible users, and prior version information.\ Older data versions remain available for traceability and audit purposes. *** ## Delete Function A device entry can be deleted only under specific compliance conditions: * The device **has not yet been successfully submitted or registered** with an authority. * It **is not linked** to any higher dependencies that would cause traceability conflicts. Deleting devices that meet these criteria helps maintain a clean dataset and eliminates test or incorrect entries while ensuring compliance and audit integrity are preserved. *** ## Working With Product Groups Although the **Manage Devices** table focuses on individual device entries, the system maintains a clear link between **Basic UDI‑DIs** and their corresponding **devices**.\ This connection allows users to: * Filter and review devices **per Basic UDI‑DI**. * Identify product‑group‑level issues quickly (e.g., if several related devices show the same error status). * Maintain group consistency by aligning maintenance and submission activities across all connected devices. This approach simplifies lifecycle coordination between Basic UDI‑DI and Device levels and provides full visibility for compliance tracking. *** Use the **Manage Devices** view to monitor the health of your device data portfolio.\ By regularly reviewing validation and registration statuses, you can identify issues early, ensure group consistency with linked Basic UDIs, and keep your product data always submission‑ready or closed. # Submission Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/udiManagementSubmission Learn how to submit data to EUDAMED. ## Overview The **Submission** flow in **UDI Hub** is started from **UDI Management**, typically from the **Basic UDI-DI Status Overview** page. From there, you can: * submit a **Basic UDI-DI** (BUDI) and one device for an **Initial Registration** * automatically **queue (waitlist)** additional devices for submission once the initial registration is accepted * submit additional devices later as **Follow Up / New Device** * submit **updates** for either the Basic UDI-DI or for individual devices (after initial registration) Basic UDI-DI Status Overview (Dashboard)

Basic UDI-DI Status Overview (Dashboard)

*** ## Step-by-step: Start a Submission from UDI Management ### 1. Open the Basic UDI-DI and view assigned devices In **Basic UDI-DI Status Overview**, select a **Basic UDI-DI card**.\ The assigned devices for this Basic UDI-DI are shown on the right side. Click Basic UDI-DI card to display assigned devices

Click Basic UDI-DI card to display assigned devices

### 2. Select what you want to submit (BUDI and/or devices) Use the checkboxes to select: * the **Basic UDI-DI** (left) * one or more **devices** (right) At the bottom you’ll see a running selection counter (e.g., `4 items selected`). Selected Basic UDI-DI and devices

### 3. Start the guided flow with **Review & Submit** Click **Review & Submit** to open a guided modal.\ This modal validates your selection, explains what will happen, and lets you submit. *** ## Guided Modal: Market → BUDIs → Devices → Submit ### Step A — Select target market (currently EUDAMED) First, confirm the **target authority/market**.\ Today the flow shows **EUDAMED**, but the UI is designed to support multiple authorities later. Review & Submit - Select target market (EUDAMED)

Review & Submit - Select target market (EUDAMED)

Click **Continue**. *** ## Initial Registration: Basic UDI-DI + paired Device (EUDAMED rule) If your selection includes a Basic UDI-DI that has **never been successfully submitted to EUDAMED**, the modal runs the **Initial Registration** path. ### Step B — BUDI validation & submission type (INITIAL) UDI Hub validates that the Basic UDI-DI is: * in a **Ready for Submission** state, and * eligible for the required **submission type** For an **INITIAL** registration, EUDAMED allows submission of: * **1 Basic UDI-DI + exactly 1 device** (paired device) Therefore, UDI Hub asks you to select the **paired device** for the initial registration: * the system automatically preselects the **first valid device** * you can change the paired device here if needed BUDI validation (INITIAL) and device pairing

BUDI validation (INITIAL) and device pairing

Click **Continue**. ### Step C — Device validation, grouping, and waitlisting Next, UDI Hub validates the selected devices and groups them by their parent Basic UDI-DI. In an **Initial Registration** scenario: * the **paired** device will be **submitted now** * any additional selected devices are placed in a **QUEUE / Waitlist** **Waitlisted (Queued)** devices will be submitted automatically as **follow-up registrations** after the initial paired BUDI/device submission has been accepted by EUDAMED. Device validation with paired device and waitlisted devices

Device validation with paired device and waitlisted devices

Click **Continue** to reach the summary and then submit. ### Step D — Submit to EUDAMED In the final step, review the summary and click **Submit to EUDAMED** to initialize the submission. Summary and submit to EUDAMED

After submission, a success card confirms which submission types were started. Submission success confirmation

### Observe the process (Refresh) Back on the overview page, you can use **Refresh** to observe status changes: * the paired Basic UDI-DI + device go **In Submission** * once successful, they switch to **Published** * **waitlisted** devices are then automatically triggered and submitted Waitlisted devices while initial submission is in progress

Waitlisted devices while initial submission is in progress

When waitlisted devices are triggered, you will see the follow-up submission start automatically: Automatic submission of waitlisted devices

Finally, devices also switch to **Published** after successful processing. Published state after successful submissions

*** ## Follow Up: Submit additional devices as **NEW DEVICE** After a Basic UDI-DI is successfully **Published**, you can submit additional devices later as a **Follow Up**. ### What changes compared to INITIAL? * you select **devices only** (no Basic UDI-DI selection required) * the **BUDI step is skipped** in the modal * devices are labeled as **NEW DEVICE** * devices are submitted directly (no waitlist needed if BUDI is already published) In the **Devices** step, UDI Hub lists the devices under the parent Basic UDI-DI and marks them as: * **SUBMIT NOW** * **NEW DEVICE** Follow-up device validation: NEW DEVICE

Proceed through the summary: Follow-up summary

And submit: Follow-up submission success

You can either submit **all devices at once** (managed via **Waitlisted** during INITIAL) or submit devices in **portions** via follow-ups.\ For reliability, currently keep each batch **≤ 500 devices** while performance optimizations are ongoing. *** ## Updates after initial registration (BUDI and devices become independent) After the initial registration is successful (BUDI and at least one device are **Published**): * **Basic UDI-DI** and **Devices** are considered *decoupled* for updates * you can submit **BUDI updates** and **device updates** independently * each update creates a new **Registration Version** for the updated entity ### How updates are triggered Typically, an update starts when you change data via **Excel upload/import**: * **Maintenance Status** changes (e.g., to **Approved**) * **Submission Status** becomes **Ready for Submission** ### Example: Basic UDI-DI update If the Basic UDI-DI is **Ready for Submission**, select the **Basic UDI-DI** and click **Review & Submit**. Basic UDI-DI moved back to Ready for Submission after data changes

Basic UDI-DI moved back to Ready for Submission after data changes

In the modal, only the **BUDIs** step is relevant and the item is labeled as **BUDI UPDATE**. BUDI validation shows BUDI UPDATE

After successful submission, the Basic UDI-DI switches to: * **Registration Status: Updated** * **Registration Version: 2** (or higher for subsequent updates) BUDI update successful: Updated, version 2

BUDI update successful: Updated, version 2

*** ## Blocked / excluded items and filtering UDI Hub can validate mixed selections (BUDIs and/or devices).\ If some items cannot be submitted (e.g., invalid status or rule violations), the modal highlights them as **excluded**. ### Blocked BUDI example Blocked BUDI example: will be excluded

### Blocked device example Blocked device example: excluded from submission

If your selection contains both **submittable** and **non-submittable** items, UDI Hub offers to: * **Review Excluded Items** (inspect the issues), or * **Filter and Continue** (proceed only with valid items) Filter excluded items and continue

*** ## Important note: High Risk devices with certificates (feature gap) For **Basic UDI-DIs / devices** where **certificates** are provided and a **Notified Body** approval is required, the end-to-end status synchronization is **not fully implemented yet**. Current behavior: * the item may remain in **Submitted** * follow-up **updates** may be blocked until the authoritative status is retrieved Planned improvement: * a **GET Device Status** feature to pull the final status back into UDI Hub automatically High risk / certificate case (known limitation)

High risk / certificate case (known limitation)

If certificates / Notified Body approval are involved, UDI Hub may currently not transition items from Submitted to Published automatically.\ This can prevent subsequent updates until status retrieval is available. *** ## Submission types & concepts (cheat sheet) | Concept / Label | When it happens | What it means | Typical system behavior | | -------------------------- | ------------------------------------------------------------- | --------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- | | **INITIAL** | First ever successful EUDAMED registration for a Basic UDI-DI | EUDAMED requires **1 BUDI + 1 paired device** | You must pick a **paired device**; only that pair is submitted immediately | | **QUEUED / Waitlisted** | During INITIAL, when you selected **additional devices** | Devices are queued for later follow-up once INITIAL is accepted | Devices stay **Waitlisted** and are triggered automatically after BUDI + paired device become **Published** | | **Follow Up / NEW DEVICE** | Adding devices to an **already published** Basic UDI-DI | New device registration under an existing BUDI | Devices are labeled **NEW DEVICE** and can be submitted directly | | **BUDI UPDATE** | After data changes to a published Basic UDI-DI | Update of the Basic UDI-DI registration | Registration version increases (e.g., **2**) and status becomes **Updated** | | **Device Update** | After data changes to a published device | Update of an individual device registration | Device can be updated independently from the BUDI (after initial registration) | *** For an INITIAL registration, decide early whether you want to submit **all devices at once** (managed via waitlisting) or in **smaller follow-up batches**.\ Until performance improvements are complete, stay below **500 devices per submission** for best reliability. # Import Data (Upload and Import Data) Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/uploadTemplates Learn how to upload, validate, and import Excel data files in UDI Hub, including version handling, error management, and import logic. ## Overview The **Import Data (Upload and Import Data)** section in **UDI Hub** allows you to upload, pre‑validate, and import Excel templates into the system.\ This is the central point for managing your UDI data entry process — from initial validation to the final import into the productive database. The purpose of this area are two‑steps: 1. **Upload** – Validate and review data before committing it to the system. 2. **Import** – Transfer validated and compliant data into the UDI Hub database. Validations are performed to ensure that all mandatory information is provided, data follows business rules defined by the authorities, and that relationships between Basic UDI‑DIs and Devices remain consistent. uploadhistory

*** ## Upload Area At the top of the page, you will find the **upload zone**.\ Here you can drag and drop your prepared Excel file (e.g., Device or Basic UDI‑DI template). After a file has been dropped: 1. You can add a **Change Name** — a custom label that helps track modifications and provides clear traceability in the history log. 2. Click **Generate Instance** to create a new upload instance.\ This step triggers an entry in the **Upload History** table below. dropfile

Once the instance is generated, the system automatically starts the **validation process**. In the **Validate** column, you will see the current validation status: * **Processing...** – The uploaded data is being checked. * **Validated** – All business rules and mandatory fields are fulfilled. * **Validated with Errors** – The file contains errors or missing data that must be corrected. The validation time depends on the file size and the amount of data being processed. processing

*** ## Validation Results and Error Review When validation is completed, you can click on the **status** (e.g., Validated with Errors) to open detailed feedback. You will see a list of all **identifiers** included in the uploaded file, categorized into: * **Valid** – entries that passed validation and are ready for import. * **Invalid** – entries that failed mandatory or business‑rule validations. Selecting a specific identifier opens a detailed error report on the right‑hand side.\ Below that, the **Details** section lets you review all data values that will be written into the system. valid

If corrections are required, you can **drop a new Excel file** directly into the header area to replace or update the current instance.\ This enables quick iteration and revalidation without losing historical traceability. In the header, the uploaded file name (e.g., `Name.xlsx`) appears as a blue, clickable link — allowing you to download exactly the file that was uploaded.\ You can also adjust the **Change Name** later if needed for better documentation. invalid

*** ## Import Process Once a dataset is fully validated and has no remaining errors, the **Import Process button** becomes active in the Upload History list. Clicking **Import** transfers the validated data into the UDI Hub system.\ At this stage, the data becomes **visible and usable** under **UDI Management**.\ Until the import is completed successfully, uploads don't create or change data within the system. *** ## Upload vs. Import — What Happens in Each Step Before data becomes part of the UDI Hub database, it goes through two separate stages: **Upload** and **Import**. ### Upload During **Upload**, the system extracts and validates data from the Excel file and stores it as an **upload instance** in the database.\ However, this step does **not yet generate a data record or version** in the productive **Data Management** area. To support data entry, each Excel template provides three built‑in user aids: 1. Each **column header** includes a short description that explains the purpose of the field. 2. A **red asterisk (\*)** marks **mandatory fields** that must always be filled in for successful validation. 3. **Bold column headers** indicate **DI Triggers** — fields that, when changed, can trigger a new version after publication. These visual indicators help users understand which fields are required and which may have regulatory impact. * During upload, validation runs against the UDI Hub **data model**, ensuring correct structure, field formats, and mandatory or dependent mandatory fields. * **DI Trigger rules** are checked to ensure no restricted updates after publication. * It also applies business rules defined in the internal **validation rule catalog** aligned with authority requirements. * Since no active record or version is created yet, users can safely delete or replace an upload instance if data needs to be corrected. This design gives flexibility to correct and re‑validate before committing data to production. ### Import Once a file has been successfully validated, the **Import** step transfers its content into the **productive data layer**, creating a **new version** of the data.\ At this point, the data becomes active and visible within **UDI Management**. * Before import, a brief **re‑validation** ensures the file still aligns with the current data model (important if changes occurred since the initial upload). * The import focuses on **system integrity and process control**, including: * Ensuring that referenced **Basic UDI‑DIs** already exist before device data is imported. * Blocking imports if an existing record (e.g., a device) is **still in process or submission**, to prevent inconsistencies between UDI Hub and external authority systems. * Only after all checks pass is the data written as a new version to the system. This multi‑step approach ensures data quality, compliance, and consistent synchronization with external systems. *** ## Upload History Table history

The **Upload History** table lists all upload instances and tracks their complete lifecycle: | Column | Description | | ------------------ | ------------------------------------------------------------------------------------------------- | | **Timestamp** | Date of latest change of upload instance. | | **UDI Market** | Market for which the identifiers are created or updated. | | **Type** | Shows if it relates to a Device or Basic UDI-DI. | | **Legislation** | Shows to which legislation the upload applies (only applicable for EUDAMED until now). | | **Change Name** | Custom label for version tracking. | | **Validate** | Displays the current validation state (Processing / Validated / Validated with Errors). | | **File Name** | Name of the file that was uploaded. | | **Import Process** | Button to trigger the import for validated instances. | | **Actions (⋯)** | Options to **Download** the Excel again or **Delete** an instance that has not yet been imported. | Deleting an unimported instance ensures that no outdated files remain in the system and that change logs stay consistent. *** ## Change Tracking and Re‑Uploads Every upload generated in UDI Hub is stored with its **timestamp** and **change name** for complete traceability.\ When multiple uploads for the same dataset occur, the latest instance replaces earlier versions but keeps the historical log for auditing. If a correction file is uploaded, the system automatically re‑validates it and updates the status accordingly.\ This ensures that validation feedback is always based on the current version of your Excel file. *** Use the **Upload** step to validate your data early in the process.\ By detecting and correcting issues ahead of time, you can avoid last‑minute delays, ensure smoother imports, and maintain reliable data quality across long‑term cycles. # Environments Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/environments Overview of the dual-environment setup in UDI Hub (Preview and Production Environments). ## Understanding the Dual-Environment Landscape **UDI Hub** operates within a dual-environment setup that separates testing from productive submissions.\ This structure ensures that data imports, validations, and submissions can be thoroughly tested before being executed in the live environment. The two environments are: * **Preview environment** – Connected to the **authorities’ test systems**.\ Use this environment to safely import, validate, and verify UDI data, as well as to perform test submissions following real authority logic. * **Production Environment** – Connected to the **official live systems** of the authorities.\ This environment is used for approved submissions of validated and compliant UDI records. This setup guarantees that all data preparation, validation, and submission workflows can be verified in Validation before going live in Production. You can use dummy data or real data in your test system. Just keep in mind that some authorities require different credentials (consult authority onboarding for more details). *** ## Switching Between Environments Within the **Settings** section of UDI Hub, you can easily choose the active environment from the **“Go To App”** dropdown menu. * By default, clicking **Go To App** redirects you to the **Production** environment. * To work in the Preview environment, simply select **Preview** from the dropdown list before navigating. Validation and Production environment selection

Validation and Production environment selection

*** Use the Preview environment to safely test data imports, authority logic, and submission workflows before executing them in the Production environment. # Start Free Trial Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/freetrial Follow these steps to start your 14-day free trial for UDI Hub. * Go to the website [www.udihub.io](https://www.udihub.io). * On the homepage, there are several options to begin your free trial. Click on **Start Trial Now** or **Get Started** to begin. Get Started button on UDI Hub website

* Enter your **Organization Name** — this name will be used within the solution. * The **Product** is preselected based on where you started the trial (e.g., **UDI Hub**). * Optionally, you can switch to another product using the dropdown menu. * Click **Get started** to continue. Organization and product selection screen

* Wait for the initialization process to finish. * The system automatically provisions your **company**, **organization**, and **account** in the background. * After provisioning, you will be automatically redirected to your **UDI Hub Dashboard** of the Production Environment. * You can start exploring the system, access the **Quick Start Guide**, or configure your settings.

You can use your free trial for 14 days. Start by exploring the Quick Start Guide and configuring your company and organization settings within UDI Hub. # Manage Team Members Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/manageteam How to invite and manage team members in your organization. * Navigate to the **Settings** section in the sidebar. * Click on **Team** to view and manage your organization's members. * In the **Team Members** section, enter the email address of the person you want to invite. * Select the appropriate role (**org:member** or **org:admin**) from the dropdown. * Once both fields are filled, the **Invite Member** button becomes active. Invite new member

# Manage Organization Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/organizationonboarding Organization Settings – Manage Legal Manufacturers and Market Assignments Keep your organization’s legal manufacturer information up to date and assign responsibilities for different markets and authorities. Centralized management helps you stay compliant and organized, especially when expanding into new markets. * In the sidebar, go to **Settings** and select **Organization**. * Here you can view and manage all legal manufacturers and their market assignments. Application

# Quick Start Guide Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/quickstartguide Learn how to set up your system to be submission ready. Follow the steps below to get started quickly. Each step includes a direct link to the relevant section for more details. Learn how to start your free 14‑day trial of UDI Hub. Set up and manage all key information for your organization and manage members. Invite and manage your team members who should have access to the application. Download the official Excel templates used for bulk data import and prepare your product data correctly from the start. Upload your Excel templates, validate the imported data, and review validation results before submission. Manage device‑level UDI data and ensure all required attributes are qualified for submission. Handle Basic UDI data objects and their relationships to device entries. Authority onboarding is mandatory to unlock machine‑to‑machine submission capabilities for regulatory agencies. Follow the step‑by‑step guide to complete this process. Step‑by‑step guide to unlock machine‑to‑machine submission functionality. Manage, validate, and send submissions in bulk mode to the respective authority endpoints. # Docu Changelog Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/changelog Keep track of changes and updates. Initial documentation created for UDI Hub. Version 1.0, 1.1, 1.2 were used to set up UDI Connect. UDI Hub now joined with v1.3 the product family. # Info Section & Support Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/infosection Access key resources, stay updated on new features, and connect with support — all from the **Info Section** in the sidebar. ## Getting Started Quickly learn the basics of **UDI Hub**: how to import and validate data, manage your users, use the submission dashboard, and stay compliant with authority‑specific rules. [**Getting Started**](/versions/vers1_3/UDIHub/getting-started/quickstartguide) – Step‑by‑step onboarding and essential guidance to begin working with UDI Hub. *** ## What’s New? Stay informed about the latest product updates, feature enhancements, and compliance support extensions for UDI Hub. [**Release Notes**](https://projektraum36.releasedhub.com/udi-hub/changelog) – Explore all current and upcoming changes at a glance. *** ## Need Help? Visit our support board to ask questions, report issues, or request new features.\ Our support team will assist you with setup, troubleshooting, and ongoing operations. [**Support Desk**](https://projektraum36.atlassian.net/servicedesk/customer/portal/42) – Contact us directly for personalized help. *** For technical or process‑related assistance, always include your **organization name**, **organization id** (Settings Profile) and **environment (Validation / Production)** when contacting support. # Overview Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/introduction # Welcome to the Documentation of UDI Hub Discover **UDI Hub**, a powerful data management system focused on importing, validating, and submitting regulatory UDI data efficiently.\ UDI Hub allows you to handle large-scale data imports using Excel templates, ensures controlled data validation, and enables machine-to-machine submissions to authorities following specific submission logic. Gain a quick overview of UDI Hub. ## Quick Start Guide Learn how to set up your system to be submission ready. Follow the Quick Start Guide to manage all necessary steps and configure your environment for bulk UDI data submissions. Learn how to start your free 14‑day trial of UDI Hub. Set up and manage all key information for your organization and ensure proper allocation of users and data ownership. Invite and manage your team members who should have access to UDI Hub. Step‑by‑step guide to unlock machine‑to‑machine submission functionality and authority connections. ## Explore the User Interface Discover key features and workflows in UDI Hub to efficiently import, manage, and submit your UDI data. Navigate through UDI Hub’s key areas and monitor the status of your submissions and imports. Download the official Excel templates used for bulk data import and define your product data correctly from the start. Upload and validate your data imports directly in UDI Hub and track validation results before submission. Manage device‑level UDI data and ensure all required attributes are qualified for submission. Handle Basic UDI data objects and their relationships to device entries. Manage, validate, and send submissions in bulk mode to the respective authority endpoints. Review all relevant system actions and track changes across imports, validations, and submissions. ## Have Questions or Need Support? We're here to help! Discover user guides, release notes, and access the support section to get the assistance you need. Find helpful resources, release notes, roadmap, and support materials for UDI Hub. # What is UDI Hub? Source: https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/introduction_udihub **UDI Hub** is a cloud-based data management solution developed to efficiently handle and maintain large volumes of UDI information.\ It enables structured data imports, validations, and automated submissions to regulatory authorities through machine-to-machine communication. Designed for operational scalability and regulatory accuracy, UDI Hub helps medical device manufacturers digitize and streamline their global UDI compliance processes.\ Users can easily upload bulk data using standardized Excel templates, perform automated quality checks based on authority-specific rules, and execute mass submissions for multiple markets. The solution provides full traceability for every data change and submission, ensuring audit-readiness and compliance transparency at all times. Hub

# API Key Generation Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/apikey How to generate and manage API keys for authenticating API requests in both Preview and Production environments. * In the sidebar, navigate to **API Keys** under the **Settings** section. * Here you can view, create, and manage all API keys for your organization in both **Preview** and **Production** environments. API Keys overview

* Click the **Create API Key** button in the top right corner. * A dialog will appear where you can define the properties of the new API key. * Provide a **Name** and optionally a **Description** for the key. * Choose the appropriate **Environment** — either **Preview** or **Production**.\ ⚠️ Make sure to select the correct environment, as keys are **only valid for the chosen environment** and cannot be used interchangeably. * Click **Create API Key** to generate your new key. Create API Key popup with environment selection

* After creation, your new API key will appear in a popup window. * **Copy the key immediately**, as it will not be shown again after closing this dialog. * You can create new keys or revoke existing ones at any time if needed. **Important:** Store your API key securely. You will not be able to view it again after closing the popup. API Key created popup

* Once created, your new API key will appear in the keys list. * The list shows key details such as name, environment, and creation date. * You can revoke (temporarily disable) or delete (permanently remove) a key from the Actions menu. API Keys list

* You can also create API keys for the **Production** environment using the same process. * Select **Production** in the Environment dropdown before creating the key. Create Production API Key popup

* You can generate multiple API keys for different environments or use cases. * There is no limit to the number of keys that can be created. * All active keys will be visible in the list. Multiple API keys in list

* To manage existing API keys, open the **Actions** menu next to a key. * **Revoke** temporarily disables the key (it can be reactivated later). * **Delete** permanently removes the key from your organization. Revoke or delete API Key actions

# Docu Changelog Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/changelog Keep track of changes and updates. * Introduction of new endpoints for EUDAMED IVDR and SPP * Download of API Documentation possible Initial documentation of the p36 API specification. # Introduction Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/introduction Overview and guidance for using the p36 API endpoints The UDI Connect API provides endpoints to validate, submit, and monitor UDI data directly from your own systems. All functions are accessible programmatically, enabling automated and efficient handling of UDI-related tasks. Comprehensive documentation describes each endpoint, including request and response formats, authentication, and practical examples. The API is designed to be clear and consistent, making it easy to use for developers. Generate your key for API testing and implementation. **Note:** Current EUDAMED scope covers MDR requirements. IVDR, SPP, and Legacy Devices will follow. # Get submission status Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/submission-status/get-submission-status get /api/v1/submission/status Retrieve the current status of a submission request by a requestId or device/deviceGroup. # EUDAMED IVDR Submit Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/submission/eudamed-ivdr-submit post /api/v1/submit/EU_UDI_IVDR Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). # EUDAMED MDR Submit Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/submission/eudamed-mdr-submit post /api/v1/submit/EU_UDI_MDR Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). # EUDAMED SPP Submit Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/submission/eudamed-spp-submit post /api/v1/submit/EU_UDI_SPP Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). # EUDAMED IVDR Validate Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/validation/eudamed-ivdr-validate post /api/v1/validate/EU_UDI_IVDR Validates UDI device data against the specified data model schema and business rules. This endpoint performs comprehensive validation including schema validation, business rule checks, and data integrity verification without actually submitting the data to regulatory agencies. # EUDAMED MDR Validate Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/validation/eudamed-mdr-validate post /api/v1/validate/EU_UDI_MDR Validates UDI device data against the specified data model schema and business rules. This endpoint performs comprehensive validation including schema validation, business rule checks, and data integrity verification without actually submitting the data to regulatory agencies. # EUDAMED SPP Validate Source: https://docs.udiconnect.io/versions/vers1_3/api-reference/validation/eudamed-spp-validate post /api/v1/validate/EU_UDI_SPP Validates UDI device data against the specified data model schema and business rules. This endpoint performs comprehensive validation including schema validation, business rule checks, and data integrity verification without actually submitting the data to regulatory agencies. # Docu Changelog Source: https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/changelog Keep track of changes and updates. * SRN validation for manufacturer and authorized representative added * Added documentation for eudamed test submission. * Process adjustment for Authorized Representative. Initial documentation of the EUDAMED Onboarding process. # EUDAMED Onboarding Source: https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/eudamed Onboarding Process ## Getting Started with EUDAMED Onboarding In this section you will find a high-level overview of the main steps required for EUDAMED onboarding.\ All detailed instructions, screenshots, and helpful tooltips are available directly in the UDI solution for every single step. Hero Light

Environment Info: EUDAMED onboarding takes place in two environments: the Playground (test) and the Productive environment. SRN Info (Single Registration Number): The same economic operators are used in both environments, but each environment requires a different SRN. *** ## Part 1: EUDAMED Playground Onboarding Before starting this process, please make sure that you have already created your actor within the EUDAMED Productive environment and playground environment. This is the prerequisite to start the Access Point Management and Security Token generation we support in this section. Onboarding 1

* Enter Actor ID/SRN, Role, and Regulatory Actor Name in the Playground table in the p36 UDI Solution. * (If applicable, also provide the Authorized Representative SRN.) * Review your entries to ensure accuracy before proceeding. * Download the 3rd Party Agreement template from the p36 UDI Solution. * Complete your company details and sign the document. * Download the Business Justification template from the p36 UDI Solution. * Complete your company details and sign the document. * In EUDAMED Playground, request a new M2M access point and reference the p36 Access Point. * Upload the signed 3rd Party Agreement and Business Justification, complete contact details, select all UDI/Device services, and submit. * After approval, generate a security token in EUDAMED Playground for the UDI/Device module. * **Copy the token immediately** and enter/save it in the p36 UDI Solution. * In the p36 UDI Solution, start a submission test for each actor and send a UDI-DI to EUDAMED Playground. * When successful, download the Proof of Testing document from the p36 UDI Solution. *** ## Part 2: EUDAMED Productive Onboarding The Proof of Testing document must be available before starting productive access point management! * Playground SRN and Productive SRN are different. * Once the status is set to "Completed", you can start productive submissions. Onboarding 2

* Enter the correct Productive SRN/Actor ID for each actor in the Productive table in the p36 UDI Solution. * Double-check all details to avoid mismatches with the Playground setup. * Download the 3rd Party Agreement template from the p36 UDI Solution. * Complete your company details and sign the document. * In EUDAMED Productive, configure the access point as in Playground, referencing the p36 Access Point. * Upload the 3rd Party Agreement document and Proof of Testing document and wait for EUDAMED approval. * After approval, generate the productive security token in EUDAMED Productive. * **Copy the token immediately** and enter/save it in the p36 UDI Solution. # EUDAMED Test Submission Source: https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/eudamed-test-submission Automated test submission process for verifying EUDAMED connectivity using standard payloads. ## Overview The **EUDAMED Test Submission** automates the submission test process to simplify onboarding.\ Once the key data — **SRN**, **Role**, **Regulatory Actor**, and **Security Token** — are available, the system can execute a background test submission using a predefined payload.\ This minimizes manual effort and ensures that the required **Proof of Testing** is automatically generated. *** * Start by navigating to the **EUDAMED Test Submission** section. * If no economic operators are available yet, click **Add Economic Operator** to create a new entry. Empty economic operator list

* In the pop-up window, provide the following: * **Single Registration Number (SRN)** * **Role** (e.g., Manufacturer, System and Procedure Pack Producer) * **Regulatory Actor Name** * Ensure that all information matches the data registered in EUDAMED. We check the SRN format and country code to define if an Authorized Representative needs to be added as well. System and Procedure Pack Producer outside of EU do not need an Authorized Representative, only manufacturers need to comply. Add new economic operator

* When adding an actor **outside the EU**, an additional field for **Authorized Representative** will appear automatically. * Enter the SRN of the EU-based Authorized Representative. * This information is mandatory for non-EU operators. We check the SRN format and only allow european country codes used for Authorized Representative. Authorized Representative field for non-EU actor

Authorized Representative field for non-EU actor

* After successfully adding the actor, a table entry will appear. * Paste the **EUDAMED Playground Security Token** for the corresponding SRN into the designated field. * The token is **securely stored in the background** and **not visible** afterwards. Security token input for actor

* Once the token is entered, the **Test Submission** button becomes active. * Click the button to start the automatic submission. * The button will display: * **Submission in Progress** while running * **Successful** (green) once the process completes successfully Test submission in progress and success state

Test submission in progress and success state

* After a successful test submission, the system will automatically generate a **Proof of Testing** document. * You can download this document directly from the interface. * It serves as a prerequisite for configuring the access point in the **Productive EUDAMED environment**. Proof of Testing document download

* If a submission fails, you can correct the **SRN** or **Security Token** in the Actions menu. * After updating the details, restart the test submission process. # Introduction Source: https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/introduction Complete authority onboarding for UDI submissions with our guided process. Authority onboarding is required to enable automated machine-to-machine (M2M) submissions using the p36 solution. This process ensures that both your organization and the UDI solution fulfill the technical and regulatory requirements defined by each authority. Procedures and requirements can vary depending on the authority. This documentation describes the steps necessary for onboarding with each authority. > **Note:** This section provides a general overview of the onboarding process. For detailed instructions, please refer to the application. The “Authority Onboarding” section in the sidebar contains authority-specific onboarding settings.