# UDI Hub User Guide ## Docs - [Overview](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/introduction.md) - [What is UDI Connect?](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/introduction_udiconnect.md) - [Quick Start Guide](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/quickstartguide.md): 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. - [Start Free Trial](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/freetrial.md): Follow these steps to start your 14-day free trial for UDI Connect. - [Manage Organization](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/organizationonboarding.md): Organization Settings – Manage Legal Manufacturers and Market Assignments - [Manage Team Members](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/manageteam.md): How to invite and manage team members in your organization. - [Environments](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/getting-started/environments.md): Overview of the dual-environment setup in UDI Connect (Preview and Production Environments). - [Home Side](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/features/homeside.md): Get instant insights into your UDI API activity—all in one place. - [API Traces Dashboard](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/features/apitraces.md): Monitor your UDI API activity with real-time analytics, detailed feedback, and a complete request history. - [Info Section & Support](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/infosection.md) - [Docu Changelog](https://docs.udiconnect.io/versions/vers1_3/UDIConnect/info/changelog.md): Keep track of changes and updates. - [Overview](https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/introduction.md) - [What is UDI Hub?](https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/introduction_udihub.md) - [Quick Start Guide](https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/quickstartguide.md): 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. - [Start Free Trial](https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/freetrial.md): Follow these steps to start your 14-day free trial for UDI Hub. - [Manage Organization](https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/organizationonboarding.md): Organization Settings – Manage Legal Manufacturers and Market Assignments - [Manage Team Members](https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/manageteam.md): How to invite and manage team members in your organization. - [Environments](https://docs.udiconnect.io/versions/vers1_3/UDIHub/getting-started/environments.md): Overview of the dual-environment setup in UDI Hub (Preview and Production Environments). - [Home Side](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/homeside.md): Get an overview of your UDI Hub workspace – from key tasks and submission status to global compliance insights. - [Download Templates](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/downloadTemplates.md): Learn how to download and understand the official Excel templates in UDI Hub for preparing and importing UDI data. - [Import Data (Upload and Import Data)](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/uploadTemplates.md): Learn how to upload, validate, and import Excel data files in UDI Hub, including version handling, error management, and import logic. - [Manage Basic UDIs](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/udiManagementBUDIs.md): View, manage, and monitor all Basic UDI-DIs and their assigned devices within UDI Hub. - [Manage Devices](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/udiManagementDevices.md): Track, manage, and review all imported device records, their validation statuses, and registration progress within UDI Hub. - [Details Modal](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/modal.md): Open the Details modal from UDI Management to review version-specific data stored in UDI Hub and key statuses at a glance. - [Submission](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/udiManagementSubmission.md): Learn how to submit data to EUDAMED. - [Submission History Timeline](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/submissionHistory.md): Track the submission progress per registration version, from UDI Hub processing to authority handover, authority response, and publication. - [Change Log (Audit Trail)](https://docs.udiconnect.io/versions/vers1_3/UDIHub/features/changeLog.md): 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. - [Info Section & Support](https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/infosection.md) - [Docu Changelog](https://docs.udiconnect.io/versions/vers1_3/UDIHub/info/changelog.md): Keep track of changes and updates. - [Introduction](https://docs.udiconnect.io/versions/vers1_3/api-reference/introduction.md): Overview and guidance for using the p36 API endpoints - [API Key Generation](https://docs.udiconnect.io/versions/vers1_3/api-reference/apikey.md): How to generate and manage API keys for authenticating API requests in both Preview and Production environments. - [EUDAMED MDR Validate](https://docs.udiconnect.io/versions/vers1_3/api-reference/validation/eudamed-mdr-validate.md): 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 Submit](https://docs.udiconnect.io/versions/vers1_3/api-reference/submission/eudamed-mdr-submit.md): Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). - [EUDAMED IVDR Validate](https://docs.udiconnect.io/versions/vers1_3/api-reference/validation/eudamed-ivdr-validate.md): 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 IVDR Submit](https://docs.udiconnect.io/versions/vers1_3/api-reference/submission/eudamed-ivdr-submit.md): Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). - [EUDAMED SPP Validate](https://docs.udiconnect.io/versions/vers1_3/api-reference/validation/eudamed-spp-validate.md): 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 Submit](https://docs.udiconnect.io/versions/vers1_3/api-reference/submission/eudamed-spp-submit.md): Submit UDI-DI and Basic UDI-DI data to EUDAMED database (productive System). - [Get submission status](https://docs.udiconnect.io/versions/vers1_3/api-reference/submission-status/get-submission-status.md): Retrieve the current status of a submission request by a requestId or device/deviceGroup. - [Docu Changelog](https://docs.udiconnect.io/versions/vers1_3/api-reference/changelog.md): Keep track of changes and updates. - [Introduction](https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/introduction.md): Complete authority onboarding for UDI submissions with our guided process. - [EUDAMED Onboarding](https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/eudamed.md): Onboarding Process - [EUDAMED Test Submission](https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/eudamed-test-submission.md): Automated test submission process for verifying EUDAMED connectivity using standard payloads. - [Docu Changelog](https://docs.udiconnect.io/versions/vers1_3/authority-onboarding/changelog.md): Keep track of changes and updates. ## OpenAPI Specs - [openapiSPP](https://docs.udiconnect.io/versions/vers1_3/api-reference/openapiSPP.json) - [openapiMDR](https://docs.udiconnect.io/versions/vers1_3/api-reference/openapiMDR.json) - [openapiIVDR](https://docs.udiconnect.io/versions/vers1_3/api-reference/openapiIVDR.json) - [openapi](https://docs.udiconnect.io/versions/vers1/api-reference/openapi.json) ## Optional - [Release Notes](https://projektraum36.releasedhub.com/udi-connect/changelog)