OVERVIEW
The European Union has established EUDAMED as the central database for managing medical device and IVD information under the EU MDR and IVDR. Manufacturers placing products on the European market must submit and maintain accurate device data in EUDAMED in accordance with the latest regulatory and technical requirements.
Innovit EUDAMED Connector simplifies the aggregation, management, validation, and machine-to-machine (M2M) submission of device data to EUDAMED. Built specifically for regulated healthcare environments, it supports GAMP 5 system validation principles and addresses the requirements of 21 CFR Part 11 and EU Annex 11.
INNOVIT EUDAMED CONNECTOR
Innovit EUDAMED Connector provides a purpose-built solution for medical device and IVD manufacturers to manage, validate, and submit compliant UDI data to EUDAMED. The solution includes a pre-configured EUDAMED data model with the required data types, attributes, code lists, and data validation rules, enabling organizations to accelerate implementation while maintaining alignment with EUDAMED requirements.
The solution provides native machine-to-machine connectivity using EUDAMED’s AS4 messaging protocol and SOAP XML web services, allowing organizations to securely submit, update, and manage their device records in EUDAMED. Comprehensive audit trails, configurable approval workflows enabled with electronic signature, and complete message exchange history provide full visibility into data changes, approvals, submissions, and EUDAMED responses.
Innovit was the first software vendor to successfully complete EUDAMED machine-to-machine testing with the European Commission in October 2019, and continues to maintain alignment with evolving EUDAMED technical specifications and regulatory requirements.
BENEFITS
Accelerate EUDAMED device submissions
Meet evolving EU MDR and IVDR UDI submission requirements through a purpose-built solution designed specifically for EUDAMED.
Ensure data quality before submission
Validate device information using native EUDAMED business rules to identify issues before submission and reduce errors.
Streamline data governance and approvals
Strengthen data integrity with configurable approval workflows, audit trails, electronic signatures, and complete submission history.
Reduce operational and IT cost
Eliminate custom integrations and manual effort with a purpose-built, M2M submission to EUDAMED that lowers TCO.
Ensure compliance with quality & security standards
Meet regulatory requirements for system quality, security, and data integrity including 21 CFR Part 11, Annex 11 and GAMP 5 system validation standards.
Capability Highlights
Explore the core capabilities that enable efficient, reliable, and compliant device submissions to EUDAMED.
| Category | Features |
|---|---|
| Data Import | Easily onboard device data from your ERP, PLM, PIM/MDM and other source applications |
| Data Maintenance | Out-of-the-box EUDAMED data model with relevant data types, attributes, code lists and data validation rules Simplified data maintenance with configurable web forms and native bulk edit capability |
| Data Governance | Native EUDAMED data validation rules Audit trail and complete version history of data changes Easy-to-configure approval gates enabled with eSignature Complete approval history Granular role-based security Data quality dashboard to track data validation and submission status for EUDAMED |
| Data Submission | Native M2M connectivity to EUDAMED AS4 messaging protocol and EUDAMED SOAP XML support Full visibility to EUDAMED responses and submission status Message log for full message exchange history with EUDAMED |
| Compliance | EU MDR and IVDR UDI requirements 21 CFR Part 11 and Annex 11 GAMP 5 System Validation ISO 27001, SOC 2 and other relevant information security standards Independent USDM audit proving compliance and GxP readiness |
“Innovit EUDAMED Connector streamlines device data onboarding, native data transformation and validation, and machine-to-machine submission to EUDAMED through a single, purpose-built solution.”
Data Flow Models for EUDAMED Submission
With Innovit EUDAMED Connector, customers can leverage pre-packaged and custom data flow models to support their internal business processes for aggregating, maintaining, validating and submitting their device data. The pre-packaged data flow models come in 2-Stage and 3-Stage variations, while also providing a Passthrough option for organizations who do not have users maintaining data in Innovit’s application.
2-Stage Data Flow Model
This model has two distinct stages: maintenance and submission. The maintenance stage comes pre-packaged with the EUDAMED data types, attributes, code lists and data validation rules that customers need to manage and validate their device data. Once the data is validated and approved, it is released to the submission stage where users can submit their clean and validated data to EUDAMED.
Best For:
Organizations maintaining device information directly within Innovit or importing data already aligned with the EUDAMED format.
3-Stage Data Flow Model
This model has three distinct stages: aggregation, maintenance, and submission. The aggregation stage allows users to consolidate and cleanse raw device data from multiple source systems to create a complete device record. The data is then converted into the required EUDAMED format in the maintenance stage and follows the standard data validation and submission process as the 2-stage model.
Best For:
Organizations with multiple source systems that need to aggregate, cleanse, and normalize device data before converting it into the EUDAMED format.
Passthrough Data Flow Model
This model supports a fully automated flow where device data is maintained upstream and only passes through Innovit’s solution for data validation and submission. Device data is automatically imported, mapped and validated against EUDAMED rules, and submitted without manual intervention. Data validation and submission reports are sent back to the source system, where any corrections are made and resubmitted.
Best For:
Organizations with upstream systems where users manage all device data and require a fully automated data validation and submission process.
User Configurable Workflow Model
This model leverages Innovit’s Collabri workflow engine to enable fully configurable, advanced workflow orchestration. Users can design custom data flows with multiple stages, dynamic routing, and role-based tasks using a visual interface. It supports complex approval processes, conditional logic, escalation policies and automated task management to handle sophisticated data management and governance requirements.
Best For:
Organizations with advanced governance, approval, or regulatory review processes requiring configurable workflow orchestration.
Hosting
Different hosting options are available for customers.
Multi-Tenanted
Public Cloud
Shared environment with shared server
Single-Tenanted
Hybrid Cloud
Dedicated environment with dedicated server
Single-Tenanted
Private Cloud
Dedicated environment with dedicated server
