Following the implementation of the Unique Device Identifier (UDI) regulation in America, other countries and regions are now fasttracking the adoption of medical device regulations in their respective jurisdictions. Next one up with significant implications is the European Union which has set a compliance date of May 2020. The EU’s Medical Device Regulation (MDR) went into effect in May of 2017 to establish greater control and transparency on the quality and safety of medical devices manufactured or imported to the EU. A key  component of the MDR regulation is the European Database on Medical Devices (EUDAMED) that collects certain medical device data from manufacturers and makes them accessible to the public. Unlike the FDA’s Global Unique Device Identification Database (GUDID), EUDAMED requires more extensive data including unstructured information related to clinical investigations, safety & performance studies, vigilance and market surveillance.

As such, the UDI data required by the FDA is just one of six modules covered in EUDAMED, which are:

  • Actor Registration
  • Device Registration (UDI)
  • Notified Bodies & Certificates
  • Clinical Investigations & Performance Studies
  • Vigilance
  • Market Surveillance

As stakeholders await the final technical specifications from the European Commission on UDAMED, manufacturers are scrambling to understand the requirements, collect the relevant data and establish a process to submit data to EUDAMED under pressing time constraints. Innovit’s MDR Connector solves these challenges by allowing device manufacturers to implement a “global system and unified process” that is fully integrated with internal systems for submitting both structured and unstructured data to EUDAMED.


Innovit’s MDR Connector is a GAMP5 validated, 21 CFR Part 11 and Annex 11 compliant solution that allows device manufacturers to submit structured and unstructured data to EUDAMED**. Manufacturers automatically get a pre-packaged list of device attributes, code lists and validation rules for submission to EUDAMED. Furthermore, manufacturers can import, associate and submit regulatory documents that are linked to a device through the Basic UDI Device Identifier. Innovit’s MDR Connector also automates the submission of data in the specific data format and messaging protocol required by the regulatory agency (i.e. AS4 protocols and SOAP XML). A complete message exchange history is also stored in Innovit’s solution to provide data stewards in Regulatory Affairs and Quality Assurance with full visibility and traceability of their data submission history.

* Solution pending technical specifications from the European Commission
** Development of MDR Connector for relevant Modules is prioritized based on the volume of data submitted with the UDI Module being first priority

“Innovit Multi-Domain Master Data Management delivers key business outcomes through trusted master data.”


Data Import Centralized structured and unstructured data
Data Maintenance Pre-configured EUDAMED UDI attributes
Pre-configured EUDAMED UDI attribute code lists
Pre-configured EUDAMED UDI attribute validation rules
Management of Basic UDI DI (BUDI) and Single Registration Numbers (SRNs)
Risk classification management
Data Governance Data validations
Workflow processes for data enrichment and approval
Granular role-based security
Audit trail for data and message exchange history
eSignature for full approval traceability
Data Submission EUDAMED
AS4 protocols and SOAP XML


Different hosting options are available for customers.

  • Hybrid Cloud: Shared server but dedicated environment
  • Public Cloud: Multi-tenanted with shared server and shared environment
  • Private Cloud: Dedicated server and dedicated environment


  • Achieve compliance with EUDAMED requirements
  • Centralize data validation and submission
  • Enhance data quality and governance
  • Reduce operational and IT cost