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Summary

You must create Unique Device Identification (UDI) codes and register your medical device in the EUDAMED database before placing it on the EU market. This systematic identification and registration process enables complete device traceability, supports post-market surveillance activities, and fulfills mandatory regulatory requirements for market authorization and ongoing compliance monitoring.

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Regulatory Context

Under EU MDR 2017/745 Article 27 and supporting regulations, you must comply with:
  • UDI Device Identifier (UDI-DI) from EU-recognized issuing entities
  • UDI Production Identifier (UDI-PI) with device-specific production information
  • Basic UDI-DI creation for device families and regulatory documentation
  • EUDAMED registration mandatory before market placement per Article 29
  • Single Registration Number (SRN) prerequisite for EUDAMED access
Special attention required for:
  • European Medical Device Nomenclature (EMDN) code accuracy for device classification
  • Software versioning and UDI-PI format requirements for software devices
  • Custom-made device UDI exemptions and alternative identification requirements
  • Legacy device UDI implementation timelines and transition requirements

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Overview

UDI Creation and EUDAMED Registration establish the foundational identification infrastructure that enables complete device traceability throughout the commercial lifecycle while supporting regulatory oversight, post-market surveillance, and supply chain management. This systematic identification process transforms your medical device into a trackable, regulatorily-compliant product that can be effectively monitored and managed across global markets and healthcare systems. UDI Creation Process involves obtaining unique identifiers from approved issuing entities that provide both permanent device identification and production-specific information enabling complete traceability. The UDI creation process requires selection of an appropriate issuing entity such as GS1, HIBCC, ICCBBA, or IFA based on your business needs and global distribution requirements. UDI-DI creation establishes the permanent identifier that remains constant for your device model, while UDI-PI creation provides production-specific information including software versions, manufacturing dates, and batch information that enables precise device tracking and post-market surveillance. Issuing Entity Registration establishes your relationship with approved UDI issuing organizations that provide the technical infrastructure and identifier allocation systems necessary for UDI creation and management. Registration processes vary by issuing entity but typically involve purchasing company prefixes, establishing account relationships, and gaining access to identifier generation tools and databases. Effective issuing entity relationships provide ongoing support for UDI management while ensuring compliance with evolving UDI requirements and technical standards. Basic UDI-DI Creation provides the simplified device family identifier that appears in regulatory documentation and enables systematic device grouping for regulatory and commercial purposes. Basic UDI-DI creation involves applying standardized algorithms to your UDI-DI that generate simplified identifiers for use in Declarations of Conformity, technical documentation, and regulatory submissions. This simplified identification enables efficient regulatory review while maintaining connection to detailed device-specific UDI information that supports traceability and post-market activities. Single Registration Number (SRN) Acquisition provides the prerequisite manufacturer identification that enables access to EUDAMED registration systems and establishes your regulatory identity within EU databases. SRN acquisition involves completing manufacturer registration with EU competent authorities, providing comprehensive company information and regulatory contact details, and undergoing review processes that confirm your legitimacy as a medical device manufacturer. The SRN serves as your unique identifier within EU regulatory systems while enabling access to device registration and ongoing regulatory communication systems. European Medical Device Nomenclature (EMDN) Code Selection ensures accurate device classification that supports appropriate regulatory treatment and effective post-market surveillance activities. EMDN code selection requires systematic analysis of your device’s primary function and clinical application to identify the most specific and accurate nomenclature code that describes your device’s intended use. Accurate EMDN coding affects regulatory classification decisions, post-market surveillance grouping, and vigilance reporting categories while ensuring that your device is properly categorized within European regulatory systems. EUDAMED Device Registration completes the formal registration process that authorizes your device for EU market placement while establishing your presence in European regulatory databases. EUDAMED registration requires compilation of comprehensive device information including technical specifications, regulatory pathway, UDI information, and manufacturer details into systematic database entries. Registration completion enables CE marking application while establishing the regulatory foundation for post-market surveillance, vigilance reporting, and ongoing regulatory communication. Software Version Management addresses the unique challenges of UDI implementation for software medical devices including version control, change management, and production identifier updates that maintain traceability across software evolution. Software UDI management requires establishing systematic procedures for UDI-PI updates that reflect significant software changes while maintaining constant UDI-DI identification for the software platform. Effective software UDI management enables precise tracking of software versions while supporting change control and post-market surveillance activities specific to software medical devices. Registration Maintenance and Updates ensures that UDI and EUDAMED information remains current and accurate throughout your device’s commercial lifecycle while supporting ongoing regulatory obligations and change management requirements. Maintenance activities include systematic review of registered information for accuracy, implementation of change control procedures that update registration data when device modifications occur, and monitoring of regulatory requirements that may affect UDI or registration obligations. Effective maintenance prevents compliance gaps while ensuring that regulatory authorities have access to current and accurate device information. Integration with Quality Management Systems ensures that UDI and registration activities are properly integrated with your overall quality management and regulatory compliance systems. Integration activities include establishing procedures that link UDI creation with product development milestones, implementing change control processes that address UDI and registration updates, and creating traceability systems that connect UDI information with design controls, risk management, and post-market surveillance activities. Effective integration ensures that identification and registration activities support overall regulatory compliance while enabling efficient business operations. Your UDI Creation and EUDAMED Registration activities must demonstrate systematic compliance with identification and traceability requirements while establishing the infrastructure necessary for effective post-market management and regulatory oversight. Well-executed UDI and registration processes enable confident market authorization, support effective post-market surveillance, and provide the foundation for long-term commercial success by ensuring that your devices can be effectively tracked and managed throughout their commercial lifecycle.