EUDAMED & UDI
The implementation of the European Database on Medical Devices (EUDAMED) and the Unique Device Identification (UDI) system represents a fundamental shift in how manufacturers manage regulatory information. No longer limited to static documentation, compliance now depends on structured data integrity, traceability, and continuous information exchange with regulators. For many organisations, legacy data sources, inconsistent coding practices, and manual submission workflows have created fragmented, error-prone processes that threaten both compliance and operational efficiency. The increasing emphasis on data accuracy and lifecycle maintenance under MDR and IVDR has made centralised, well-governed systems essential for sustaining regulatory readiness.
Our EUDAMED and UDI consulting services provide manufacturers with a structured approach to achieving and maintaining compliance across all relevant modules and requirements. We begin by performing a comprehensive assessment of your existing product master data, identifying gaps, duplications, and inconsistencies that could lead to registration rejections or audit findings. This diagnostic phase includes mapping data flows across product lifecycle management (PLM), enterprise resource planning (ERP), labelling, and quality systems to establish authoritative data sources and ownership responsibilities.
For EUDAMED readiness, we establish submission workflows that cover Actor Registration, Device Registration, UDI/Device Data, and other applicable modules. We support the creation of submission templates and validation rules, ensuring that data are formatted and verified before upload. Where appropriate, we assist with system-to-system connectivity and automated data exchange setups to reduce manual entry errors and enable timely updates. Our solutions are scalable, accommodating for future regulatory changes or portfolio growth without the need for structural redesign.
Data maintenance is a critical but often overlooked component of compliance. We implement governance frameworks that define clear roles, approval hierarchies, and review cycles for maintaining data accuracy over time. Clients benefit from dashboards and monitoring tools that track data completeness, submission status, and update frequencies, providing continuous oversight and audit traceability.
Our consulting team combines expertise in MDR and IVDR regulatory frameworks with practical experience in data governance and information management. This dual perspective allows us to interpret technical requirements in a way that can be operationalised efficiently within existing business systems. Our methodologies align with international standards such as ISO 13485 and ISO 8000, ensuring both regulatory compliance and data quality excellence.
By implementing a robust EUDAMED and UDI compliance program, organisations not only meet their legal obligations but also gain strategic advantages: improved master data quality, reduced administrative burden, faster audit responses, and enhanced confidence from regulators and partners. Structured data processes also enable more efficient internal reporting and downstream integration with supply chain and post-market surveillance systems.
For further information on how our EUDAMED and UDI services can enhance your regulatory data operations and readiness for MDR and IVDR, please contact our compliance and data governance team.
