Europe-CE Marking MDR / IVDR

UDI Implementation Guidance

UDI Implementation Guidance for Medical Devices & IVDs

Ensure Compliance with EU MDR, IVDR & Global UDI Regulations

At Alpine Quality Consultants, we provide expert guidance on Unique Device Identification (UDI) implementation, ensuring compliance with EU MDR 2017/745, IVDR 2017/746, US FDA UDI Rule, and other global regulatory frameworks. Our team helps medical device (MD) and in vitro diagnostic (IVD) manufacturers navigate UDI requirements, streamline data submission, and achieve full compliance with regulatory databases like EUDAMED and GUDID.

What is UDI?

Unique Device Identification (UDI) is a standardized system used to uniquely identify medical devices throughout their lifecycle. It enhances traceability, patient safety, and post-market surveillance (PMS).

  • Mandatory under EU MDR & IVDR for all devices entering the European market
  • Required for FDA compliance under 21 CFR Part 830
  • Global adoption by regulators in Europe, USA, China, Japan, and more

Our UDI Implementation Services

UDI Strategy & Compliance Assessment

  • Identify applicable UDI requirements based on device classification
  • Assess compliance with MDR, IVDR, FDA, and other regulatory bodies
  • Develop a customized UDI implementation plan

UDI Code Generation & Labeling Support

  • Assign UDI codes based on GS1, HIBCC, or ICCBBA standards
  • Ensure UDI labeling & direct marking meet regulatory requirements
  • Validate barcode readability & compliance

EUDAMED & GUDID Data Submission

  • Register devices in EUDAMED (EU UDI Database)
  • Submit UDI data to FDA GUDID (Global UDI Database)
  • Ensure structured data entry & validation

UDI Data Management & Maintenance

  • Establish a UDI data governance system
  • Maintain up-to-date UDI records & regulatory filings
  • Implement UDI tracking & post-market monitoring

UDI Training & Internal Process Integration

  • Train teams on UDI compliance, labeling & regulatory reporting
  • Integrate UDI into QMS & product lifecycle management
  • Ensure alignment with supply chain & distribution partners
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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