Europe-CE Marking MDR / IVDR

GMDN and EMDN codes research

GMDN & EMDN Code Research Services

Accurate Classification for Medical Devices & IVDs

At Alpine Quality Consultants, we assist medical device (MD) and in vitro diagnostic (IVD) manufacturers in identifying the correct GMDN (Global Medical Device Nomenclature) and EMDN (European Medical Device Nomenclature) codes for regulatory compliance. Proper classification ensures seamless UDI registration, EUDAMED submission, and market approval under EU MDR 2017/745, IVDR 2017/746, and global regulatory frameworks.

What Are GMDN & EMDN Codes?

GMDN (Global Medical Device Nomenclature)

  • Internationally recognized medical device classification system
  • Used for regulatory purposes by health authorities, manufacturers, and notified bodies
  • Required for FDA, UK MHRA, TGA, Health Canada, and global regulatory filings

EMDN (European Medical Device Nomenclature)

  • Official nomenclature system for EU MDR (2017/745) & IVDR (2017/746)
  • Mandatory for EUDAMED registration & regulatory filings in the EU
  • Based on the Italian CND (Classificazione Nazionale Dispositivi medici) system

Our GMDN & EMDN Code Research Services

Code Identification & Classification

  • Determine the correct GMDN & EMDN codes for your device
  • Align with intended use, risk classification, and regulatory requirements
  • Verify compliance with EU MDR, IVDR, FDA, and global regulations

EUDAMED & Global Database Registration

  • Register devices with EMDN codes in EUDAMED
  • Ensure correct GMDN classification for FDA, UK MHRA, Health Canada, TGA, and other markets
  • Avoid regulatory delays due to incorrect code assignments

Gap Analysis & Code Validation

  • Verify existing codes against the latest GMDN & EMDN updates
  • Ensure accuracy for UDI, labeling, and technical documentation
  • Provide alternative codes if required for compliance

Customized Research & Advisory Services

  • Conduct custom research for complex or novel devices
  • Support startups & established manufacturers in regulatory classification
  • Assist in code revisions, updates, and regulatory justifications
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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