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  • Identify
    Start selling online
    How many codes do I need?
    Next Generation of Barcodes
    My Product Manager
    Calculate the check digit
    Verified by GS1

    Identify

    • Products (GTIN)
    • Logistic units (SSCC)
    • Coupons (GCN)
    • Medical units (UDI)
    • Legal Entity Identifier (LEI)
    • All identification keys
  • Sectors

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    • FMCG and Foodservice
    • DIY, Garden & Pet
    • Healthcare
    • Transport & Logistics
    • Marketplaces & e-commerce
    • Construction
  • Exchange
    My Product Manager
    GS1 GDSN
    Who uses My Product Manager?

    Exchange

    • Product master data
      • Create product information
      • Download product information
      • Data quality
      • Packaging information
      • Product images
    • Transactional data
      • Electronic Data Interchange (EDI)
      • Harmonized Order to Cash (HO2C)
      • Peppol
    • Data models
      • FMCG & Foodservice
      • DIY, garden & pet
      • Healthcare
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  5. Documentatie Gezondheidszorg sector

Useful documentation Healthcare sector

Here you will find an overview of all manuals and other files that are linked to the Healthcare sector:

Legal Texts and Guidances :

Medical Device Regulation MDR 2017/745

In-Vitro Diagnostic Regulation IVDR 2017/746

Articles:

Be ready for UDI in the EU!

Are you ready for UDI ?

Implementation guides:

Implementation guideline

IMDRF UDI (International Medical Device Regulators Forum)

EUDAMED

FDA

MedTech Europe's Guidance on Basic UDI-DI Assignment

Notified Bodies

Do I need a new GTIN?

GTIN Allocation Rules Standard | GS1 for the Healthcare sector

GS1 General Speficiations - Standards

US FDA UDI regulatory database

GS1 Healthcare acronym decoder

Local Authorities:

FAMHP | Your medicine and health products (Federal Agency for medicines and health products)

BeMedTech (Medical Technologies Belgium)

Videos:

The UDI Implementation at Handi-Move

Basic UDI-DI (English Version)

The Clinical Patient Pathway

Contact the sector helpdesk

+32 2 896 52 14
healthcare@gs1belu.org
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