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      • Barcode with GTIN on products
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      • How many codes do you need: roadmap
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  3. 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:

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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