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Unique Device Identifier - UDI - Public Health

    https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_en
    The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of …

Unique Device Identification (UDI) System - Public Health

    https://health.ec.europa.eu/system/files/2020-09/md_faq_udi_en_0.pdf
    The new system will be applied to all medical devices except custom-made and performance study/investigational devices and is substantially based on internationally …

Unique Device Identification (UDI) - Healthcare | GS1

    https://www.gs1.org/industries/healthcare/udi
    What is UDI? A Unique Device Identification (UDI) system is intended to provide single, ...

UDI requirements for medical device manufacturers in the EU

    https://medicaldevicehq.com/articles/udi-requirements-medical-device-manufacturers-eu/
    UDI will be applicable to all manufacturers of medical devices in the EU. If you would like to know more about the UDI requirements, please take a look at the video …

Overview of the EU Basic UDI-DI

    https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/overview-of-the-eu-basic-udi-di/
    The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and …

UDI Beginners Guide: Unique Device …

    https://easymedicaldevice.com/udi/
    The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new things that come with the new EU MDR 2017/745 and …

What are the relevant dates and deadlines? – EU UDI …

    https://eu-udi.zendesk.com/hc/en-150/articles/360019388777-What-are-the-relevant-dates-and-deadlines-
    The obligation for submission of UDI data in the EUDAMED database: this obligation applies 24 months after EUDAMED has become fully functional; The obligation …

Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    Medical devices legislation The Regulations on Medical Devices ( Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices ( Regulation (EU) …

Quick reference guide - global medical …

    https://www.rimsys.io/blog/quick-reference-guide-global-udi-requirements-and-timelines
    There are two components to a medical device UDI: the UDI device identifier (UDI-DI) and the UDI production identifier (UDI-PI). The UDI is presented as a barcode label (human …

Unique Device Identification System (UDI System) | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
    Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency's UDI system, on device labels, device packages, and in some instances, directly on the …



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