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MQ Traceability Suite UDI EUDAMED Module - Alysidia

MQ Traceability Suite – UDI Module

MQ Traceability Suite – UDI Module and complementary modules allows manufacturers to seamlessly associate UDIs to medical device products, interact with EUDAMED, and maintain full traceability along the supply-chain.

The MQ Traceability Suite guided procedure allows the manufacturer to fill in all information required by EUDAMED and therefore be ready to communicate them without effort.

The EUDAMED required fields for Basic-UDI and UDI-DI can be filled and associated with the products.

The main dashboard of the MQ Traceability Suite allows user-friendly search of products and to easily retrieve the Basic-UDI and the UDI-DI associated.

The platform also allows to manage different packaging levels and create kits and associate respective UDIs.

BOOK A DEMO TO LEARN MORE ABOUT HOW MQ TRACEABILITY SUITE WILL MAKE UDI MANAGEMENT, EUDAMED COMMUNICATION, AND TRACEABILITY AN EASY TASK!

    What is the UDI?

    The UDI is a series of numeric or alphanumeric characters that is made through a globally acknowledged device identification and coding mechanism. It permits the transparent identification of a unique medical device on the market. The UDI is made up of the UDI-DI and UDI-PI. The unique identifier may incorporate information on the lot or serial number and is capable to be implemented everywhere.

    The artifact of a UDI comprises of the following:

    • A UDI device identifier (‘UDI-DI’) relevant to a device, offering access to the information implemented in Part B of Annex VI.
    • A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as stated in Annex VI Part C.

    Assignment/Submission of UDI data/UDI carrier

    • Before placing a device on the market, the manufacturer shall assign to the device and – if applicable – to all higher levels of packaging a UDI.
    • The UDI carrier shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging do not include shipping containers.
    • Before a device is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex V of the device in question is correctly submitted and transferred to the UDI database
    • In some cases, the manufacturer is required to assign a Basic UDI-DI to the device before applying for the conformity assessment (the Notified Body will include a reference to the BASIC UDI-DI in the certificate)

    UDI Label Format according to commonly know GS1 standards

    The device identifiers (DI) and production identifiers (PI) shall be represented by the following applicable application identifiers:

    UDI-DI (portion)

    • (01) – GS1 GTIN

    UDI-PI (portion)

    • (11) – Date of Manufacture
    • (17) – Use By Date
    • (10) – Lot/Batch Number
    • (21) – Serial Number

    Serial Number 

    Corresponds to Application Identifier AI (21) in the DataMatrix Barcode. The Serial Number is used to capture the production identifier ‘Serial Number [SN]. If there is no serial number, a batch number may be applicable.

    • 21 CFR Sub Part K of §820.120 and Sub Part F of §820.60;
    • MDD 93/42/EEC;
    • EU MDR 2017/745 Annex I 23.2(q)
    BOOK A DEMO TO LEARN MORE ABOUT HOW MQ TRACEABILITY SUITE WILL MAKE UDI MANAGEMENT AN EASY TASK!

    RIFD Association and Compliant Label printing

    We are not only provided the perfect tool to manage UDI but you can also use the platform to associate UDI to RFID in order to easily track the products along the supply chain.

    Moreover, with the aid of our selected partners, we provide the best solutions to perform product labeling in compliance with UDI requirements or to laser etch the product directly with the highest quality.

    MDR REGULATION REQUIREMENTS

    UDI is one requirement of a complete revamp of European Medical Device (MDR) and IVD (IVDR) regulations.

    European UDI system implements IMDRF UDI guidance throughout Europe

    Article 27 of MDR
    Article 24 of IVDR

    UDI in MDR

    UDI requirements are defined inside MDR Chapter III – Identification and Traceability of devices

    • Article 27 -UDI system
    • Article 28 -UDI database
    • Annex VI:
      • Part B – core elements to be entered in database
      • Part C – definitions and details of the system
    What is EUDAMED?

    Eudamed is the European Databank on Medical Devices. It’s a protected, web-based gateway that serves as a central store for the exchange of important information for national competent authorities to communicate with the European Commission.

    What information is stored in EUDAMED?

    It depends on the product classification and relevant sections under the old medical device Directive. Eudamed comprises of the following information:

    • The registration of medical devices on EU marker, manufacturers, Authorized Representatives
    • Declaration of conformity
    • A vigilance and traceability system (EU Declaration or statement on ISO certificate)
    • Labeling and instructions (Representation in English)
    • Rationalization of the classification as per Annex IX
    • A copy of ISO 13485 certificate or Evidence of a QMS
    • Reports on Clinical Investigations
    • Additional documentations may be needed, reliant on the particular characteristics of the device.
    What is the Basic UDI-DI?

    The Basic UDI-DI is the primary admittance key for device-associated information in the EUDAMED database and it is stated in pertinent documentation.

    Basic UDI-DI vs GS1

    Global Model Number (GMN), or Basic UDI-DI under the EU Medical Device Regulation
    A product model is a base product design or specification from which a trade item is derived. The trade item inherits major features/functions from the base model. The GS1 Global Model Number (GMN) is the GS1 identification key used to identify product models from which trade items are derived. The GMN comprises the GS1 Company Prefix and a model reference. The model reference is alphanumeric and its structure is left to the discretion of the brand owner who assigns it. The GMN is an up-to-25 length character key (23 characters plus 2 check digits). This element string, once assigned to one product model, SHALL NOT be reissued to another. The GMN SHALL NOT be used to identify a trade item. The manufacturer assigns the GMN (check this guide).

    Which documents contain the Basic UDI-DI references?

    Examples are documents (incorporating certificate of free sale), declaration of conformity for market, clinical performance, safety summary data and technical documentation. It is envisioned to identify and connected devices with the same proposed objective, risk class and important design and manufacturing particulars.

    Alysidia is providing tools and resources to deal with EUDAMED and UDI. And the amazing news here is that all this is offered within a single roof.

    Should you have any more questions, Alysidia will be happy to assist you

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