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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.
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:
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:
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.
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.
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 requirements are defined inside MDR Chapter III – Identification and Traceability of devices
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.
It depends on the product classification and relevant sections under the old medical device Directive. Eudamed comprises of the following information:
The Basic UDI-DI is the primary admittance key for device-associated information in the EUDAMED database and it is stated in pertinent documentation.
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).
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.