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What is the UDI?
The UDI is a Unique Identification System for Medical Products that allows for the exact identification of the product and facilitates its traceability throughout the product’s life cycle, from its design and manufacturing or development to after it has been marketed.
Objectives of the UDI
The objective of the UDI is to know everything about the product that is going to be marketed or is already marketed, from who manufactures it, imports it, or who is its Authorized Representative, to what it is made of and when it was manufactured or when it expires.
For all this information to be described in the UDI through a machine-readable code, that is, a barcode or a QR code or similar, (along with the letters and numbers it represents), it is necessary for the Manufacturer to clearly determine three elements: the UDI-DI-BASIC, the UDI-DI, and the UDI-PI.
The UDI-DI BASIC identifies the “family” of products to which the product in question belongs; for example, if we manufacture gloves of different types (sterile and non-sterile) of different sizes (s, m, l, and xl) and different colors (blue and green) the family will be gloves. This means that all these products must have a common principle that identifies them as “gloves.” This UDI-DI BASIC must appear in the EU Declaration of Conformity of the product or kit, in the EUDAMED database, in the product’s safety and performance summary (for class III and implantable products), in the conformity assessment application documents of the Notified Bodies, and in the certificate issued by the Notified Bodies.
What does the UDI consist of?
The UDI itself consists of information related to the product model and the time or conditions of its manufacture, that is, it consists of a UDI-DI and a UDI-PI. The complete UDI will be the barcode or QR along with the letters and numbers it represents, which is placed on the product label and all higher levels of its packaging.
The UDI-DI is a unique numeric or alphanumeric code of a product model, for example, continuing with the glove example, the UDI-DI of the sterile, S, and blue model will be different from the UDI-DI of the sterile M and blue model, etc. Each model will have its specific and unique UDI-DI. And the UDI-DIs of the different packaging forms will also be different, that is, if there are 5 products packed in a box, it will have a different code than if there are 10 products packed in a box, etc.
The UDI-PI is a numeric or alphanumeric code that identifies the production unit of the product, that is, the manufacturing or expiration date, the batch or serial number, the identification of a sw, etc.
When creating these numeric or alphanumeric codes, we cannot do it freely and autonomously. The European Commission has accredited 4 organizations responsible for assigning UDI in medical products:
GS1 AISBL (AECOC in Spain) Health Industry Business Communications Council (HIBCC). ICCBBA Informationsstelle für Arzneispezialitäten – IFA GmbH
Each medical product manufacturer can associate with the organization they find most convenient to thus, according to the chosen organization’s standards, create their UDI codes.
What should the UDI include?
Finally, it should be noted that all information related to the product and that will be in the Unique Identification System UDI must be provided to the UDI database (in EUDAMED). Generally, we can say that the following data must be entered into this database:
The UDI-DI. The quantity of products per package. The BASIC UDI-DI and additional UDI-DIs (that is, all UDI-DIs associated in the same database entry) and the issuing entity providing the UDIs. How the device’s production is controlled, that is, manufacturing or expiration date, batch number, series, etc. UDI-PI. Unit of use UDI-DI: When a UDI is not labeled on the device because it is a custom-made device or for a single patient. A “unit of use” DI will be assigned to establish the device’s traceability with the patient. Name and address of the manufacturer. Issued SRN. Name and address of the Authorized Representative, if applicable. EMDN code. Device risk class. Device trade name. Name or model of the device identifying the UDI-DI-BASIC group to which it belongs. Reference or catalog number. (Additional) product description. Storage and distribution conditions (same as on label and instructions), if applicable. Additional trade names of the device, if applicable. If applicable, single-use device labeling. If applicable, maximum number of reuses. If applicable, sterile labeling. If applicable, needs sterilization before… If applicable, latex content. Label information. Manufacturer’s URL for specific information on instructions, label, etc. Warnings, indications, and contraindications, if applicable. Device status (on the market, no longer on the market, withdrawn, corrective action, etc. Reprocessed use device, if applicable. Indication if the purpose is not medical, if applicable. Name, address, and contact details of the natural or legal person who designed and developed the device (except the manufacturer), if applicable.
There are different guides and monographs to assist in establishing UDI codes. From DeviCE Sistemas we can clarify what you need in this area and guide you in obtaining the UDIs.