UDI Procedures
One of the new elements introduced by the MDR and IVDR Regulations is the unique product identification system, the UDI System. The UDI is a unique product identifier that ensures the identification and traceability of the medical device and consists of two elements: the UDI-DI, product and manufacturer identifier, and the UDI-PI, production identifier.Additionally, there is a BASIC UDI-DI which is the identifier of the product family to which the specific product belongs.The different UDIs will be placed on different documents and in different parts of the product.The medical device manufacturers must associate with some of the entities accredited by the Commission to grant UDI:a) GS1 AISBL (AECOC in Spain).b) Health Industry Business Communications Council (HIBCC)c) ICCBBAd) Informationsstelle für Arzneispezialitäten – IFA GmbH
At DeviCE Sistemas, we can help you with the configuration and processing of your product's UDI
Once the BASIC UDI-DI is assigned, it must appear in the following documents:• In the EU Declaration of Conformity of the product.• In the Declaration of Conformity of the kit or system for procedures.• In the UDI database of EUDAMED.• In the summary of safety and clinical performance of the product (for class III products and implantables).• Conformity assessment application documents to Notified Bodies.• In the certificate issued by the Notified Body
Generate and Develop the BASIC UDI-DI
The UDI is the code that precisely identifies the model of the medical device. It consists of two parts, a UDI-DI and a UDI-PI.• The UDI-DI is a unique numeric or alphanumeric code of a product model.• The UDI-PI is a numeric or alphanumeric code that indicates the unit of the product.A UDI must be assigned to the following products:• Each medical device of each family must have a UDI code.• Each component considered as a product and commercially available individually will be assigned a UDI, unless the components are part of a configurable product with its own UDI.• Systems or kits for procedures will have their own UDI.• Manufacturers who repackage or relabel products with their own label must retain the UDI of the original equipment manufacturer.• In configurable products, a UDI will be assigned for the entire configurable product and its components.• Software products that are marketed individually or that are products in themselves.
UDI Assignment
Always in human-readable format and machine-readable format (barcode, QR, etc.):• On the product label or on the product and at all higher levels of packaging (excluding shipping containers).• For class I and IIa products packaged and labeled individually, it is not necessary to be on the packaging, but it must be on the upper packaging level. (for example, in the box containing several individually packaged products, it will be placed on the box, but not on each small package).• Reusable products that require cleaning, sterilization, disinfection, or renewal must carry the UDI on the product itself and it must always be visible (except if technologically due to the type of material it cannot be).• For products that need to be assembled to constitute the final product, it will suffice to place it on one of its parts.• Implantables will be marked on the lowest level of packaging, that is, on each individual box or unit package.• Systems or kits for procedures will carry the UDI on packaging or on the product itself. Disposables included in the kit that will not be used individually outside the kit should not carry their own UDI.• For software, it will be placed on a screen easily accessible by the user (for example, an about or more information).• If the software is marketed on hardware (CD, DVD, etc.) it will be placed on this medium.
The UDI Carrier (Where should it be placed?)
The UDI-DI
It must be provided to the EUDAMED database and will be unique at each packaging level. This means that if the product has different packaging levels, there will be different UDI-DI for each level.A new UDI-DI will be required when a change occurs that may cause misidentification of the product or ambiguity in its traceability. In short, a new UDI-DI will be assigned when it changes:o Name or trade name.o Version or model of the product.o Labeled as a single-use product.o Sterile packaging.o Need for sterilization before use.o Quantity of products contained in the packaging.o Critical warnings or contraindications, for example, latex or contains DEHP.• In the case of software, a new UDI-DI will be required when modifiedo The original functionality, for example, modifying algorithms.o The safety or intended use of the IT systemo The interpretation of the datao New interfaces.o New database structureso The operating platformo The architectureo New operational channels• It must be in the EUDAMED database at the time of product commercialization. In case of UDI-DI change, there are 30 days for registration in EUDAMED.
It is the part of the UDI that refers to the production of the medical device. When a batch number, serial number, software identification, or expiration date appears on the labeling, they will be part of the UDI-PI.When the manufacturing date also appears on the labeling, it is not necessary to include it in the UDI-PI. When only the manufacturing date appears on the labeling, it will be used as the UDI-PI. In the case of implantable products, it must have at least the serial number for active implantable products and the serial or batch number for implantables in general.In the case of reusable products, the manufacturer must define the characteristics of the UDI-PI such as the batch or serial number.In the case of configurable products, each configurable product will be assigned a UDI-PI of the configurable product.In the case of software, in the software identification, the manufacturing control mechanism will be considered and will appear in the UDI-PI. Minor software revisions will require a new UDI-PI and not a new UDI-DI.