One of the new elements brought about 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, the product and manufacturer identifier, and the UDI-PI, the production identifier.
There is also a BASIC UDI-DI which is the identifier of the product family to which the specific product belongs.
The different UDIs will be placed in different documents and in different parts of the product.
Medical device manufacturers shall be associated with some of the entities accredited by the Commission to grant UDIs:
a) GS1 AISBL (AECOC in Spain).
b) Health Industry Business Communications Council (HIBCC).
d) Informationsstelle für Arzneispezialitäten – IFA GmbH
deviCE can help you in the configuration and processing the UDI of your product
Placement locations of the BASIC UDI-DI
• On the EU Declaration of Conformity of the product.
• In the Declaration of Conformity of the procedure kit or system.
• In the EUDAMED UDI database.
• In the summary of safety and clinical performance of the device (for class III devices and for implantable devices).
• Conformity assessment application documents to Notified Bodies.
• In the certificate issued by the Notified Body.
Assignment of the UDI
The UDI is the code that identifies exactly the medical device model. It is composed 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 indicating the unit of the product.
A UDI must be assigned to the following products:
• Each medical device in each family must have a UDI code.
• Each component considered as a device and commercially available individually shall be assigned a UDI, unless the components are part of a configurable device with its own UDI.
• Systems or procedure kits shall have their own UDI.
• Manufacturers repackaging or relabelling devices with their own label shall retain the UDI of the original equipment manufacturer.
• For configurable products, a UDI shall be assigned for the entire configurable product and its components.
• IT products that are placed on the market individually or are products in themselves.
The UDI carrier (where should it be placed?)
• On the product label or on the product and on all upper levels of packaging (not including shipping containers).
• For Class I and IIa individually packaged and labelled products, it does not need to be on the packaging, but on the upper packaging level (e.g. in the box containing several individually packaged products, it shall be on the box, but not on each individual package).
• Reusable products that require cleaning, sterilisation, disinfection or refurbishment should have the UDI on the product itself and should always be visible (unless technologically not possible due to the type of material).
• On devices that are to be assembled to form the final product, it is sufficient if it is placed on one of its parts.
• Implantable devices shall be marked on the lowest level of packaging, i.e. on each individual box or unit package.
• Systems or procedure kits shall have the UDI on the packaging or on the product itself. Disposables included in the kit that are not to be used individually outside the kit shall not carry their own UDI.
• On the sw, it shall be placed on a display that is easily accessible to the user (e.g. an about or more information).
• If sw are marketed on hardware (CD, DVD, etc.), it shall be placed on this media.
Shall be provided to the EUDAMED database and shall be unique at each packaging level. This means that if the product has different levels of packaging, there will be different UDI-DIs for each level.
A new UDI-DI will be required when there is a change that could lead to misidentification of the product or ambiguity in its traceability. Ultimately, a new UDI-DI shall be assigned when the UDI-DI is changed:
- Name or trademark.
- Product version or model.
- Labelling as a single-use product.
- Sterile packaging.
- Requirement for sterilisation prior to use.
- Quantity of products contained in the packaging.
Critical warnings or contraindications, e.g. latex or contains DEHP.
In the case of sw, a new UDI-DI is required when the following changes occur.
- The original performance, e.g. by modifying algorithms.
- The security or intended use of the computer system
- The interpretation of data
- New interfaces
- New database structures
- The operating platform
- New operational channels
It must be in the EUDAMED database at the time of marketing the product. In case of a change of UDI-DI, 30 days are available for registration in EUDAMED.
This is the part of the UDI that refers to the production of the medical device. Where a batch number, serial number, software identification or expiry date appears on the labelling, it is part of the UDI-PI. Where the date of manufacture also appears on the labelling, it need not be included in the UDI-PI. Where only the date of manufacture appears on the labelling, this shall be used as the UDI-PI.
For implantable devices, at least the serial number for active implantable devices and the serial or batch number for implantable devices in general shall be provided.
For reusable devices, the manufacturer shall define the characteristics of the UDI-PI such as the batch or serial number.
For configurable devices, a UDI-PI of the configurable device shall be assigned to each configurable device.
For sw, the software identification shall consider the manufacturing control mechanism and shall be included in the UDI-PI. Minor revisions to the sw shall require a new UDI-PI and not a new UDI-DI.