The UDI system (PART 1)
Automatic identification and data capture (‘AIDC’)
AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
Unit of Use DI
The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).
Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs.
Configurations include inter alia:
|—||gantries, tubes, tables, consoles and other items of equipment that |
can be configured/combined to deliver an intended function in
|—||ventilators, breathing circuits, vaporizers combined to deliver an |
intended function in anaesthesia.
The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
Human Readable Interpretation (‘HRI’)
HRI is a legible interpretation of the data characters encoded in the UDI carrier.
Packaging levels means the various levels of device packaging that contain a defined quantity of devices, such as a carton or case.
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.
Radio Frequency Identification RFID
RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.
A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems.
Unique Device Identifier (‘UDI’)
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
The word ‘Unique’ does not imply serialisation of individual production units.
The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI.
UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.
2. General requirements
2.1 The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation.
2.2 The manufacturer shall assign and maintain unique UDIs for its devices.
2.3 Only the manufacturer may place the UDI on the device or its packaging.
2.4 Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used.
3. The UDI
3.1 A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.
3.2 Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
3.3 The UDI shall contain two parts: a UDI-DI and a UDI-PI.
3.4 The UDI-DI shall be unique at each level of device packaging.
3.5 If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.
3.6 Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.
3.7 Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.
3.8 The manufacturer shall assign the UDI to a device following the relevant coding standard.
3.9 A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
|(a)||name or trade name,|
|(b)||device version or model,|
|(c)||labelled as single use,|
|(e)||need for sterilization before use,|
|(f)||quantity of devices provided in a package,|
|(g)||critical warnings or contra-indications: e.g. containing latex or |
3.10 Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer’s UDI.
4. UDI carrier
4.1 The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
4.2 In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.
4.3 For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.
4.4 For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.
4.5 When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable.
4.6 If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
4.7 If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.
4.8 The HRI format shall follow the rules of the UDI code-issuing entity.
4.9 If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.
4.10 Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:
|(a)||any type of direct marking would interfere with the safety or |
performance of the device;
|(b)||the device cannot be directly marked because it is not |
4.11 The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
4.12 If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device’s packaging, the placing of the UDI carrier on the packaging shall not be required.
4.13 In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.
4.14 The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.
4.15 Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.
5. General principles of the UDI database
5.1 The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex.
5.2 Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database.
5.3 Appropriate methods/procedures for validation of the data provided shall be implemented.
5.4 Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.
5.5 The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.
5.6 The database shall allow for the linking of all the packaging levels of the device.
5.7 The data for new UDI-DIs shall be available at the time the device is placed on the market.
5.8 Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.