UDI assignment

The UDIs are issued by issuing entities. Issuing entities operate a system for the assignment of the UDIs.

Each level of packaging must have a distinctly different UDI.

The UDI shall be assigned at the system level of the software. Only software that is commercially available on its own and software that constitutes a device in itself shall be subject to that requirement. The software identification shall be considered the manufacturing control mechanism and shall be displayed in the UDI-PI. UDI requirements for software are laid down in Annex VI Part C of the two medical device Regulations.

A dedicated guideline with additional information on this aspect is available at MDCG 2018-5 guidance document.

No, a UDI-DI can only be linked to one Basic UDI-DI.

Secondary DI is issued from a different issuing entity than the primary DI.

Legacy devices shall be registered in EUDAMED in two cases:

The Units of use DI is an identifier for an individual medical device. It is assigned when a UDI is not labelled at the level of the device unit of use (e.g. several units in the same package).

Higher levels of packaging shall have their own unique UDI. Shipping containers shall be exempted from the requirement.

It is not possible to have a different issuing entity between a direct marking UDI-DI and a UDI-DI for the same device.

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. The UDI-DI shall be unique at each level of device packaging.

This mandatory, fixed portion of a UDI identifies a manufacturer’s specific product and package configuration.

The Unit of Use DI (UoU DI) is an identifier (following the UDI rules of the chosen issuing entity) assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to provide a UDI-DI to identify a device used on a patient when a UDI-DI does not appear on the label of the device.

For example: If the lowest base packaging level with a identified UDI, has a device count greater than 1, a Unit of Use DI (UoU DI) shall be assigned.

If the device is not directly marked and the base quantity of the device is greater than one, the Unit of Use DI shall be provided within EUDAMED.

The Issuing entity for the Unit of Use DI Code is the same as the UDI-DI.

The same Unit of Use DI can be used for several Devices.

According to Annex VI, Part C, Section 1, the Unit of Use-DI is defined as follows:

The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not placed 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.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424

Please refer for further details to:

“Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices” (May 2021; MDCG 2021-10)

https://ec.europa.eu/health/system/files/2021-06/md_2021-10_en_0.pdf

A Basic UDI-DI is a primary identifier for medical devices having the same intended purpose, the same risk class and the same essential design.

A Basic-UDI-DI is also a general access key for EUDAMED, identifying all data entries for the devices covered by that Basic UDI-DI.

The Basic UDI-DI does not appear on any medical device labeling and is therefore independent of any packaging levels.

The Basic UDI-DI should be identified on the:

According to MDCG-2019-05, Legacy devices are to be registered in EUDAMED without a Basic UDI-DI and UDI-DI.

For registration in EUDAMED, EUDAMED will assign a EUDAMED DI and a EUDAMED ID to the device instead of the Basic UDI-DI and UDI-DI respectively. This will allow the system to work and to keep the EUDAMED design as close as possible to the MDR design. The EUDAMED DI and EUDAMED ID will be unique for a given legacy device.

The registration deadlines for these devices are those referred to in Article 123(3)(e): 18 months after the date of application provided that EUDAMED is fully functional on time, or 24 months after publication of notice referred to in Article 34(3).

In the event of a serious incident or field safety corrective action to be reported during the 18/24 months referred to in the paragraph above, if the Legacy devices have not already been registered in EUDAMED, they must be registered when the serious incident/field safety corrective action is reported.

Here the link to the MDCG 2019-05 document:

https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_5_legacy_devices_registration_eudamed_en.pdf

The UDI-PI is created to provide information about the production control mechanism defined by the manufacturer for a specific device.

According to Annex VI, Part C, Section 1 of the MDR (2017/745) the UDI-PI includes:

The manufacturer is responsible for defining the correct UDI-PI information applicable for traceability and control of manufacturing procedures. Annex VI, Part C provides more details regarding the UDI-PI information to be provided for special devices, such as active implantable devices or software-standalone devices.

According to Annex VI, Part C, Section 3.5 of the MDR, the minimum requirements for displaying the PI information are as follows:

Result: If both serial number and lot number are provided on the label, both shall also be provided in the UDI-PI.

Rational: The manufacturer has decided to use both numbers on the label for traceability and control of production, since this is required for that specific device. Including both pieces of information in the UDI-PI helps with traceability on the market, making it possible to scan the device within the logistics chain.

“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.”

as stated in Annex VI, Part C, Section 1 of both regulations (MDR/IVDR).

The Unit of Use DI (UoU DI) is an identifier (following the UDI rules of the chosen issuing agency) assigned to individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to identify a device used on a patient when a UDI-DI does not appear on the label of the device.

For example: If the lowest base packaging level with an identified UDI, has a device count greater than 1, a Unit of Use DI (UoU DI) should be assigned.

In case the device is not directly marked and the base quantity of the device is greater than one, the Unit of Use DI should be provided within EUDAMED.

The data entry in EUDAMED for the Unit of Use DI can be identified in the following document:

UDI Devices - user guide. Please see 3.1.3 Step 3: UDI-DI identification information.

The manufacturer is responsible for assigning the Basic UDI-DI and UDI-DI to the device including to the defined packaging levels.

This is defined in Article 27(3) of MDR/Article 24(3) of IVDR:

“Before placing a device, other than a custom-made/ performance study device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.”

For any distribution or importer activities, there is no need for changing the UDI related information.

In case the same medical device (with the same indented purpose and same design characteristics) is packaged in different quantities, the Basic UDI-DI remains the same as it serves to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics. It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item. For more details, please review the UDI Devices user guide and the Guidance on Basic UDI-DI and changes to UDI-DI.

A kit is defined in Article 2(11) of IVDR (2017/746) as:

“a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof […]”.

For the purposes of IVDR, in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices are referred to as devices. In addition, Annex VI of IVDR clarifies that:

“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.”

Remember that kits shall be assigned and bear their own UDI.

Given the above-mentioned definitions, and since an accessory is defined as a device, it should follow the UDI requirements of IVDR (2017/746). The UDI requirements are applicable for all devices which are made commercially available on their own right. The UDI information must be provided on the kit. If the accessory is not made commercially available outside the kit, there is no need to identify the UDI on the accessory if the device is part of the kit packaging (where the UDI is assigned for).

If the components (devices) are only placed on the market as part of a kit, and are not placed on the market as devices in their own right, then the kit itself, and not the component, must be registered in EUDAMED.

If the device is not commercially available in its own right, there is no need to have the UDI information on the labeling.

An accessory for a medical device means an article which, whilst not being itself a medical device or an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular medical device or in vitro medical device to specifically enable it to be used in accordance with its intended purpose. As defined in Article 2 of both regulations: MDR 2017/745 and IVDR 2017/746, an accessory for a medical device can be intended to specifically and directly assist the medical functionality of the medical device or in vitro medical device in terms of its intended purpose.

Therefore, an accessory can be used with one or several medical devices (in vitro medical devices) according to the intended purpose of the accessory defined by the legal manufacturer. If the accessory is placed on the market separately on its own right, the UDI requirements of the applicable regulation must be fulfilled (labeling and registration).

If the accessory is placed on the market as part of a system/procedural pack (as defined in Article 22 of MDR) or as a kit defined in Article 2 of IVDR only, the UDI labeling and registration are not required, since the accessory is not placed on the market in its own right.