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ANNEXES

ANNEX VIU.K. INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM

PART CU.K. THE UDI SYSTEM

6.Rules for specific device typesU.K.

6.1.Implantable devices:U.K.

6.1.1.

Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);

6.1.2.

The UDI-PI shall have at least the following characteristics:

(a)

the serial number for active implantable devices,

(b)

the serial number or lot number for other implantable devices.

6.1.3.

The UDI of the implantable device shall be identifiable prior to implantation.

6.2.Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between usesU.K.

6.2.1.The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.U.K.

6.2.2.The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.U.K.

6.3.Systems and procedure packs as referred to in Article 22U.K.

6.3.1.The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.U.K.

6.3.2.Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.U.K.

Exemptions:

(a)

individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;

(b)

devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.

6.3.3.Placement of the UDI carrier on systems or procedure packsU.K.

(a)

The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.

(b)

The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.

6.4.Configurable devices:U.K.

6.4.1.A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.U.K.

6.4.2.The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.U.K.

6.4.3.A configurable device UDI-PI shall be assigned to each individual configurable device.U.K.

6.4.4.The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.U.K.

6.4.5.Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.U.K.

6.5.Device SoftwareU.K.

6.5.1.UDI assignment CriteriaU.K.

The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.

The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.

6.5.2.A new UDI-DI shall be required whenever there is a modification that changes:U.K.

(a)

the original performance;

(b)

the safety or the intended use of the software;

(c)

interpretation of data.

Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

6.5.3.Minor software revisions shall require a new UDI-PI and not a new UDI-DI.U.K.

Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency.

Minor software revisions shall be identified by a manufacturer-specific form of identification.

6.5.4.UDI placement criteria for softwareU.K.

(a)

where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software;

(b)

the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an ‘about’ file, or included on the start-up screen;

(c)

software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API);

(d)

only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.;

(e)

the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.