(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: 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI. 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. 6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device. 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. 6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI. 6.5. Device Software 6.5.1. UDI assignment Criteria 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: (a) the original performance;
(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: 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI. 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. 6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device. 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. 6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI. 6.5. Device Software 6.5.1. UDI assignment Criteria 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: (a) the original performance;
ENVI_AG(2017)602726_EN.docx