Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

6. Rules for specific device types

6.1. Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or refurbishing between uses

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

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

6.2. Device software

6.2.1. 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.

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

(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.

6.2.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI:

• 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.

6.2.4. UDI placement criteria for software

(a)

where the software is delivered on a physical medium, for example via a 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.