Software in Medical Devices, by MD101 Consulting

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Unique Device Identification for software medical device - part 2

This is the second part of our discussion about Unique Device Identification (UDI).

What for software?

FDA proposed rule

The FDA proposed rule has a specific section for standalone software.
The basic idea is that standalone software can be electronically delivered, or that once it is copied in hard-disk, the package (CD-ROM + user manual) often gets lost. For these reasons, it's necessary to have a user interface that allows retrieving the UDI of the standalone software, like a splash screen or Help/About window.
The proposed rule doesn't give any requirement about the construction of the UDI. But software configuration management rules can easily generate identifiers, which respect UDI characteristics.

IMDRF draft guidance

The IMDRF added a similar section in its draft guidance version 2, inspired of FDA guidance. At the bottom of this document, we find:

  • Rules to assign DI-UDI and PI-UDI to software versions,
  • Rules to place labels in software GUI, or through software API if software is GUI-less.

Compared to FDA proposed rule, the IMDRF guidance adds a rule of construction composed of major version and minor version of software. This rule is still in draft state and should be modified until it is released in its final version.

EC recommendation

There's nothing about standalone software in EC recommendation. But, given the ongoing effort of international harmonization, needless to say that sooner or later, these requirements will be adapted to EC regulations.

Consequences for software manufacturers

When these rules come into force, software manufacturers will have to put in place a UDI system, with barcodes and interoperability capabilities, like any other manufacturer.
In the IMDRF guidance, the specific section about standalone software adds the requirement to have:

  • a window in the GUI, which contains all information to identify software,
  • or, for GUI-less software, an API to query the software UDI.

These rules have an impact on software design. They shouldn't break the design of existing software. Manufacturers of standalone software usually provide a help/about window or a GetVersion API in their products. This is a good practice in software industry.

Although these rules are still in draft state, we can expect that they won't change the lifecycle of software, and the way software is uniquely identified. UDI will be a bit of software design (GUI to display the UDI or an API to query the UDI) and a bit of software configuration management (A task that software manufacturers already do).

On the contrary, UDI will be a lot of data management and interoperability with external systems (the databases owned by authorities), something that all manufacturers will have to implement. Probably at their own expense.

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