Software in Medical Devices, by MD101 Consulting

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IMDRF published a proposed document on standalone software definitions

At be beginning of june 2013, the International Medical Devices Regulators Forum (IMDRF) published a proposed document on standalone software definitions.
The goal of this document is to harmonize the key definitions related to standalone software.

It contains proposed definitions of:

  • Standalone medical device software,
  • Medical purpose for software,
  • Software Changes,
  • Standalone Medical Device Software manufacturer, and
  • Intended use / intended purpose.

The document can be downloaded here on IMRDF website.

There are today strong differences of regulatory approaches towards standalone software. For example, the Medical Devices Data Systems (MDDS) are medical devices according to the FDA, whereas they may not, according to the European MEDDEV 2.1/6 Guidance.

Reading the definition of medical purpose, I understand that, according to lines 158 to 160, MDDS are medical devices. The IMDRF definition of standalone software medical device looks closer to FDA's definition that European definition.

Definitions are useful to define what is what. But they don't make the rules (who has the right/obligation to do what). These definitions are intended to serve as a foundation for further IMDRF work, says the IMDRF. We can expect other documents to be released in the coming months by the IMDRF about standalone software.

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