Regulatory Focus™ > News Articles > Regulating the Cloud: IMDRF Establishes Draft Definition of Standalone Medical Software

Regulating the Cloud: IMDRF Establishes Draft Definition of Standalone Medical Software

Posted 01 July 2013 | By Alexander Gaffney, RAC

The International Medical Device Regulators Forum, a medical device-focused regulators-only successor group to the Global Harmonization Task Force (GHTF), has released a new document for consultation regarding the definition of standalone software used for medical purposes.


The document, Standalone Medical Device Software: Key Definitions, was released on 1 July 2013 and is being coordinated by Bakul Patel of the US Food and Drug Administration (FDA).

As the document explains, "Software for medical purposes is becoming increasingly important and … can appear in many forms and on many computing platforms." For example, some software is embedded into a type of medical device, while others are sold as stand-alone software meant to work on a variety of devices (e.g. mobile devices) or settings (e.g. cloud-based computing or local networks).

A problem that has emerged with respect to regulators is the disruptive pace at which the technology - and its various forms and definitions - is advancing, leading to gaps in regulatory predictability and clarity.

"Existing regulations adequately address public health risks of software when embedded in a traditional medical device," IMDRF writes. "However, existing regulations do not readily translate or address the unique public health risks posed by standalone software nor assure an appropriate balance between patient/consumer protection and promoting public health by facilitating innovation. Existing regulatory controls can have limited applicability when software can be developed, distributed, and accessed in a distributed environment through the internet."

The Document

The aim of IMDRF, then, is to harmonize the various approaches taken by IMDRF member countries and come up with a single definition of standalone software that can be used to harmonize regulatory approaches.

To that end, the document provides a detailed analysis and definition of standalone medical device software (SMDS). To IMDRF, medical device software - which is defined as a medical device -- "may include but are not limited to" the following characteristics:

  • capable of running on general purpose (non-medical purpose) computing platforms, including hardware and software resources such as operating systems (including servers, workstations, or mobile platforms), processing hardware, storage, software libraries, displays, input device and related products
  • not necessary for a hardware medical device to achieve its intended medical purpose
  • may be used in combination (e.g., as a module) with other devices
  • may be interfaced with other medical devices, including hardware medical devices and other standalone medical devices software
  • may include in vitro diagnostic medical devices
  • Software that meets the definition of SMDS and is part of another software, regardless if the other software has a medical purpose or not, is still considered as a SMDS (i.e. medical device). However, software running on a general purpose computing platform that is embedded in a hardware medical device is not SMDS, instead is considered a hardware medical device. (e.g. EKG hardware device that uses windows CE operating system on a general purpose embedded x86 computer is considered an EKG device).

As with regular medical devices, standalone software would only be considered a medical device if it met a "medical purpose," such as aiding in the diagnosis, prevention, monitoring, treatment or alleviation of a disease or injury. The full definition of medical device may be found in GHTF:SG1:N71:2012.

Vestigial Definitions

While the exact definition of SMDS now differs slightly between regions (and in particular with respect to in vitro diagnostics), IMDRF said it would specifically include any device that met the following under its definition of software with a medical purpose:

  • mitigation of a disease
  • provide information for determining compatibility, detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities
  • aid in diagnosis, screening, monitoring, predisposition, prognosis, prediction and determination of physiological status
  • aids for persons with disabilities

Specifically excluded would be any device that helps to disinfect medical devices or devices for in-vitro fertilization or assisted reproduction technologies.

The document also explains what a "software change" is. Because software is more susceptible to errors or security vulnerabilities than the hardware itself, developers may frequently push out updates. IMDRF notes that the changes can include fixes for defects, aesthetic and usability upgrades, security patches, performance enhancements, patches for potential errors, adaptations for new computing platforms or general upgrades to the software's safety, effectiveness, intended use or purpose.

The definition could come to be used by regulators to determine when a change requires a new regulatory submission, or simply a notification-and when.

The full document may be found here. Comments are due by 20 August 2013.

Standalone Medical Device Software: key Definitions

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