By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve**
If it looks like a duck, swims like a duck, and quacks like a duck, then it’s probably a duck… or a medical device!
Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) or purely software (eg mobile medical apps).
In both the US and the EU, standalone software, such as a mobile app, can be a medical device in its own right if it has a medical purpose. This software may operate on a general purpose platform such as a smartphone and typically falls under the jurisdiction of a medical device regulatory authority. Such software is generally called Software as a Medical Device or SaMD.
1. What is Software as a Medical Device (SaMD)?
Software as a medical device (SaMD) is software that’s intended to be used for a medical purpose and that performs this function without being part of a hardware medical device, i.e. it runs on general purpose (non-medical purpose) computing platforms. For example, mobile apps that meet this definition are considered SaMD.
2. How do you determine if your software is a medical device?
This can vary depending on the country of sale, but in most jurisdictions (US, EU), the software is a medical device if the manufacturer (the person who legally markets the product) intends it to be used for a medically related purpose.
In other words, your software is a medical device when its intended use falls under the definition of a medical device.
The intended use is reflected in the specifications, instructions and information provided by the device (software) manufacturer.
3. What’s the definition of a medical device?
In the EU, a ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
– investigation, replacement or modification of the anatomy or of a physiological process,
– control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
In the US, a ‘medical device’ is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
– recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
– intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
– intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
To summarize, your software is a medical device when it is developed for the purpose of:
– diagnosing, curing, mitigating, treating, alleviating, compensating or preventing an injury or a disease;
– providing means and suggestions for mitigation of a disease;
– providing information for determining compatibility, detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities;
– aiding diagnosis, screening, monitoring, determination of predisposition; prognosis, prediction, determination of physiological status.
Examples of standalone medical device software are iPad apps that enhance patient images for diagnostic purposes or analyse ECG signals and give a clinical indication or alert.
Note that software intended by the manufacturer to be used for health and wellness applications (such as sports watches, personal activity trackers) are generally NOT considered medical devices. Also, software that is used for managing general patient data (eg patient records systems) is generally not considered a medical device.
Once you have determined the intended use of your software and concluded that your software is most probably a medical device, the next step is to determine the relevant medical device regulations that apply to your software. This is generally done by performing a device classification and will be the subject of our next article on this topic…
For most device classifications, the software will have to adhere to the same medical device regulations as a regular medical device. This will require, in part, a suitable Software Risk Management process, and in many cases the use of an approved Quality Management System.
Coming soon – articles on device classification, design control, standards and regulatory approval for software based medical devices…
* SoftComply is a developer of Cloud and Server based tools that help companies manage their software risks and implement their quality systems based on the medical device software regulations www.softcomply.com
** Blue Curve is a medical device engineering and safety consultancy company. www.bluecurve.com.au