Software as a Medical Device

Software as a medical device (SaMD) is software that is intended for medical purposes that performs its functions without explicitly being part of the hardware of the device.

Is software considered a medical device?

Software can be considered to be a medical device since it is possible for software to execute some kind of medical function independently of any hardware.

For example, software can perform functions related to:

  • diagnosis;

  • prevention;

  • monitoring;

  • treatment and alleviation of disease or injury;

  • replacement, modification or support of the anatomy or physiological process;

  • supporting or sustaining life;

What is software as a medical device?

The term software as a medical device is defined by the International Medical Device Regulators Forum (IMDRF) as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

SaMD may interface with other medical devices and operate on a general-purpose computing platform. It may also be used in combination with other products, and it can be connected to a physical medical device, into which it is not embedded.

The international standard that governs SaMD is IEC 62304 (Medical device software – Software life cycle processes).

SaMD in the EU

In the EU, software as a medical device is defined in the Medical Device Regulation as “software that is specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device”. The qualification of software is independent of the software’s location or the type of interconnection between the software and a device.

Furthermore, in the MDR, SaMD is assigned a risk classification as follows:

  • Software intended to provide information that is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

    • death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or

    • a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

  • Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

  • All other software is classified as class I.

The Medical Device Coordination Group (MDCG) has produce a guidance document on the Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.

SaMD in the USA

In the USA, the Food and Drug Administration (FDA) follows the IMDRF definition and guidelines for handling software as a medical device.

Examples of SaMD

There are many examples of SaMD. Some examples are:

  • an insulin dose calculator based on the glucose level of a patient

  • a mobile app that displays the electrocardiogram signals, probably from a wearable ECG device

  • software used in diagnostics for anomaly detection in ECGs

  • software for planning radio-oncology treatments or tumour contouring software

  • software for computer-aided detection of e.g. breast or skin cancer (image processing software)

  • software for differential diagnosis from blood sample analysis results

Are mobile apps classified as SaMD?

Most mobile apps that simply help you maintain a healthy lifestyle are not SaMDs. However, any app that is intended to be used for one or more medical purposes that perform these purposes without being part of the phone is SaMD.

In addition, apps that control a medical device remotely, using WI-FI or Bluetooth, are also deemed to be SaMD as they are considered to be accessories to the medical device. Regulating agencies categorise an app at the same risk classification level as the medical device the app controls.

For more information

We invite you to watch the MedTech Chat video with ArrowFast Chief Compliance Officer, Rok Hrovatin, where he speaks about software as a medical device according to the new European Medical Device Registration.

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