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Is Your Software a Medical Device?

Software qualifies as medical device software (MDSW) if it fulfills the definition of software according to MDCG-11 guidance and the definition of a medical device according to Article 2(1) of Regulation (EU) 2017/745 – MDR.


Medical Device Software (MDSW) can:

  1. directly control a (hardware) medical device (e.g. radiotherapy treatment software),

  2. provide immediate decision-triggering information (e.g. blood glucose meter software), or

  3. provide support for healthcare professionals (e.g. ECG interpretation software).

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Types of Software that are considered as Medical Device Software (MDSW):

​1. Software that may be independent and having its own intended medical purpose.

Examples:

  • MDSW that uses maternal parameters such as age, concentration of serum markers and information obtained through foetal ultrasound examination for evaluating the risk of trisomy 21.

  • MDSW that receives measurements from transrectal ultrasound findings, age, and in vitro diagnostic instruments and calculates a patient’s risk of developing prostate cancer.

  • Mass Spectrometry MDSW intended to analyse LC-MS/MS data to be used for microorganism identification and detection of antibiotic resistance.

  • MDSW smartwatch app, which is intended to send alarm notifications to the user and/or health practitioner when it recognises irregular heartbeats for the purpose of detecting cardiac arrhythmia

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2. Software that drives or influences a (hardware) medical device and also has a medical purpose

Examples:

  • Melanoma image analysis software intended to drive a near-infrared laser light scanner.

  • MDSW intended to measure and transmit blood glucose levels, calculate insulin dose required and
    drive the insulin pump to administer the calculated dosage (closed loop insulin delivery system).

 

3. Software that operates regardless of its location (e.g. operating in the cloud, on a computer, on a mobile phone, or as an additional functionality on a hardware medical device).

Example:

  • MDSW that is intended to operate a point of care test from a remote location.

 

4. Software intended to be used by healthcare professionals or laypersons (e.g. patients or other users).

Example:

  • MDSW that provides insulin dose recommendations to a patient regardless of the method of delivery of the prescribed dose, whether via an insulin pump, insulin pen or insulin syringe.

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5. Software that is driving or influencing the use of a medical device, either as a part/component of a device or as an accessory for a medical device.

Examples:

  • Software that is intended to be used to operate a clinical chemistry analyser.

  • Software with built-in electronic controls for IVD quality control procedures. These quality control procedures are intended to provide users with assurance that the device is performing within specifications

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Software, intended for non-medical purpose, are NOT considered as Medical Device Software (MDSW):

Examples:

  • Hospital Information Systems that support the process of patient management e.g intended for patient admission and scheduling patient appointments,
    for insurance and billing purposes.

  • Electronic patient record systems that are intended to store, transfer and archive electronic patient records.
  • A Clinical Information System/Patient Data Management System that primarily intended to store and transfer patient information generated in association with the patient’s intensive care treatment (e.g. intensive care units).
  • Software-based system intended for ambulance services to store and transfer pre-hospital ECG of patients to doctors at remote location.
  • Communication system is intended for general purposes, and is used for transferring both medical and non-medical information.

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