European Commission Offers Guidance on Standalone Software as a Medical Device or IVD
The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic (IVD) or neither.
As the commission notes, standalone software can directly control an apparatus (e.g. radiotherapy treatment), provide immediate decision-triggering information (e.g. blood glucose meters) or provide support for healthcare professionals (e.g. ECG interpretation), though not all such software programs can be regulated as a medical device or IVD.
The guidance outlines six steps to make such a determination for devices:
- Decision step 1: Determine if a product is software according to the definition of this document.
- Decision step 2: If the software is incorporated into a medical device rather than standalone software, it must be considered as part of that medical device in the regulatory process of that device. If it is standalone software, proceed to step 3.
- Decision step 3: If the software does not perform an action on data, or performs an action limited to storage, archival, communication, “simple search” or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device. Altering the representation of data for embellishment purposes does not make the software a medical device. In other cases, including where the software alters the representation of data for a medical purpose, it could be a medical device.
- Decision step 4: Software for the benefit of individual patients is software intended to be used for the evaluation of patient data to support or influence the medical care provided to that patient. Examples of software not considered to be for the benefit of individual patients are those which aggregate population data, provide generic diagnostic or treatment pathways, scientific literature, medical atlases, models and templates as well as software for epidemiologic studies or registers.
- Decision step 5: If the manufacturer specifically intends the software to be used for any of the purposes listed in Article 1(2)a of Directive 93/42/EEC, then the software shall be qualified as a device. However, if only a non-medical purpose is intended by the manufacturer, such as invoicing or staff planning, it is not a medical device. Note: A task such as emailing, web or voice messaging, data parsing, word processing, and back-up is by itself not considered as being a medical purpose, according to Directive 93/42/EEC.
- Decision step 6: If the software is an accessory to a medical device, it is not a medical device, but it falls under Directive 93/42/EEC. The legal definition of 'putting into service' requires that a device is made available to the final user/operator as being ready for use on the Community market. Software made available to the user over the internet (directly or via download) or via in vitro diagnostic commercial services, which is qualified as a medical device, is subject to the medical devices directives.
In addition, standalone software fulfilling the definition of medical device and intended to be used for the purpose of providing information derived from in vitro examination of a specimen derived from the human body falls under Directive 98/79/EC.
Provided that standalone software is intended specifically by its manufacturer to be used together with an IVD medical device to enable that device to be used in accordance with its intended purpose, this standalone falls under the scope of the IVD Directive and shall be treated as an IVD device in its own right (ie. analysis and interpretation of the optical density delivered by an ELISA reader, line or spot pattern of a blot).
For IVDs, the guidance says that, “If the information provided by the software is based on data obtained from IVD medical devices only, the software is an IVD medical device or an accessory of an IVD medical device. If data are obtained from both IVD medical devices and from medical devices are analysed together for the purpose of providing information according to the definition of an IVD medical device, this software is an IVD medical device (e.g. evaluation of the risk of Trisomy).”
For standalone software intended for use in combination with other devices or equipment, the whole combination must be safe and must not impair the specified performances of the devices, the commission says.
Examples
In the guidance, the commission offers several examples of what types of standalone software should and should not be considered devices or IVDs.
For instance, hospital information systems (systems that support the process of patient management and are intended for patient admission, for scheduling patient appointments, for insurance and billing purposes) are not qualified as medical devices.
But if they are computer-based tools combining medical knowledge databases and algorithms with patient-specific data and are intended to provide healthcare professionals and/or users with recommendations for diagnosis, prognosis, monitoring and treatment of individual patients, then they would be considered medical devices.
For example, radiotherapy treatment planning systems, which are intended to calculate the dosage of ionizing irradiation to be applied to a specific patient, are considered to control, monitor or directly influence the source of ionizing radiation and qualify as medical devices, according to the commission.
In addition, drug (e.g.: chemotherapy) planning systems intending to calculate the drug dosage to be administered to a specific patient also qualify as medical devices.
Clinical information systems (CIS) or patient data management systems (PDMS) that store and transfer patient information generated in association with the patient’s intensive care treatment (and usually containing patient identification, vital intensive care parameters and other documented clinical observations) do not qualify as medical devices. But modules that are intended to provide additional information contributing to diagnosis, therapy and follow-up (e.g. generate alarms) do qualify as medical devices.
Another example from the commission is a system for managing pre-hospital electrocardiographs (ECGs), which is a software-based system intended for ambulance services to store and transfer information from patients connected to an ECG monitor to a doctor at a remote location.
“Usually the system contains information about patient identification, vital parameters and other documented clinical observations,” the commission says, noting that these systems do not qualify as medical devices. But if there are modules that provide a patient's treatment information to the paramedics in the ambulance to start the patient’s treatment while the patient is being transported, then the software would qualify as a medical device.