European Commission Issues Guidance On Standalone Software As Medical Device Or IVD

The European Commission is offering guidance to define the criteria for the qualification and classification of standalone software used in a healthcare setting as a medical device or in vitro diagnostic (IVD).

The Commission includes pertinent definitions in the first section of the guidance document MEDDEV 2.1/6, which defines “stand alone software” as software that is not incorporated in a medical device at the time of its placing on the market or its being made available. “Software as a Medical Device” (SaMD) is defined as software intended for use for one or more medical purposes, and that performs these purposes without being part of a hardware medical device. Standalone software shall be qualified as an in vitro diagnostic (IVD) medical device or as an accessory to an IVD provided it satisfies the definition of an IVD, or that of an accessory to an IVD, as set out in Directive 98/79/EC, according to the guidance.

Per the Commission, in order to qualify as a medical device, standalone software should be able to 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, notes RAPS.

Specific to IVDs, the Commission states, "Provided that stand alone 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 stand alone falls under the scope of the IVD Directive and shall be treated as an IVD device in its own right."

The Commission provides separate decision trees/diagrams of steps to qualify standalone software either as medical device or IVD. It also provides illustrative examples showing whether or not common (but not all) software serving a medical purpose is considered as a medical device.

For instance, hospital information systems (e.g., systems for patient admission, scheduling patient appointments, or insurance and billing purposes) are not qualified as medical devices.

Decision support software, which includes computer-based tools to assist clinicians in their diagnosis, prognosis, monitoring, and treatment of patients, can be considered as a medical device. Using these criteria, radiotherapy treatment planning systems, drug (e.g., chemotherapy) planning systems, and computer-aided detection systems are all qualified, according to the Commission.

Not qualified as medical devices in themselves, though, are information systems intended only to store, archive, and transfer data, such as electronic patient record systems, clinical information systems/patient data management systems (PDMS), pre-hospital electrocardiograph (ECG) systems, and picture archive communication systems (PACS). However, if such systems include additional modules, they might qualify as medical devices. For example, an intensive care unit's information-storing PDMS could qualify as a medical device if it includes a module that impacts patient treatment (e.g., it generates alarms). These software-generated alarms also could qualify other communication systems as medical devices.

The Commission considers telesurgery systems and remote-control software, used in combination with telesurgery robots, as medical devices. However, video appointment software used in remote consultations is not qualified.

Home care monitoring, and wired or mobile communications software are not considered medical devices, according to the Commission. However, web systems consisting of modules that remotely monitor implants, such as pacemakers or implantable cardiac defibrillators (ICDs), are considered as such.

Regarding IVD software, Laboratory Information Systems (LIS) and Work Area Managers (WAM) in general are not qualified as medical devices, but extra modules could prove them otherwise.

In discerning whether standalone software is treated as a medical device or an in vitro diagnostic (IVD) device, the Commission will pay particular attention to how the manufacturer presents data in product labels, instructions, and/or promotional materials.

“Stand alone software must have a medical purpose to be qualified as medical device. It should be noted that only the intended purpose as described by the manufacturer of the product is relevant for the qualification and classification of any device and not by virtue of the way it may be called,” states the Commission.