Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device.
A Software is considered a medical devices when it has a medical purpose on its own to be qualified as a medical device software (MDSW). It should be noted that the intended purpose as described by the manufacturer of the software is relevant for the qualification and classification of any device. In order to be qualified as medical device software, the product must first fulfil the definition of software according to this guidance and the definition of a medical device according to Article 2(1) of Regulation (EU) 2017/745 – MDR. To be qualified as an in vitro diagnostic medical device software, the product must additionally fulfil the definition of an in vitro diagnostic medical device according to Article 2(2) of Regulation (EU) 2017/746 – IVDR. Where a given product does not fall under the definition of a medical device, or is excluded by the scope of the Medical Devices Regulations, other Community and/or national legislation may be applicable. Software that does not meet the definition of a medical device or an in vitro diagnostic medical device (i.e. software that is not MDSW) but is intended by the manufacturer to be an accessory for a medical device, or an in vitro diagnostic medical device, falls respectively under the scope of the Regulation (EU) 2017/745 – MDR or Regulation (EU) 2017/746 – IVDR. Software can directly control a (hardware) medical device (e.g. radiotherapy treatment software), can provide immediate decision-triggering information (e.g. blood glucose meter software), or can provide support for healthcare professionals (e.g. ECG interpretation software).
The type of interconnection between the MDSW and the device (e.g. embedded systems, wires, Wi-Fi, Bluetooth) does not affect the qualification of the software as a device under the MDR and IVDR (e.g. whether the software is incorporated in a device or is at a different location). However, MDSW can be placed on the market in two different ways: as a medical device or in-vitro diagnostic medical device in its own right or as an integral component or part of a hardware device.
MDSW placed on the market as a device or put into service in its own right shall undergo an appropriate regulatory process that shall take into consideration the qualification, classification and intended purpose of the MDSW.