SOFTWARE: Qualification and classification

On the 11th of October 2019, the MDCG issued a Guidance on the qualification and classification of software under the MDR and IVDR.

The MDCG first defines “software” as a set of instructions that processes input data and creates output data. Non-exhaustive list of both types of data is provided in the Guidance.

The MDCG differentiates software from a Medical device software (MDSW), which 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.

Software must have a medical purpose on its own to be qualified as a MDSW. Identical to the qualification and classification of other medical devices, it is relevant how the manufacturer describes the intended purpose of a software.

The MDCG proposes the below decision steps for qualification of software as MDSW:

    1. Is product a software in accordance with the definition of this Guidance?
    2. Is product a device under Annex XVI, accessory for a MD or is software driving or influencing the use of a MD? If yes, it follows the regulatory process of that device/accessory.
    3. Does software perform an action on data, or performs an action beyond storage, archival, communication, simple search, lossless compression?
    4. Is the action for the benefit of individual patients?
    5. Is software in accordance with the MDSW definition of this Guidance (See underlined above)?

Secondly, the MDCG proposes the decisions step for qualification of MDSW as either a medical device or an in vitro diagnostic medical device (MD MDSW or IVD MDSW):

    1. Does MDSW provide information within the scope of the (in vitro diagnostic) medical device definition?
    2. Does the MDSW create information based on data obtained by IVDS only? If no, step 3.
    3. Is the intended purpose substantially driven by data sources coming from (in vitro diagnostic) medical devices?

Practical examples can be found in Annex II of the Guidance.

When it comes to the classification of MSDW as per the MDR, the MDCG indicates Implementing Rule 3.3 and 3.5, Rule 11 and its sub-rules of Annex VIII MDR, as well as applicable Rule 13, 15 and 22. Annex III of the Guidance contains a table on the Usability of the IMDRF risk classification framework in the context of the MDR.

Regarding MDSW as per the IVDR, Implementing Rule 1.4. and 1.9 of Annex VIII IVDR are invoked. Examples of classification are provided in Annex IV to this Guidance.

Finally, Annex I needs to be mentioned as it offers range of illustrative examples of software used in healthcare environment, such as software module generating alarms based on the monitoring and analysis of patient specific physiological parameters is qualified as a medical device (MDSW).

The MDCG also observes – in view of the technological process – both this Guidance as well as the Manual on borderline products will be continuously updated. Follow our News section not to miss any new entries that will help you to classify your product correctly.

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