Software as a medical device

Any software is by definition a medical device when it is used alone or in combination with other medical devices to obtain information for detecting, diagnosing, monitoring, predicting or treating physiological conditions, state of health, illnesses or congenital deformities. The requirements also apply to standalone software that drives or influences the operation of medical devices.

Defining software as a medical device or in vitro diagnostic (IVD) device almost invariably requires case-by-case assessment. Conducting this assessment is the responsibility of the software manufacturer. Guidance on the definition and classification can be found from the EU MDCG 2019-11 guideline as well as from the guidelines on software issued by certain medical device regulatory authorities. Guidance on the classification of IVD devices according to the Regulation can be found in MDCG 2020-16. As a rule, any software that drives a device or influences the use of a device shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right. The risk classification of medical software is guided especially by classification rule 11 of the Regulation (2017/745, Annex VIII). With regard to software that is considered as an IVD device, the classification shall follow the corresponding principles of the IVD Directive (98/79/EC) or the classification rules of Annex VIII to the IVD Regulation (2017/746). 

Software and applications designed for mobile devices can also be medical devices, as well as, in certain cases, laboratory or patient information systems or parts thereof.

Software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation. The IEC 62304 standard describes the life cycle management processes of medical software and is applicable to devices where the software is part of a medical device as well as to software that is independent of any other device.

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MDCG 2019-11 (European commission)

Is your software a Medical Device? (European commission)

MDCG 2020-16 (European commission)