Medical software includes all software used for healthcare, particularly for medical devices or medical devices (embedded software), and software that is itself a medical device (standalone software).
IEC/CD1 82304-1 (Health Software – Part 1: General requirements for product safety) distinguishes between the following terms:
This clarifies that medical software can be a medical device but does not have to be.
Fig. 1: Medical software includes medical device software and software as a medical device (click to enlarge).
The question often arises as to when medical software meets the definition of a medical device. You can find a further discussion on this topic in the article on the classification of software as a medical device and in the article on the qualification and classification of IVD medical device software.
Software that is a medical device or part of a medical device must meet the regulatory requirements:
Read more about legally compliant software development and IEC 62304 here.
Benefit from the support of the Johner Institute:
Contact us right away so that we can discuss the next steps. This will ensure that the “approval” is a success and that your software or devices are quickly launched on the market.
MDCG published guideline MDCG 2023-4 in October 2023 entitled “Medical Device Software (MDSW) – Hardware combinations – Guidance on MDSW intended to work in combination with hardware or hardware components.”
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