1. Definitions
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:
- HEALTH SOFTWARE
Software intended to be used specifically for maintaining or improving health of individual persons, or the delivery of care
- MEDICAL SOFTWARE
Software intended to be used specifically for incorporation into a physical medical device or intended to be a SOFTWARE MEDICAL DEVICE
- SOFTWARE MEDICAL DEVICE
Software intended to be a medical device in its own right
- MEDICAL DEVICE SOFTWARE
Software intended to be used specifically for incorporation into a physical medical device
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).
2. Regulatory requirements
a) Medical software – a medical device?
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.
b) Regulations, laws, standards
Software that is a medical device or part of a medical device must meet the regulatory requirements:
- In Europe, the medical device regulations (MDR, IVDR) are relevant. However, these only contain relatively general regulations for software, which this article presents.
- IEC 62304 defines the life cycle processes for medical device software.
- IEC 82304-1 applies to all “health software”. IEC 82304-1 also requires conformity with the requirements of IEC 62304.
- There are also MDCG guidelines, e.g., MDCG 2019-11 and MDCG 2023-4.
- The FDA sets out specific requirements in its guidance documents, including specific requirements for medical software. It also answered many questions specifically about software as a medical device in this FAQ.
3. Support for medical device manufacturers
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.
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