IEC 82304 – What the standard requires of “health software”
IEC 82304 is now available. This is a good reason to take a closer look at this standard for “health software products.”
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.
Further information
Read more about legally compliant software development and IEC 62304 here.
3. Support for medical device manufacturers
Benefit from the support of the Johner Institute:
- Do you have questions about developing and approving medical devices that contain or are software? Our free micro-consulting will provide you with answers.
- In the medical software compact seminar, you will acquire the prescribed competencies. You will learn about and fulfill the legal requirements for software development.
- The Medical Device University’s video training will help you to create a lean and IEC 62304-compliant “software file” step by step. In addition, a complete set of templates takes a lot of work off your hands.
- You can also benefit from the support of our experts. They will help you to document your software briefly, precisely, and in compliance with the laws and standards and prepare you for audits and tech file reviews.
- Have the IT security of your software evaluated using penetration tests.
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.
Risk management and risk analysis for software
Software risk analysis depends on the following: Software itself cannot cause harm. It always happens via hardware or people. However, this does not mean there is no need for risk analysis in software. The opposite is the case!
PESS: Programmable Electronic Subsystems
IEC 60601-1 defines a PESS, a Programmable Electronic Subsystem, as a system based on one or more central processing units, including their software and interfaces. The standard does not reveal what it means by system; in this context, it is a medical device component. For this, IEC 60601-1 sets out specific requirements for the PESS.
Details