A new draft of IEC 62304 has been created

A draft of Edition 2 of IEC 62304 has been produced. IEC 62304 Medical device software — Software life cycle processes establishes life cycle requirements for development of medical device software.

Although it is not expected to be adopted until at least 2028 the standard is expected to expand its scope from “medical device software” to “health software”. The term “health software” would include software that does not fall within the current definition of medical device software of “software system that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a medical device”. Although the text has not yet been published some additional requirements that will be introduced in Edition 2 have been identified. These include the introduction of security risk management as part of risk management and a requirement that manufacturers manage risks arising from a lack of fitness for purpose.

The current classification of device risk within Safety classes A, B, and C are expected to be replaced by Level I, and Level II. The process rigour within Level II will be more demanding that that in Level I. Some types of software are expected to be upclassed. Software falling within Safety class B, which includes software systems that can lead to a hazardous situation even after risk control measures have been taken, but the possible resulting harm is not severe is expected to be moved to Levell II, meaning that it may be required to fulfil the same level of requirements as that imposed on devices falling within Class C which are devices that present a potential risk of death or serious injury.