What is this standard about?
It deals with medical device software. The amendment adds requirements for legacy software which will help manufacturers demonstrate compliance with the relevant European Directives.
Who is this standard for?
The standard is relevant to manufacturers of:
- Medical electrical equipment
- Medical devices incorporating software
- Software that is itself a medical device
Why should you use this standard?
The amended standard applies to the development and maintenance of medical device software when the software is itself a medical device or when software is embedded or an integral part of the final medical device.
What’s changed since the last update?
Amendment 1 adds requirements to deal with legacy software, where the software design is prior to the existence of the current version. It will help manufacturers show compliance with the standard in order to meet European Directives. Software safety classification changes needed for this amendment include clarification of requirements and updating of the software safety classification to include a risk-based approach.
