Implementing the UK Medical Device Regulations

This SOP provides guidance on:

• How to seek advice and support from the RDS team and InnoScot Health when you are using the Right Decisions Platform to deliver a decision support tool that meets, or potentially meets, the criteria for software as a medical device.
• When decision support systems (DSS) are categorised as a medical device.
• Classification of medical devices and anticipated changes in medical device legislation.
• The role of InnoScot Health as manufacturer for UK CA marking of right Decision Service tools categorised as medical devices.
• A summary of the technical documentation required to register a decision support tool as a medical device and obtain UK CA marking.

This is high level guidance and should not be used as a substitute for reading the legislation and full guidance from the MHRA and other bodies referenced in this SOP.

This guidance is not to be used in isolation. You cannot on your own acquire UK CA marking for a decision support tool built using the Right Decisions Platform.  InnoScot Health is the manufacturer which holds liability for all RDS tools categorised as medical devices. It is essential that you engage with the RDS team at an early stage in order to engage with InnoScot Health and:

• Determine whether your RDS decision support tool meets the criteria for a medical device.
• Determine the risk classification, if your decision support tool is categorised as a medical device.
• Work with InnoScot Health, the RDS team and Tactuum, the software company which develops and maintains the RDP, to produce documentation and follow processes to the required standards.

Decisions about medical device justification and classification need to be made on a case-by-case basis, and there are often different arguments and interpretations to be considered.