Our colleagues at the MHRA Medicines and Healthcare products Regulatory Agency (MHRA) has today published guidance on human factors and usability engineering for medical devices, including drug-device combination products. It applies to the design of future products and changes in user interfaces of existing products, rather than those already approved for the UK and EU market.
Please use the following link for more details and to access a copy of the guidance.
A short background news story on the development of the guidance can be found here.
If you have any comments or feedback, kindly send these direct to devices.queries@mhra.gov.uk