Medicines and Healthcare products Regulatory Agency
This guidance, , is intended to be a useful resource on human factors and usability engineering principles, to clarify the expectations of the regulatory bodies i.e. notified bodies and competent authorities, around compliance with the current and future EU medical device legislation.
It is aimed at manufacturers of all device classes who intend to market their device in the UK. The principles are also relevant to device components of drug-device combination products that are regulated as medicines.
It may also be useful to commissioners of medical devices within the healthcare system and NICE, in order to investigate and challenge whether appropriate attention has been given to design features of a medical device to ensure safe and effective use in the intended environment.
We welcome your comments via which can be emailed to dts@mhra.gsi.gov.uk
Deadline for comments: 5 August 2016