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Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products

MHRA has produced draft guidance for medical devices including drug-device combination products and we welcome your comments

This guidance, Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products (PDF, 543KB, 30 pages) , 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 Comment sheet (MS Word Document, 215KB) which can be emailed to dts@mhra.gsi.gov.uk

Deadline for comments: 5 August 2016