Regulatory Update - Human Factors Usability Engineering Guidance

Following the end of the transition period with the EU, the MHRA has just updated the Human Factors and Usability Engineering guidance (first published September 2017) document to reflect changes to the regulation of medical devices in the UK.

 

 

This guidance is specific to medical devices placed on the market in Great Britain (England, Wales and Scotland). For Northern Ireland, different rules apply to those in Great Britain.

It is intended for all classes of devices including drug-device combination products.

Download the full MHRA document here

For all your medical device needs, Mi3 are the experts in designing, developing and manufacturing end-to-end advanced medical and surgical solutions – providing specialist knowledge in injection moulding, device assembly & packaging, thermoplastic engineering, tubing systems, and regulatory compliance whether these be under the new UK rules or for a global product launch, our team of device engineers and regulatory experts can advise and support you in your device journey. Contact us today.