wheelchairs
Regulatory marking
Medical devices must have CE marking, UKCA marking or CE UKNI marking by law. This mark means that, provided you use it correctly, the device will work properly and is safe.
No device is 100% safe or reliable., The known risks of complications must be balanced in comparison to the benefits of the device, as stated by the manufacturer.
If you have any questions about weighing up the pros and cons of using a device for personal use, please speak to a healthcare professional.
Buying medical devices for personal use
Before you buy the device
Before you buy a medical device for your own use, it’s important to:
PDF, 962KB, 33 pages).
1. Summary
Part of the MHRA’s role is the regulation of medical devices, including overseeing investigations into adverse events and promoting the safe use of devices in the UK.
The MHRA continues to receive reports of incidents relating to bed rails and associated equipment. These incidents are concerning as some have led to patient harm or death, primarily from entrapment.
This publication has been updated to reflect changes in devices and practices, as well as information gained from the investigation of adverse incidents.
Who this guidance is for:
This document is aimed at all users, carers and staff with responsibility for the provision, prescription, use, maintenance and fitting of bed rails. This includes: