Class 1 medical device

What Is A Class 1 Medical Device?

A Class 1 medical device is a product that has been registered with the Medical & Healthcare products Regulation Agency (MHRA). This means it has been designed and thoroughly tested, with evidence based research to prove it is safe and effective to use.

Under the Consumer Protection Act 1987, regulations exist to ensure medical devices meet the requirements so that they are acceptably safe to use and suitable for their intended purpose. Any manufacturer of a medical device must follow these guidelines alongside the relevant Part of the UK MDR 2002.

How do I know if my support is a Class 1 medical device?

All Ultimate Performance supports and braces are registered as Class 1 medical devices so you know you are buying a safe and effective product.

If something is worn on the body to help with an injury, it’s a medical device. To show it’s registered as such like any medicine or medical device, with the MHRA, it should state “UKCA” and “Class I” medical device on the packaging.

If you buy a support or brace that is a lot cheaper, but does not show the compliant marks, you might wonder how thoroughly the manufacturer has designed and tested it’s products. It certainly is not complying with the legal requirements set out for the industry.

Medical Device Classification

The classification of a particular product is based on the level of risk they pose to patients and users.

Class 1 Medical Devices

Class 1 devices are low-risk devices. Examples of Class 1 medical devices include supports & braces, bandages, handheld surgical instruments, examination gloves, and many non-invasive diagnostic devices like thermometers.

These devices are considered to have the lowest potential risk and are generally simple in design and function. They are typically not intended to sustain or support life and have a low potential for causing harm to the user.

Class 2 Medical Devices

Class II devices are intermediate-risk devices. Examples include CT scanners or infusion pumps for intravenous medications.

Class 3 Medical Devices

Class 3 devices are high-risk devices that are very important to health or sustaining life. Examples include pacemakers and deep-brain stimulators.