From bandages to breast implants, all medical devices are classified according to the risks they potentially pose to patients (as well as the level of regulation involved in their manufacturing, marketing and usage).
Under EU law, medical devices are sorted into the following categories:
- Class I
- Class IIa
- Class IIb
- Class III
About Class I Medical Devices
Class I medical devices are low-risk products that are subject to relatively little regulation. Examples of Class I medical devices include stethoscopes, bandages, and surgical masks.
The defining characteristic of any Class I medical device is that is poses little or no risk to patients. The greater the risk posed, the more regulation is required, the higher the medical device's classification.
In the UK, medical devices are subject to the Medical Devices Regulations 2002.
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