The Medical Devices Regulations (MDR) has an extremely broad remit and covers all products/equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. It is important to understand that the intended purpose and the way a product is marketed can cause them to be covered or excluded from this directive.
Where other regulations look at eliminating or reducing the risk of injury the MDR takes a different view, balancing risk against benefit. Effectively the MDR accepts that some products might pose a health risk to the user, but it is outweighed by the benefits.
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