21st May, 2018
by Bruce Lovell
Next review: 21st May, 2019
The Medical Devices Directive (MDD) 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 directives look at eliminating or reducing risk of injury the MDD takes a different view, balancing risk against benefit. Effectively the MDD accepts that some products might pose a health risk to the user, but it is outweighed by the benefits.