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 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 it 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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This guidance and label template will help companies whose products require the UKCA mark by providing an editable template which includes all the mandatory traceability information requirements
An overview of the requirements of this UK legislation together with a ‘Declaration of Conformity’ Template which can be edited and rebranded as required
This guidance and label template will help companies whose products require the UKCA mark by providing an editable template which includes all the mandatory traceability information requirements