The Medical Devices Directive 93/42/EEC (MDD) refers to a directive that is created to ensure safety and reliability of medical devices within the European Economic Area. This directive is a ‘New Approach’ Directive and a manufacturer can place a medical device in the European market only after meeting the requirements of the directive. All products that conform to the MDD must possess a CE mark. Recent amendment to the MDD was done by 2007/47/EEC. The MDD is segregated into several classes with different requirements.
Every class is determined by risk. Class I indicates low risk device that is also non-invasive. Subsequent to classification of a medical device, other steps such as creation of Technical File, appointment of European Authorized Representative, issuing Declaration of Conformity and notification of devices are handled by the manufacturer. MDD covers an extensive range of products including first aid bandages, tongue depressors, x-ray equipment, ECG, hip prostheses, spectacles, heart valves and dental materials.