Medical Devices Directive
A medical device is defined as “all kinds of equipment, apparatus, devices and other materials used alone or together with other devices on human beings to diagnose, prevent, monitor, treat or compensate for the illness, examine or change the anatomy of human beings or physiological process, control pregnancy and which do not fulfil its actual purpose on human body through pharmacological, immunological or metabolical means but which receives help from these means including the equipment necessary for the intended use set by the producer.
Directive published relating to the production of medical devices determines the products assessed under the directive, responsibilities of the producers and the requirements to be met by the products before they are introduced to the market.
- Define the requirements to be met before the medical devices are introduced to the market
- Establish compliance assessment procedures according to device classifications
- Report present mechanisms to national authorities to monitor and protect public health
If you want to introduce a medical device within the member states of the European Union, the product must comply with the basic requirements of the Medical Devices Directive. MDD 93/42/EEC + 2007/47/EC. Harmonized standards (e.g. EN EMC 60601-1-2:2001 and for electricity safety EN 60601-1 etc.)
