Medical Devices Directive (MDD)
The current Medical Devices Directive 93/42/EEC (MDD) was taken effect in 1993, and has been revised in 2010.
The MDD concerns medical devices that are manufactured or traded in the EU. The MDD applies to all general medical devices that do not fall under the EU regulations Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDMD). If devices meet all MDD requirements, they will be CE-marked.
Replaced by MDR
The Medical Devices Regulation (MDR) published in May 2017 will replace the MDD. The full application of the MDR takes effect in 2021. Read more about the MDR
Kiwa Notified Body for medical devices
Kiwa is a Notified Body on medical devices certification services according to the MDD and subsequent amendments. Read more
Medical devices definition
The MDD applies to all general medical devices that do not fall under the the Active Implantable Medical Devices Directive (AIMDD) or the In Vitro Diagnostic Medical Devices Directive (IVDMD).
There are hundreds of thousands of medical devices on the EU market such as, for example contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters.
The term medical device means whatever tool, device, installation, material or other product, used individually or in combination, including also the software applied for the correct employment, designed by the manufacturer in order to be used on human beings with the purpose of:
- diagnosis, prevention, control, therapy or attenuation of a disease;
- diagnosis, control, therapy, attenuation or neutralization of an injury or a handicap;
- studying, substituting or modifying the anatomy or a physiological process;
- intervening on the conception, in those circumstances where the product does not exercise the main action through pharmacological or immunological means, nor through metabolic processes, but where the used mean assists the function for which it is employed, inside or on the human body for which it is intended.