EU Medical Device Directive5 December 2012
EU Medical Device Directive (93/42/EEC)
The Medical Device Directive applies to any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception
Before you can market your medical device in the EU, your product must meet the essential requirements in Annex 1 of the Medical Devices Directive, as well as the standards related to your device class (1, IIa, IIb or III)).
The Medical Device Directive 93/42/EEC is a directive designed to ensure that medical devices are safe and reliable within the European Economic Area. Compliance with the new regulations has been mandatory since March 21st 2010.
The Medical Device Directive is divided into different device classes with varying requirements. These classes are determined by risk. Following the procedures outlined in the Medical Device Directive Annex IX will help manufacturers to determine the class of their devices.
Class 1, Class II and Class III
Class I devices with low risk such as external patient support products
Class IIa/b devices with medium risk such as electro-medical devices
Class III devices with high risk such as cardiovascular catheters