To be placed on the European market, medical devices first have to be submitted to the CE marking process.
This CE marking means that the device complies with the requirements of all applicable Directives.
The main requirements for safety and performance that are applicable to the medical devices (MD) are defined in the 93/42/EEC Directive (amended in 2007).
However, Medical Devices also have to comply with another Directives:
The Directive 93/42/ECC defines 4 classes for the Medical Devices (I, IIa, IIb and III), according to the risk related to the technological characteristics of the devices and to the way they will be assessed. The higher the class of the device is, the more strengthened the rules of evaluation and of control will be.
In all cases, the company in charge of placing the MD on the market must both:
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