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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, MD also have to comply with another Directives :
The Directive 93/42/ECC defines 4 classes for the MD (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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Being accredited for a set of electromedical standards, LCIE Bureau Veritas offers their expertise to manufacturers, retailers and importers of electromedical devices. LCIE Bureau Veritas is an active member of standardization commissions (UTE).
Through the Bureau Veritas worldwide network of laboratories we offer you an international set of services.