CE Legislation
European Directive 93/42/EC
Worldwide there are different laws and regulations concerning medical devices. Medical devices sold in the European Community must have a CE mark. Every medical device brought onto the market needs to fulfil the requirements of the European Directive 93/42/EC and needs to be registered with the Ministry of Health. Each medical device or group of medical devices must have a CE-Declaration of Conformity. The medical devices that Orfit Industries manufactures are class 1 low risk, non-invasive products. They are in compliance with the European Directive 93/42/EC. Since it manufactures class 1 medical devices, Orfit Industries is allowed to self-certificate. It is allowed to draw up his CE-Declaration of Conformity for each medical device that it brings onto the European market.
On 21 March 2010 the European Parliament approved a new European Directive 2007/47/EC for these types of medical devices, The Parliament of Belgium approved this new amendment to adapt the existing law. As such, the new European Directive 2007/47/EC is effective in Belgium.
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