CE marking of medical devices
Medical Devices (MD) are a very diverse set of products, ranging from consumables to large equipment:
syringe, stethoscope, catheter, MRI (Magnetic Resonance Imaging), Use both to diagnose a disease (diagnosis), to prevent its appearance (prevention), or to treat its effects (therapeutic care), medical devices occupy a more and more place more important in the health sector.
To circulate freely in the European Economic Area (EEA), medical devices must necessarily bear the CE marking. This is the case of medical products.
The CE marking (European Community marking) on a medical device (DM) means that this DM complies with the legal requirements of the European Union directives on health and safety. The company must demonstrate that its product meets the quality and safety requirements. It then benefits from the affixing of CE marking.
Once it has been affixed, it allows the medical market to be marketed in all member states of the European Union and the European Economic Area.
It constitutes a mutual recognition of harmonized legislation between the Member States.
CE marking is mandatory for all marketing:
* since January 1, 1995, on Active Implantable Medical Devices (IMAD)
* since June 14, 1998 on other DM.
The CE marking of our medical products brings you many benefits as users of our products:
* The CE marking on one of our products is a sign for governments that the product complies with the quality and safety requirements and can be sold legally in the European Union, as well as in the European Free Trade Area. .
* It allows the free movement of products within the single European market.
* It is the guarantee for our customers of a product that complies with safety standards and guarantees quality.
* It reinforces our credibility of product, which contributes to the satisfaction of our customers.
CE marking of medical devices
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