It is a legal requirement. CE Mark is the manufacturer's claim that the Medical Device / Medical Product / Medical Equipment /
Medical Device Component meet the essential requirements of relevant European Directives.
There are three European CE marking directives that specifically apply to medical devices manufacturers:
MDD 93/42/EEC + 2007/47/EC - The Medical Devices Directive applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
Principles of the CE marking:
- The CE mark shall be affixed only by the manufacturer or his authorized representative.
- The CE mark shall be affixed only to products which requires it as per European Community law, and shall not be affixed to any other product not included.
- Indicate a product's conformity with the "essential requirements" of the directives.
- By CE marking the manufacturer declares that he takes responsibility for the conformity of the product with respect to the Directive.
- Any other marking may be affixed to the product provided thus the visibility, legibility and meaning of the CE Mark are not thereby misrepresented
- Member States shall ensure the correct implementation and take appropriate action in the event of improper use of the marking.
- CE Marking for gaining access to the EFTA & European Union market. Ensure the "free movement of goods.
