The CE mark is a specific form of certification or testing. It is not to be confused with third-party certification marks. The CE Mark allows products to be sold within the European Community. It gives national administration members the assurance that all directives are being followed.
Only products that have a CE Mark are legally allowed to be sold in the European Union. For manufacturers who wish to sell their products within the EU, the CE Mark is necessary. Non-EU exporters have discovered that despite their interest in the product, they will not import non-conforming products. You can navigate to this site to get the CE marking certificate to sell your products in the EU.
Simply put, CE marking signifies that the manufacturer has verified that the product meets all requirements of the new approach directives applicable to it. This also signifies that the manufacturer has confirmed that the product has been evaluated according to the prescribed procedures in order to verify that it meets the required requirements.
The CE Marking process involves a thorough examination of manufacturing processes and ensures that the device meets the Union's standards for medical devices and products. A manufacturer can either perform the safety tests on a product manufactured in the EU or hire an independent testing house that has been certified by a competent authority.
The CE mark is then attached by the manufacturer to the product. An approved technical file must be kept that contains documentation proving the manufacturer's reasons for certifying that the product meets EU standards. The product can then be placed on the European Community Market without being challenged by national authorities.