A CE marking is a self-certification required for applicable products entering/being placed on the market in the EU. The CE certification mark signifies that the product meets applicable directive requirements. All EU countries require CE certification, and some countries that are not official EU members also require CE certification.
The CE mark signifies the manufacturer’s declaration that a product meets the requirements of the applicable EC directives (formerly referred to as “New Approach Directives”). The first step in the process is to identify whether or not the product is required to bear the CE mark. Not all products are required to bear the CE marking, only the products that fall within the scope of at least one of the EC directives require it. There are more than 20 EC directives.
Identifying which directive(s) are applicable to a product requires someone (preferably with a technical background) to review the scope of each directive, and establish which apply to the product in question. If the product does not fall within the scope of any of the directives, the product is not required to bear the CE mark, and in fact is precluded from bearing the CE marking.
Demonstrating compliance to the Medical or Machinery Directives have long relied on risk management to ascertain risks posed by these types of products. G&M’s team has been there assisting customers in these areas from the start. Our team is experienced in the different methods of hazard analysis and how to best apply them.
As a consulting laboratory, G&M’s team is required to have a solid grasp of regulatory requirements along with the ability to align certification programs to our customer’s needs. Whether it’s testing one sample to represent a family, identifying requirements that are not applicable under specific conditions, or providing preliminary evaluations, we have the background to properly manage your CE Certification Project. A Certification Body route on the other hand, can be derived from a platform of bureaucracy, resulting in delays and frustration from overly restrictive practices.