The products of a business that decides to trade in the European Union and wants to add CE mark to its products must be in the 23 product groups covered by the New Approach Directives issued by the EU.
Then, the company should prepare a technical document about the products. This document should contain design studies, production processes and operational information regarding the product to be CE marked. In fact, this technical file is the basis of the studies.
If the business wants to add CE mark, regardless of whether the product is in the risk group or the product in the risk-free group, the technical file of the products must be ready.
In the CE marking application, the EU classified the products according to risk groups from A to H as follows:
A: Internal production control
A1: oversee internal production control and product testing
A2: Internal production control and product controls with unexpected visits
B: European Union type examination
A: European Union type compliance in internal production control
C1: overseeing European Union type compliance and product testing in internal production control
C2: European Union type compliance in internal production control and product control with random visits
D: European Union type conformity based on production quality assurance
D1: Production quality assurance
E: European Union type conformity based on product quality assurance
E1: Quality assurance of final product inspection and testing
F: European Union type compliance based on product verification
F1: Compliance based on product verification
G: Compliance based on unit verification
H: Compliance based on full quality assurance
H1: Compliance based on full quality assurance and design review
The manufacturer is responsible for placing the products on the market with CE marking (certificate) and affixing the CE marking to the product. Various alternatives are provided for the manufacturer to attach this mark to the product.
Low risk products
Many products are included in low risk product groups in terms of security. Therefore, by issuing a declaration after the manufacturer has made the conformity assessment; indicates that the product complies with mandatory safety, health, environmental and consumer protection standards. This statement should be drawn up in accordance with the norm.
High risk products
The manufacturer's declaration is not sufficient for these products. In this case, the products must be tested by notified bodies. As a result of the inspection of the notified body, the manufacturer may put the CE mark on his product. The manufacturers of all systems and units produced for use in the final product shall transmit to the manufacturers who will be integrated with a file and declaration of the components and components in accordance with the relevant directive (decree) conditions. Organizations that produce components or components for integration cannot hit the CE mark on their products.
