CE-Mark Conformity with European Union New Approach Directives

The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives.

The CE mark is not a quality-mark. First, it refers to the safety rather than to the quality of a product. Second, most quality markings are voluntary opposite to the CE marking, which is mandatory for the products it applies to. CE indicates conformity with mandatory European safety requirements. European conformity is certified by following clear and understandable procedures, the so-called ‘conformity assessment procedures’.

The CE mark is applicable to: medical devices, machinery, industrial installations, toys, electrical equipment, electronics, domestic appliances, pressure equipment, personal protective equipment, recreational craft, refrigerators etc. The CE marking does not apply to: cosmetics, chemicals, pharmaceuticals, foodstuffs.

The “New Approach” identifies level of risk and hazard. Annexes to the various EU directives will specify levels of risk and types of products that would need to be either certified by a notified body or if the product can be certified by the manufacturer as conforming to the particular directive(s). The EU’s laws and regulations made it compulsory to comply with the directives when goods are sold in the territory of the European Union and the European Economic Area (EEA). Companies must show evidence of product compliance by maintaining or presenting a technical file that includes product specifications, technical drawings and standards applied per the appropriate directives and corresponding annexes.

On April 2004, The Government of Turkey’s Undersecretariat for Foreign Trade announced the implementation of twenty-three European Union industrial directives, which would affect an estimated 70% of the manufactured products imported into Turkey. With this, CE Mark becomes mandatory for domestic market products and imported products.