CE is an abbreviation for Conformité Européenne, which refers to the safety requirements of items marketed or manufactured within the European Economic Community. It has been in force as a widely recognized standard since 1985 and certifies that a piece of equipment meets the highest safety standards of the applicable EU legislation to which the product is subject. As an employer, CE marking is a great and simple approach to ensure that the equipment that uses is safe and suitable for the purpose.
List of documentation for CE marking compliance
Organizations must establish that their product complies with the directions if an enforcement agency questions its compliance. To give CE marking documents of product conformity, perform the necessary CE mark certification or testing, and save backup documents in the files. Keep in mind that each product may contain additional components that must adhere to different standards and laws. Create a specific technical file including the following information for products that require CE mark certification:
- General description of the product
- Information about how to operate the product
- Design and manufacturing diagrams, including structures of parts and subassemblies
- A list of the applicable synchronized standards such as those specified by the British
- Standards Institution in the UK
- An explanation of the methods used to meet the essential requirements for each product
- Directives that apply to the product
- The result of any design calculations
- Test reports from the supplier or those you commissioned by an independent testing body
List of products that require CE marking
Even though all of the directives and regulations are in place, producers do not have a comprehensive product list or nomenclature on which to rely to determine whether CE marking directive(s) apply. However, the CE certification only applies to products placed in service or for sale in the EEA market.
To determine whether a product requires CE certification, management must first select which countries their products will be sold in and which directives (if any) apply to the products. The classifications listed below can assist you in determining where your product fits:
Construction Products – This category contains products designed for permanent inclusion in construction projects such as buildings and infrastructure (civil engineering). CE markings for construction materials are not required for goods sold in the United Kingdom, Sweden, Portugal, or Ireland, however many other EU member states may.
Electromagnetic Compatibility – These types of products include virtually all electrical and electronic appliances, equipment, and apparatuses that might cause or are impacted by electromagnetic disturbance.
Gas Appliances – Appliances that use gas or other fuels for heating, cooking, hot water generation, lighting, refrigeration, or washing must also have CE marks. This regulation does not apply to appliances whose water temperature does not exceed 105°C or to industrial equipment.
Low Voltage – Electrical equipment with a voltage rating of 50 to 1000 AC (alternating current) or 75 to 1500 VDC (direct current) must be CE marked.
Machinery – This category refers to machines or equipment with mechanically linked components or parts. A minimum of one component must be moved by a mix of actuators, controllers, and power circuits that work together for a specific application. This class also includes the assembling of machines and interchangeable equipment that alters the function of a machine. Furthermore, this category comprises machinery safety components and has exclusions that makers and importers must address.
Medical Device – The medical device category includes single-use items as well as non-automated weighing equipment. In-vitro diagnostic or active implanted medical devices are not included.
Instruments – This category comprises shop scales, balances, platform machines, and weighbridges, which determine taxes, bonuses, tolls, and tariffs and require the help of an operator while weighing. It also includes instruments used in police enforcement, health monitoring, and pharmacy medicine production.
Personal Protective Equipment – This category contains personal wearable appliances or devices that defend against a safety or health threat. Cricket pads to safety helmets are among the items available.
Pressure Equipment – The pressure equipment and assembly’s directive apply to apparatus with an internal pressure greater than 0.5 bar. Vessels, heat exchangers, pressurized storage containers, industrial pipework and accessories, and shell and water tube boilers are all included in this category.
Recreational Craft – This covers boats meant for leisure and sports, independent of the propulsion system. It also contains boats with hull lengths ranging from 2.5 to 24 meters, as well as half-finished recreation watercraft and components.
Simple Pressure Vessels – This applies to vessels made of welded aluminum or metal that are designed to hold nitrogen or air under a pressure of 30 bars or less. Reservoirs for compressor units, as well as automotive and rail braking systems, fall under this category.
Toys – Most toys that are designed for play by children under the age of 14 will fall into this category.
As previously stated, any products that the organization wishes to sell will require CE marking. The CE Mark consultant can help organizations get CE certification quickly and successfully by providing CE marking certification consultancy.
