A CE Mark Consultant ensures that the specific product complies with EU requirements for sale in the European Economic Area (EEA). Moreover, the consultant also guides companies through regulatory requirements, documentation, testing, and certification processes. It also facilitates market access and legal compliance by ensuring adherence to health, safety, and environmental protection standards.
Conformité Européenne (CE) certification is a regulatory standard most widely used in the European Economic Area (EEA) to verify the safety of products sold in EEA. The standard mandates manufacturers to place a CE Marking logo to demonstrate that a product is CE-certified. The mark exhibits that the product complies with European safety rules and can be traded freely within the EEA. There is no regulatory body to grant a CE mark; however, it is more of a voluntary compliance to expand operations in the EEA. An organisation or manufacturer must conduct an independent conformity assessment by a notified body.
The European Economic Area (EEA) enjoys a prime location in global trade and is the biggest player in the world trading scene. Europe is a competitive market and opens new possibilities for exports to expand their business, especially medium-sized enterprises. Within the European Union, there exists a significant consumer base of approximately 450 million affluent individuals. Moreover, this expansive market spans over 25 countries.
A product can fall under multiple directives, but the CE mark alone doesn’t specify them or the conformity assessment method used to determine it. Additional documents like the Declaration of Conformity provide the information. The CE marking is affixed by the Manufacturer or Authorized Representative, not a Notified Body. An organisation can identify the applicable directives for compliance. The CE Marking has more than 20 directives; these are as follows:
| Directive | Subject (short title of directive) |
| 2006/95/EEC | Low Voltage Equipment (LVD) |
| 87/404/EEC | Simple Pressure Vessels |
| 88/378/EEC | Toys Safety |
| 89/106/EEC | Construction Products |
| 89/336/EEC | Electromagnetic Compatibility (EMC) |
| 89/686/EEC | Personal Protective Equipment (PPE) |
| 90/384/EEC | Non-Automatic Weighing Instruments |
| 90/385/EEC | Medical Devices - Active Implantable |
| 90/396/EEC | Appliances Burning Gaseous Fuels |
| 92/42/EEC | New Hot-Water Boilers fired with Liquid or Gaseous Fuels (Efficiency Requirements) |
| 93/15/EEC | Explosives for Civil Uses |
| 93/15/EEC | Explosives for Civil Uses |
| 93/42/EEC | Medical Devices - General (MDD) |
| 94/9/EC | Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX) |
| 94/62/EC | Packaging and Packaging Waste |
| 95/16/EC | Lifts |
| 97/23/EC | Pressure Equipment (PED) |
| 98/37/EC | Machinery Safety |
| 98/79/EC | Medical Devices - In Vitro Diagnostic (IVD) |
| 99/5/EC | Radio Equipment and Telecommunications Terminal Equipment |
| 00/9/EC | Cableway Installations Designed to Carry Persons |
| 04/22/EC | Measuring Instruments |
A CE Mark Consultant is a professional who provides guidance and assistance to companies seeking to obtain CE marking for their products. The CE mark has over 20 directives covering non-food products; however, an organisation must understand the scope of each directive to determine its applicability. CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
The following are the crucial roles played by the consultancy. These are:
CE Mark Consultants may work independently or as part of consulting firms specialising in regulatory compliance. They play a crucial role in helping companies navigate the complex regulatory landscape and ensure that their products meet the necessary standards for market access in the European Union.
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