Ce mark
CE mark The CE mark (Conformité Européenne) is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE mark is also found on products sold outside the EEA that have been manufactured to EEA standards. This makes the CE mark recognizable worldwide even to people who are not familiar with the EEA.
History[edit | edit source]
The CE mark was introduced in 1985 as part of the European Union's (EU) efforts to harmonize product standards across member states. The mark signifies that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EEA.
Purpose[edit | edit source]
The primary purpose of the CE mark is to facilitate trade within the EEA by ensuring that products meet common standards. This helps to remove barriers to trade and ensures that consumers have access to safe and reliable products. The CE mark is not a quality indicator but rather a declaration by the manufacturer that the product complies with the relevant EU legislation.
Products Requiring CE Marking[edit | edit source]
A wide range of products require CE marking, including but not limited to:
- Medical devices
- Toys
- Machinery
- Electrical equipment
- Personal protective equipment
- Construction products
Process of CE Marking[edit | edit source]
The process of obtaining a CE mark involves several steps: 1. Identify the applicable EU directives and regulations. 2. Ensure the product complies with all relevant requirements. 3. Determine whether an independent conformity assessment (by a Notified Body) is necessary. 4. Test the product and compile a Technical File. 5. Affix the CE mark and draft an EU Declaration of Conformity.
Enforcement[edit | edit source]
National authorities in each EEA country are responsible for enforcing CE marking requirements. They have the power to take action against manufacturers who fail to comply, including fines and product recalls.
Related Pages[edit | edit source]
- European Economic Area
- European Union
- Medical devices
- Notified Body
- Technical File
- EU Declaration of Conformity
See Also[edit | edit source]
References[edit | edit source]
External Links[edit | edit source]
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Contributors: Prab R. Tumpati, MD