“CE” stands for “Conformité Européene,” which is French for “European Conformity.” The CE marking indicates that a product conforms to specific European directives or regulations, ensuring it meets essential health, safety, and environmental protection requirements. The CE marking is a key indicator of a product’s compliance with EU legislation and allows for the free movement and sale of the product within the European Economic Area (EEA).

Here are some essential aspects of the CE marking:

Scope: The CE marking is used for various product categories, including:

  • Medical devices
  • Electrical and electronic equipment
  • Machinery
  • Toys
  • Personal protective equipment
  • And many others.

Responsibility: The manufacturer is primarily responsible for ensuring product compliance and affixing the CE marking. If the manufacturer is outside the EU, the responsibility can fall on the importer or the EU-based representative.

Process:

  • Risk Assessment: The manufacturer must carry out a risk assessment to determine potential hazards associated with the product.
  • Determine Relevant Directives: The manufacturer identifies which EU directives or regulations apply to their product.
  • Conformity Assessment: Depending on the product and the directive, the manufacturer might need to undergo a conformity assessment process. This could involve third-party testing, inspection, or certification by a notified body.
  • Technical Documentation: The manufacturer must maintain a set of technical documentation or a technical file that provides evidence of compliance.
  • Declaration: Once compliant, the manufacturer or their EU representative must issue a Declaration of Conformity (DoC), declaring that the product meets all requirements.
  • Affix CE Marking: The CE marking is then affixed to the product, its packaging, or accompanying documentation.

Notified Bodies: For certain high-risk products, a third-party assessment by a “Notified Body” is required. These are organizations designated by EU countries to assess product conformity.

Market Surveillance: After a product is placed on the market, it may be subject to market surveillance by national authorities to ensure ongoing compliance.

Misuse: Incorrectly using the CE marking or using it without proper compliance can lead to penalties, product recalls, or bans from selling in the EU.

Brexit: Following Brexit, the UK introduced the UKCA (UK Conformity Assessed) marking, which is the UK’s version of the CE marking. Products intended for the UK market (excluding Northern Ireland) will eventually need to carry the UKCA marking instead of the CE marking.

In summary, the CE marking is a declaration by the manufacturer that their product complies with the applicable EU requirements. It’s an essential aspect for manufacturers and traders aiming to sell products within the EEA.