Trusted Consulting Services to Meet CE Mark Compliance Requirements
CE Marking Compliance
In addition to designing machinery and equipment to be as safe as possible for end users, today’s manufacturers must also ensure regulatory compliance. Regulatory markings are required on products being shipped into and out of certain countries to comply with various national and international product labeling regulations. Failure to label a product with required markings could result in it being permanently shelved in addition to costly fines and penalties. Within European Union (EU) member states, or for trading in the European Economic Area (EEA) and European Free Trade Association (EFTA) countries, most products are mandated to have a Conformité Européenne (CE) mark present.
Why the CE Mark is Needed
The letters “CE” appear on products produced and distributed in Europe. The CE marking, a requirement based on EU directives for products, is a declaration by the manufacturer that its product complies with the relevant, legal European requirements. It signifies that the product has been assessed to meet high safety requirements – which has benefits for both businesses and consumers. By showing the CE mark, businesses know that the product can be traded in the EU, EEA and EFTA, and consumers are guaranteed a level of safety throughout those areas. Because only one mark is required to show CE compliance in over 30 countries, it simplifies factors for machine builders and distributors.
CE Marking Requirements for Manufacturers
Manufacturers are responsible for verifying that their products meet EU requirements for safety, health and the environment. They must carry out the conformity assessment, maintain technical files, complete an EU Declaration of Conformity and affix the CE mark to their product. The procedure varies by product but generally includes these six steps:
- Identifying applicable directive(s) and harmonized standards
- Verifying product-specific requirements
- Identifying whether an independent conformity assessment by a notified body is necessary
- Testing the product to check its conformity
- Compiling and keeping available required technical documentation
- Affixing the CE marking and completing an EU Declaration of Conformity, which must include:
- The manufacturer's name, trademark and contact information
- A list of the directives and standards used in the assessment of the product, and
- Information on any notified body involved in the product's conformity assessment.
Our CE Mark Consulting Services
Navigating the CE marking process doesn’t have to be painstaking. We offer comprehensive machine safety and risk consulting services through Clarion Safety Assessment. That includes CE marking services to help you ensure that you’re meeting necessary requirements and are in compliance.
As part of our CE marking consulting services, we can help you:
- Determine which directives apply to your product
- Meet applicable requirements
- Create and maintain relevant technical documentation (which must be retained for at least 10 years after your product’s last date of manufacture)
- Affix your product with a CE mark label
- Complete your EU Declaration of Conformity