What Is CE Marking?
Conformite Europeenne - Certification for European Union
The CE marking is a mandatory conformity mark for products sold within the European Economic Area (EEA) that indicates compliance with EU health, safety, and environmental standards. Manufacturers must declare that their products meet all legal requirements for CE marking, which is regulated by the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. CE marking is required for specific products that fall under the scope of the “New Approach Directives”, which outline the necessary requirements and procedures for CE marking. It’s the manufacturer’s responsibility to determine if their product requires CE marking. In some cases, European importers, distributors, and customers may demand CE marking from their global supply chain. During the COVID-19 pandemic, companies worldwide have been manufacturing personal protective equipment (PPE) like surgical gowns, masks, gloves, hand sanitizers, and surface cleaners, and exporting them to Europe, where CE marking certification is required to meet regulatory requirements.
The benefits of CE marking include:
- Access to 27 European countries
- Meeting the criteria for new customer relationships
- Capturing the European market
- Improving customer confidence and credibility
The CE marking process involves:
- Identifying if the product falls under the scope of CE marking directives
- Determining the appropriate CE marking route (notified or unnotified body) based on customer requirements and product use
- Gathering evidence that the product meets the essential requirements of the directives
- Conducting assessments and testing to ensure compliance with applicable standards
- Compiling technical documentation (Technical File or Technical Construction File) covering design, development, manufacture, and conformity aspects
The cost of CE marking
The cost of CE marking varies depending on the organization’s size, complexity, and location. It’s best to contact a certification body or a consultant to get a customized quote.
