The CE mark acts as a "trade passport" for the European marketplace, allowing manufacturers to freely circulate their product throughout the European Economic Area (EEA).
CE marking is equivalent to a standardisation mark, and it is affixed to manufactured products that comply with European standards. Manufacturers will greatly benefit from the fact that there is now only one set of regulations and processes to follow when designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be tailored to the individual requirements of each country.
The Core Benefits of CE Certification for Manufacturers
Globally Recognised Certification
The CE Mark is a globally recognised standard which indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. The products manufactured under European Directives and Regulations are affixed with a CE logo and can be sold in the global market without any legal barrier. It is required for products manufactured anywhere in the world that are then marketed in the EU.
As CE marking represents such high standards, many manufacturers use it in the wider world to qualify for a Free Sales Certificate – a document that guarantees the manufacturer and product alike meet the various health and safety requirements outlined in the CE marking process (especially for MDD and IVD devices).
Assurance about Safety and Protection
A product’s CE marking is seen as the gold-standard in industry and consumer market quality in Europe. It is a symbol of excellent quality, rigorous testing, and strict adherence to health and safety norms and laws.
The product's manufacturer bears sole responsibility for declaring conformity with all requirements. You do not require a licence to apply the CE marking to your goods, but you must first:
- ensure compliance with all applicable EU-wide requirements
- determine whether you can assess your product yourself or if a notified body is required
- compile a technical dossier showing conformity
- draft and sign an EU declaration of conformity
Once your product bears the CE marking, you must send all relevant information and supporting paperwork to the national authority upon request.
Streamlined product trading
As a means of boosting trade between its member states, the EU introduced CE certification. A CE mark acts as a 'trade passport' for the European marketplace, allowing manufacturers to freely circulate their products throughout the EEA. Thus, manufacturers are able to trade their products beyond their existing markets and meet all EU health and safety requirements.
Standardised marking – simplified manufacturing and adherence to regulations
The use of a standardised quality and safety marking system throughout all European member states allows manufacturers to focus on one set of standards rather than adapting their product to different rules in each market. Helping manufacturers and traders in overcoming potential customs, safety, and quality issues.
CE marking allows free movement and sale of goods throughout the European Economic Area. For you to grow your business and distribute your products in the European market, CE-marking is mandatory for many products.
CE marking is a type of standardised marking that ensures the product is being manufactured as per the EU’s directives and regulations. Having CE marking is not only a regulatory requirement but also one customers look for. Nowadays, customers research every aspect of the products, including quality and compliance with safety regulations before purchasing.
Did you know?
We are able to support you with achieving CE Mark certification as part our full-service medical kitting solution. We are able to support you with achieving CE Mark certification as part our full-service medical kitting solution! Use the meeting link below to discuss how we can help you.