CE marking self-certification: expectations vs. reality
Thinking about CE marking self-certification? Here’s what you should know. Before you can sell your product within the European Union, it must obtain the CE mark, meaning that it meets EU safety, health, and environmental protection standards. An important decision manufacturers are faced with is whether (if possible) one should self-certify their products, or whether to involve a third party. We’ve outlined the basics to help you decide whether self-certification is the right choice for you.
What is self-certification?
As the name implies, self-certification is you (the manufacturer) assessing the conformity of your products yourself. This includes carrying out a conformity assessment, setting up a technical file, issuing a declaration of conformity, and affixing the CE mark logo to your product. Manufacturers for most products can affix the CE mark without the involvement of a third party. Should you perform the required conformity assessments and affix the CE mark yourself? Read on.
How do I obtain the CE mark for my product?
Before deciding whether self-certification is the route you want to take, let’s review what it means to affix the CE marking to your product. According to the European Commission, manufacturers must follow these 6 steps:
- Identify the applicable directive(s) and harmonised standards
- Verify product-specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE mark logo and draw up the declaration of conformity
Can I self-certify my product?
In most cases, if a conformity assessment by a notified body is not necessary, manufacturers can certify their products themselves (given that they apply the European harmonized standards during the conformity assessment). For example, machinery that is not classified as high-risk and most Class I medical devices do not require a notified body. However, even identifying whether a notified body is needed for certification of machinery, electronics, medical devices or construction products is complicated and best determined through consulting a professional.
Should I self-certify my product?
CE marking self-certification may sound tempting to manufacturers who think it will avoid added costs of working with a third party. However, CE marking directives and testing processes are notoriously complex. Consider the following steps that you will have to undertake:
- Define the legal framework applicable for your product
- Identify which assessments are required for your product
- Perform the self-assessment
These steps can be tedious and time-consuming, and time is of the essence when your product is ready for market access. Testing processes for electronics and machinery are complex, and not knowing which test facilities are appropriate can be an expensive mistake. Experts in certification provide an efficient CE marking strategy, specific to your product that guarantees compliance. They carry out the steps to assure the quality and safety of your product while you focus on other matters. Therefore, if you want to ensure that your product enters the market before your competitors do, it is best to work with a third party for a thorough and efficient certification process.
How can a third party help?
Companies with expertise in certification can help you avoid the time-consuming process of affixing the CE mark yourself. Also, they remove the possibility of penalization and other complexities if your product does not meet the relevant standards. Third parties ensure an efficient certification process by providing the following:
- Expertise in certification and knowledge of applicable rules & regulations
- Adeptness in technical record-keeping necessary for verification and audit processes
- Knowledge about the timeline of all processes necessary to affix CE marking
- Ability to decipher the technical language in documentation
- Assurance of quick market access
- Awareness of the importance of conformity and of consequences if a product does not meet regulations
The benefits of third-party assistance
As a manufacturer, it is your responsibility to ensure that your product meets EU safety requirements before putting it on the market. Whether you go about it alone or involve a third party is your decision. Certification, however, is time-intensive and complex. Ensuring that your product meets compliance standards is crucial for the safety of future users and for avoiding liability as a manufacturer. Working with experts in the field saves time and energy- priceless commodities when getting a product on the market.
Why Certification Experts?
For more than 25 years, we have helped designers, manufacturers, exporters, importers and distributors get their products on the market quickly, and efficiently. We continuously strive for the best experience for our customers by being fast, flexible, and customer-focused. We ensure that your products comply with all legal safety requirements by executing the steps relevant to your project, including:
- On-site inspections
- Legal solutions
- Information research
- Authorized representation
Whether you are new to the world of product certification or have questions concerning a specific part of the process, Certification Experts is here to help.
- CE Marking
- Certification Experts
- Authorized Representative
- CE Declaration of Conformity
- Competent Body (Notified Body)
- Technical File
- Information on the Product
- USA compliance
- Self certification
- Export to China
- Summary Directives
- Medical Devices