- What is CE marking?
- What is the CE marking process?
- What are the New Approach Instructions?
- What is a Notified Body?
- What are the benefits of CE marking?
- Why choose BSI?
- What is the Kitemark?
What is CE marking?
- Identify the Instruction (s) that are applicable to your product.
- Identify the compliance assessment procedure for your product and Instruction
- Determine the dates by which you must take action.
- Identify if there are any Harmonized European Standards applicable to your product.
- Ensure the product complies with all the essential requirements of the Instruction(s).
- Identify whether independent assessment of your compliance is required by a Notified Body
- Maintain Technical Documentation required by the Instruction(s).
- Prepare the Declaration of Conformity and the required supporting evidence.
- Check that no other purely national requirements exist in the country where the product is to be sold.
- Affix CE marking on your product and/or packaging.
What are the New Approach Instructions?
The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Instructions. New Approach Instructions provide controls on product design and above all, seek to harmonize product safety requirements across Europe.
The instructions cover a very wide range of product areas including toys, medical devices and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user.
Throughout Europe, where a New Approach Instruction is in force, it is necessary for the manufacturer to CE mark their product. CE marking requirements vary from Instruction to Instruction, and even within Instructions.
Third-party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer's unverified claim is all that's asked for. But beware! If you claim your product complies and it doesn't, you will be prosecuted. Where a Instruction requires products and/or systems to be independently tested, certified, or inspected, this must be done by a "Notified Body" or "Competent Body".{sp}
What is a Notified Body?
A Notified Body is an organization that has been nominated by a member Government and Notified by the European Commission. A Notified Body will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the compliance assessments.
The primary role of a Notified Body is to provide services for compliance assessment on the conditions set out in the New Approach Instructions in support of CE marking. This normally means assessing the manufacturers compliance to the essential requirements listed in each instruction. Conformity assessment can be inspection, quality assurance, type examination or design examination, or a combination of these. BSI is a Notified Body for many European Instructions.
What are the benefits of CE marking?
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU instructions.
Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.
Why choose BSI?
As such BSI has a wealth of experience in helping companies to attain CE marking for their products. Our technical experts are available to help guide you through the process to make it as painless as possible.
What is the Kitemark?
The Kitemark is a voluntary, independent third-party mark that offers peace of mind for both the consumer and the specifier.
To achieve Kitemark certification requires a manufacturer to have a comprehensive quality management system, based on ISO 9001:2000 or recognized factory production control system combined with initial product type testing and regular audit testing. Once achieved, the Kitemark can serve as an enhanced marketing tool in a competitive market, by demonstrating an ongoing commitment to quality and safety.
CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Instructions. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials "CE" do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Instruction(s).
At BSI, we have a team of experts who understand precisely what each Instruction requires for each product. We can help take you through the CE marking (CE mark) process in these simple steps:
