What is the CE Mark and Why is it Used?
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU (European Union) directives as applicable for that product. Examples are the Electrical Safety (Low-Voltage Directive or LVD), Electromagnetic Compatibility (EMC) and Machinery directives.
The CE mark is required for electrical and electronic products manufactured anywhere in the world that will be sold in the European market.
There is also a stringent medical devices regulation and there are environmental protection directives (RoHS, REACH etc). Products sold within the European Economic Area (EEA) are required to be CE marked. If the product is not CE marked then it can not legally be sold in any of the 27 member states of the European Union.
CE marking is a way for manufacturers to show that their product meets EU rules on health, safety and environmental protection. Manufacturers who sell
The CE mark means a product has been tested or evaluated for compliance with all relevant CE technical standards and meets the applicable CE directives. It also means a Declaration of Conformity (DoC) citing the applicable CE directives and technical standards has been made by the manufacturer for this product.
Manufacturers are responsible for carrying out the necessary conformity assessment procedures, normally using an ISO 17025 accredited lab such as Green Mountain Electromagnetics, to assist in ensuring the EMC and safety of their products. The manufacturer should work with this accredited lab to determine which directives and standards apply to the product. Then the lab carries out the necessary tests of the product and reports to the manufacturer. The manufacturer then makes a declaration that the product meets all relevant requirements.
What types of products usually require CE marking?
The following are examples of product categories that usually require CE marking: machinery, electrical equipment, radio equipment, diagnostic medical devices and certain toys. Any product that may cause harm to the public or affect the environment needs to be assessed to the applicable CE directives.
How to obtain the CE mark?
The manufacturer places the CE-Mark on products that are not notably hazardous. But first, products should undergo testing before they are CE-marked. A manufacturer then issues a CE DoC to the applicable EU directives after he is sure the product passes the tests and meets all the applicable technical standards. This includes testing for electrical safety, machinery safety, electromagnetic emissions, electromagnetic immunity and many more. Please see our CE Marking page for more information on CE requirements and maintaining your CE Certificate.
Do you need to pay any fees?
Yes. Manufacturers must pay labs which test their products against the various CE directives and then report back to the manufacturer that their product meets all relevant requirements. Products can be tested internally by the manufacturer to get a sense of whether it will comply, but it is not recommended for supporting a CE-Mark. Most fully compliant test setups are too complex for an in-house team. Certification
Fees will vary depending on the type of product, variety of inspectors involved, size of company, amount of time consumed by testing, and applicable directives.
We would be more than happy to have a chat about your product and provide you with an estimate after learning more about your requirements.
How do you affix the CE marking?
The CE mark can be created by the manufacturer using the template supplied in the EU directives, or by purchasing ISO compliant stickers online.
The CE marking must be affixed visibly, legibly and indelibly to the product. If it is impossible to affix the CE marking on the product itself, then it has to be affixed to a label or an accompanying document that can easily be found when needed.
The CE mark should consist of both the letters "CE" and be no smaller than 5mm.
What are CE marking requirements?
Manufacturers must abide by the following requirements when obtaining their CE mark:
Declaration of Conformity (DoC) - Issued by the manufacturer indicating that the product complies with all relevant CE directives. Labels and instructions - The DoC must be included with any labels or instructions accompanying the goods. Product ID number - A unique reference number must be included for each batch of products produced. This is to allow traceability in the event of a recall or safety issue.
How long does CE Marking last?
The CE marking is legally valid as long as the product has not been modified in such a way that brings it outside the scope of the standards (e.g. through a substitution of components, unless the changes are deemed to be minor). When this occurs or the standards are updated, the manufacturer needs to check if the relevant new requirements are applicable and apply for re-assessment by an accredited lab.
A manufacturer is advised to re-check the validity of their DoC’s every three years at a minimum
CE Marking: Key Facts
All products to be marketed inside the EU (European Union) need to be safe for persons, domestic animals, property and environment.
Manufacturers / Suppliers
The responsibility to CE-mark a product falls on manufacturers and their authorized representatives.
Market Surveillance Authorities
Member States have designated National Market Surveillance Authorities that monitor compliance with CE-Mark directives. Failure to comply with the directives can result in fines and market exclusion.
What is an ISO 17025 Accredited Lab?
An ISO 17025 Accredited Laboratory is an organization that has met the requirements of ISO 17025, which includes the competence to carry out testing of equipment to CE-Mark standards.
The ISO 17025 Accredited Laboratory must have documented policies on quality management, personnel qualification, document control, measurement uncertainty and other risk based approaches that are recognized internationally.
GME is an ISO 17025 Accredited Laboratory.
When a product is considered too hazardous to allow manufacturer’s to issue a DoC, A notified body is used for CE-Marking a product. Examples are chainsaws, automobiles and intravenous medical equipment.
All electronic products to be marketed inside the EU need to operate with affecting other equipment by producing electromagnetic emissions. Also, all electronic products must also be able to operate properly in the expected electromagnetic environment.
Conformity Assessment Procedure
Conformity Assessment Procedures are documented procedures that manufacturers must follow to ensure a product meets all requirements.
What is the difference between a Declaration of Conformity and a Certificate? Manufacturers can choose whether they want to have a DoC or a certificate issued for their product. In some cases, only one method will be applicable.
Have a Question about CE Marking?
We would be more than happy to answer any questions that you have about product testing for CE marking, including process, timeline and pricing. Reach out today for a no-cost consultation.