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 include Electrical Safety (Low-Voltage Directive or LVD 2014/35/EU), Electromagnetic Compatibility (EMC Directive (2014/30/EU) and the Machinery Directive (2006/42/EC).
The CE mark is required for electrical and electronic products manufactured anywhere in the world that will be sold in the European market.
Products sold within the European Economic Area (EEA) must obey strict medical device regulations (MDR 2017/745) and environmental protection directives such as RoHS 3 (EU 2015/863) and REACH (Regulation EC No. 1907/2006). Products must be CE-marked to indicate that it complies with all applicable laws. If the product does not bear CE marking and does not meet CE marking requirements, then it can not legally be sold in any of the 27 member states of the European Union.
CE marking is the method for manufacturers to show their product meets EU rules on health, safety and environmental protection. The CE mark means a product has been tested or evaluated for compliance with all relevant CE technical standards and meets the applicable CE marking directives. It also means a Declaration of Conformity (DoC) citing the relevant directives and technical standards has been made by the manufacturer for the product.
Manufacturers are responsible for performing conformity assessment procedures, commonly with the help of an ISO 17025 accredited lab such as Green Mountain Electromagnetics. This is to ensure that the product meets all relevant CE technical standards and EMC safety requirements.
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. With supporting documentation 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 subject to 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?
It is the manufacturer's responsibility to place the CE-Mark on products that are not notably hazardous. Before a CE Mark is placed on a product, it should undergo testing.
After successful testing, a manufacturer is then able to issue a CE DoC for the product in accordance with EU directives. This DoC covers electrical safety, machinery safety, electromagnetic emissions, electromagnetic immunity, and many other areas. For a full breakdown of CE requirements and information on maintaining your CE Certificate, visit our CE Marking page.
Do you need to pay any fees?
Yes. Manufacturers must pay labs to test their products against the various CE directives. The lab then reports back to the manufacturer whether the product conforms to all relevant requirements.
Products can be tested internally by the manufacturer to get a sense of whether they 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 the 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 substitution of components unless the changes are deemed to be minor).
If a modification of a product extends beyond the scope of the standards, 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 DoCs 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 the manufacturer and their authorized representative.
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.
ISO 17025 Accredited Laboratory
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. An 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.
Electronic products sold within the European Union must not cause interference with other equipment through electromagnetic emissions. Furthermore, all electronic products must be able to perform correctly in their expected electromagnetic environment.
Conformity Assessment Procedure
Conformity Assessment Procedures are documented procedures that manufacturers must follow to ensure a product meets all applicable regulations, standards and directives.
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.
When a product is considered too hazardous to allow manufacturers to issue a DoC, A notified body is used for CE-Marking the product. A notified body is an independent third-party certification body. Examples of products in this category include chainsaws, automobiles, and intravenous medical equipment. After a successful assessment by a notified body, the product can be CE-marked and released onto the market.
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.