The meaning of CE Marking, what it does and what it represents is something that is often misunderstood by many people. Whether you are new to CE marking, operate a business and are looking to learn more about the process or are just wanting to refresh your knowledge, here we explain the conformity process in easy to understand steps.
What Does ‘CE’ Mean?
CE stands for ‘Conformité Européene’, a French phrase that translates to ‘European Conformity.’ Although commonly referred to as a ‘CE Mark’ in articles on the subject, the correct and official term is ‘CE Marking’ which is used in the numerous product directives.
What Does CE Marking Mean?
A CE mark on a product is a symbol that indicates its compliance with the relevant, essential requirements of EU health, safety and environmental protection legislation. For UK manufacturers and exports, CE Markings are vital in ensuring the free movement of their products within the European Free Trade Association (EFTA) and the European Union (EU) single market and it’s because of this it has earnt its nickname of ‘a passport for products’.
What Types of Products Need CE Marking?
The process of determining if a product does or does not require CE Marking can be somewhat complex and can depend on things such as the countries they are intending on introducing them into and whether or not they are within the EEA or EFTA.
Here are some of the product categories that are covered by at least one of the CE marking directives:
- Active implantable medical devices
- In vitro diagnostic medical devices
- Construction products
- Electrical equipment
- Electronic equipment
- Equipment and protective systems used in explosive atmospheres
- Explosives for civil use
- Gas appliances
- Measuring Equipment
- Medical devices
- New hot water boilers
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio and Telecommunications terminal equipment
- Recreational craft
- Simple pressure vessels
The following product categories do not require CE Marking:
The CE Marking Process Explained
The CE marking process can often be very overwhelming for manufacturers who without experience and knowledge on the standard, can get lost in the maze of regulatory directives, documentation and procedures.
Here is a brief insight into the process of CE Marking and the steps and processes that are involved.
The process itself and the exact number of steps needed will depend on the relevant directives and their product safety requirements, but the main steps of CE Marking can be broken down into:
- Identifying the applicable directive(s)
- Determine the relevant standards
- Notified body assessment (where applicable)
- Testing of product (external or internal)
- Compile technical documentation
- Create a Declaration of Conformity for the product
- Labelling and marking the product
- Step 1 – Identifying the Applicable Directive(s)
In the first step it is important to identify whether the product needs to be CE Marked, if it can be, and the scope of the relevant directives and regulations that are applicable to it. The EU directives will state the essential requirements a product must meet in order to enter the EU single market.
Each CE marking directive comprises of a legal document which for those who are not proficient in CE Marking can be difficult to interpret and understand. In most cases non food products will fall into the scope of at least one directive, but it can be 2 or more and the manufacturer must comply with the requirements in order to receive a CE marking approval.
- Step 2 – Determine the Relevant Standards
In order to place products on the market, manufacturers must also identify applicable standards which will specify the vital requirements and technical specifications that products must comply with in order to meet the safety standards of the relevant CE marking directive(s).
Within each CE marking directive, there are a number of standards which are “approved” to cover the essential requirements, these are called harmonised standards. With one or several directives a standard can be harmonised which means that when a product meets the requirements in a harmonised standard, it will automatically meet the necessary requirements in the corresponding directive.
- Step 3 – Notified Body Assessment (if applicable)
The compliance assessment process of certain products with the Europeans standards can require the involvement of third-party or ‘independent notified body’. A Notified Body is an EU accredited organisation whose roles is to evaluate and assesses the CE compliance of certain products and evaluate whether the product complies with the relevant legislation in force. They will also carry out conformity related tasks such as test reports, facilities and product inspections and reviews of technical files.
If a Notified Body is required, then in order for the assessment to run smoothly, simplify proceedings and save time it is advisable to consult with a CE Marking expert and submit any applications as early as possible.
- Step 4 – Testing of Product (external or internal)
In order to verify that the product meets the requirements of the relevant EU directives, it will need to undergo compliance testing either internally or externally which is determined by the type of product.
For those who do not require a Notified Body, this step can sometimes be performed inhouse, depending on the applicable product safety requirements. This step can often require estimating and documenting possible risks to customers using the product and carrying out a thorough risk analysis and subsequent risk management file.
- Step 5 – Compile Technical Documentation
This step involves compiling all of the relevant information, data and results from the testing process into technical documentation also known as a ‘technical file’. This should contain everything needed to demonstrate that a product displaying the CE marking symbol meets the necessary product safety requirements and will include information about the design, production of the product and its uses.
The documentation should typically contain the following files:
- A general product description.
- Design information such as – design drawings, circuit diagrams, mechanical illustrations, component lists and manufacturing documentation, etc.
- Detailed descriptions explaining the abovementioned drawings and making the design information, installation description and user manual easy to understand.
- In order to verify compliance with the relevant CE Directive(s), a list of all the standards used either fully or partially is needed.
- Additional documents, such as calculations, simulations and test reports, etc.
- A copy of the EU Declaration of Conformity.
Manufacturers are required to store the technical file for a certain period after the last product is sold which is often around 10 years but the exact timeframe will be specified on the relevant CE marking directive(s).
The technical documentation must always be available and should it be required by the national market authorities must be provided immediately. In the event that the documentation is incomplete, the manufacturer will usually be given 14 days to secure the missing documents.
- Step 6 – Create a Declaration of Conformity for the Product
Once the technical documents are ready and it has been established that the EU’s requirements have been met, it is time to complete a declaration known as the ‘Declaration of Conformity’. This formally states from the manufacturer that the product meets all relevant safety requirements pertaining to the applicable CE marking directives.
The Declaration of Conformity is a legal document that needs to be signed by the person responsible for undergoing and passing the CE marking process, usually the company CEO or product owner.
- Step 7 – Labelling and Marking the Product
Once the declaration is complete the manufacturer can then affix the CE mark to the products surface or data plate on the packaging. Together with the Declaration of Conformity, this marking testifies that the product is compliant with the CE marking legislation.
CE Marking Consultancy Services
If you have further questions about CE Marking then please do not hesitate to get in touch.
Our team of knowledgeable, highly experienced consultants can help to provide you with the necessary guidance and assistance needed to navigate the CE marking process, making the process to approval simpler and more efficient.