CE Marking and CE Certification applies to a wide variety of products and equipment across many different markets where it is made available or put into service in the EU.
There are over 20 CE Marking Directives and Regulations published by the European Commission.
If your product is within scope of one or more of these Directives and Regulations then to be eligible for a CE Certificate you need to carry out the following:
What is the CE Marking and CE Certification?
The CE (Conformité Européenne) marking is the EU’s compliance mark for products. Harmonised European product legislation covering 25 sectors of new, finished, manufactured, non-food products require the CE marking for EU single market access.
When was CE Marking invented?
Several variants of the ‘EC mark’ appeared in early single market legislation including the C-epsilon mark, CE in text and a chunkier version before settling on the final design of the ‘CE marking’ in 1993.
Can the size, shape and colour be changed?
What does it CE Marking mean?
It is a statement by the manufacturer that a product complies with all the applicable EU product legislation and can therefore be supplied anywhere in the European Economic Area (EEA.)
The EEA includes the EU, Norway, Iceland Liechtenstein, Switzerland and some related territories. For example by applying the CE marking to a typical electrical appliance like a refrigerator, the manufacturer is indicating that it complies with:
What types of products need the CE marking?
The CE marking is required on products in 25 harmonised sectors covering:
Why do products need the CE marking?
The CE marking allows the same product with a single certification to be placed on the market in any member state of the EEA without needing to meet any further national requirements.
Before the EU single market some products needed different variants and different certificates to be sold in different EU member states. These were a ‘technical barrier to trade.’ (TBT) To establish the single market, the EU divided products into groups:
Who must apply the CE marking?
Usually the manufacturer applies the CE marking when they have ensured conformity with the legislation. They can appoint an authorised representative to do it for them.
If anyone else applies the CE marking, the authorities will consider them to be the manufacturer and expect them fulfil all the obligations of the manufacturer.
What about own-brand labelled products?
If an own-brand-labeller (OBL) puts their name or trade mark on products instead of the original manufacturer’s name, then the OBL is considered to be the manufacturer and must ensure compliance and apply the CE marking.
What about imported products?
Imported products must have a responsible economic operator established in the EEA such as an importer or Authorised Representative. They must:
The EEA manufacturer is the responsible person for EEA products.
Does the CE marking mean ‘made in europe?’
No. Non-European manufacturers can put the CE marking on their products if they comply with the applicable legislation. There must, however, be a responsible economic operator in the EEA before the products are placed on the market.
What does the manufacturer have to do to get the CE marking?
They must make sure the product complies with all the requirements of the applicable CE marking directives and regulations. Some of these requirements are about the product and others are about the manufacturer’s information and procedures.
The essential requirements are about the design, manufacture, testing, and user information to minimize the risks from the product. Most legislation is about risks to health and safety but some is about risks to the environment, product performance, compatibility and measuring accuracy.
There are also administrative requirements such as:
Does a PRODUCT have to be APPROVED to be CE marked?
Not usually. Most products can be self-certified by the manufacturer by completing a declaration of conformity and applying the CE marking. Some product sectors require higher-risk products to be approved by a Notified Body (an accredited conformity assessment body) before they can be CE marked. A few sectors require this for all products. Depending on the risks, the Notified Body may need to approve the design, manufacturing, testing, or all of them.
Does a product have to be registered to be CE marked?
Not usually. Most can be placed on the market without any involvement with the authorities. Medical devices, cosmetics and chemicals may require registration or notification to authorities.
Can all products be CE marked?
No. Only products in the scope of one or more of the 25 EU directives and regulations requiring the CE mark may use it.
What about products that cannot be CE marked?
Some products have harmonised rules following similar principles but the CE marking is not required or allowed. They include:
Other products are subject to unharmonized, member state rules including:
What does a number next to the CE marking mean?
It is the identification number of the Notified Body that is involved in the production control of the product. Notified Bodies that only approve the design of a product do not have their identification number next to the CE mark.
Does a second-hand product need CE marking?
Not if it has been placed on the market in the EEA before. If it is being imported and is being placed on the market for the first time, then it must be CE marked in accordance with current legislation, whatever it’s age.
How can I check if the CE marking is genuine and the product is safe?
If the CE marking is on the same label as the manufacturer’s name, it is much more likely that the manufacturer has applied it after completing the conformity assessment. A separate CE label is a sign that someone else has applied it, who may not have ensured it complies properly.
Other indications of compliance are:
What is the penalty for selling a product without the CE mark?
Member states set the penalties for non-compliance. They vary from small fines for minor infringements, to criminal penalties for major incidents dependent on the damage and injuries caused.
Can the CE marking appear with other compliance markings on a product?
Only if the other marking is concerned with a different characteristic or objective of the product from the CE marked characteristics. For example: a separate marking can be applied for energy efficiency of a product that is CE marked for safety only. A separate energy efficiency marking cannot be applied to a product that is CE marked for both energy efficiency and safety.
Other conformity makings must not confuse or obscure the CE marking or its purpose.
There is no restriction on applying compliance marks for other regions of the world as long as the CE marking is clear.
What happens if a manufacturer puts the ce marking on a product without completing the conformity assessment properly?
This is not legitimate and is an infringement of CE marking legislation. The manufacturer and any other economic operators in the EEA making the product on the market are liable to prosecution under CE marking legislation.
Who polices CE marking?
Market surveillance authorities in each EEA member state supervise and police the legislation.
The authorities may be alerted to non-compliances by:
It is also possible for non-compliant products to remain undetected for a long time.
We have CE Marking Declaration of Conformity Templates to purchase at Product Compliance Support.
If you still need help and advice why not get in contact with our team. We can help you with all aspects to do with CE Marking and CE Certification.
We can also help with providing Authorised Representative Services for CE Marking and UKCA Marking for trading products in Europe (EC or EU) or the UK.
We have a selection of templates available on our sister site Product Compliance Support. Click the image below to access our templates shop.