Your access to the EU market can be arranged via CE certification and affixing the CE Mark to your product.
Trading your product on the European Market may result in numerous questions along the process. Economic operators (manufacturers, importers, distributors) will have to deal with a jungle of information on CE Marking, requirements and standards. The CE marking Directives and Regulations list is extensive. In order to be able to affix the CE marking on your product, it is of the utmost importance to comprehend the full scope of the CE Marking. Let us help you in the process that will lead to affixing the CE marking on your product.
The CE Marking process
The CE Marking process is a process which authorizes to affix the CE Mark on a product. The CE marking is a key indicator of a product’s compliance with the European Union (EU) health, safety and environmental protection directives and regulations. It is preferable to know these requirements on day 1 of the development stage. Nonetheless, it is possible to issue a CE Mark for ready-to-use products. With A CE Mark, your product is now ready to be traded freely within the European Economic Area (EEA).
If your product comes under the scope of a directive requiring CE marking, you must ensure the product complies with the applicable requirements and affix the CE mark before placing it on the market in the EU. This also applies if your product is manufactured outside the EU. Moreover, second-hand products from outside the EU that are placed in the EU market for the first time, also require CE marking. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark. The CE marking enables the free movement of products within the European market. EU Member States are not allowed to restrict the placing on the market of CE-marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product.
The CE mark can not be affixed to products that are not covered by the relevant European directives.
By affixing the CE mark, you take full responsibility for your product’s compliance with the requirements of the relevant directives;
Other markings may be affixed to the product as long as such markings do not create confusion with the CE mark in form or meaning.
How to affix the CE mark?
The CE mark is a marking that consists of the initials ‘CE’ in the following form:
The CE marking must be visible, legible and indelible. The CE marking must consist of the initials “CE”, both letters should have the same vertical dimension and be no smaller than 5mm (unless specified differently in the relevant product requirements). If the size is enlarged, the letters CE must be in proportion to the standard version as shown. There are no specific color requirements for the letters and background of the CE mark. So it is not required to print the letters ‘CE’ in black against a white background. However, the color schemes for the foreground and background should be sufficiently complementary, so that the CE logo is clearly visible.
Products that need CE Marking
- active implantable medical devices
- appliances burning gaseous fuels (gas appliances)
- cableway installations designed to carry persons
- energy-related products
- electronics and active components
- equipment and protective systems intended for use in potentially explosive atmospheres (ATEX equipment)
- explosives for civil uses
- fertilizers
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- lifts
- low voltage equipment (electrical material)
- machinery
- measuring instruments
- medical devices
- outdoor equipment producing noise
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- pyrotechnics
- radio and telecommunications terminal equipment
- recreational craft
- toys
- simple pressure vessels
The CE marking is not required for the following type of products, for example:
- chemicals
- cosmetics
- foodstuffs
- pharmaceuticals
Countries in the EU and EEA
The European Union (EU) is an economic and political union of 27 countries. It operates an internal (or single) market which allows free movement of goods, capital, services and people between member states.
The EU countries are:
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
The European Economic Area (EEA)
The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EU’s single market.
Switzerland is not an EU or EEA member but is part of the single market. This means Swiss nationals have the same rights to live and work in the UK as other EEA nationals.
Enforcement of CE marking and sanctions
When a product bears the CE mark it has free access to the market. The EU Member States’ authorities are not allowed to have conditions for market access. However, that does not mean that the authorities have no right to investigate the product’s compliance. Not only can they investigate, but they can also take measures against infringements. These measures may include withdrawal, recall of products, penalties, and criminal sanctions (such as fines and imprisonment) wherever necessary.
Please note that there is not a single, European Union enforcement agency or service. Enforcement of CE marking legislation is performed by national market surveillance authorities of the EU Member States. Enforcement is done in accordance with their national laws and procedures. These national market surveillance authorities work together closely. They share information about non-compliant and unsafe products. They also coordinate their market surveillance campaigns. If a non-compliant CE-marked product is discovered in one of the EU countries, all the other market surveillance authorities will be informed about it within 24 hours.
In Six Steps towards the successful Certification of your product
Which requirements apply to your products? Which tests and certifications are really necessary? (Which tests and certifications can be skipped, or done in-house?) Can you leverage your suppliers product compliance documentation?
We can help our clients achieve CE marking for their products within a limited timeframe. Depending on the client’s requirements, we can provide both complete CE Certification and assistance on any single stage of the process, whether it is risk assessment or the drafting and verifying of technical documentation.
Depending on the product category, the plan of action for obtaining CE Marking varies. The general plan of action contains the following six steps:
1. Check which EU Directive(s) applies to your product
2. Search for essential requirements for your product
3. Determine if the product requires Notified Body assessment
4. Assess product conformity
5. Draft and maintain technical files
6. Draw up the Declaration of Conformity and affix the CE marking
What about UKCA Marking?
In the same way we help our clients achieve CE certification, we can help in UKCA certification. We can provide both complete UKCA Certification and assistance on any single stage of the process, whether it is risk assessment or the drafting and verifying of technical documentation.
Depending on the product category, the plan of action for obtaining UKCA Marking is similar to the CE Marking. The general plan of action contains the following six steps:
1. Check which UK Regulation(s) applies to your product
2. Search for essential requirements for your product
3. Determine if the product requires Approved Body assessment
4. Assess product conformity
5. Draft and maintain technical files
6. Draw up the Declaration of Conformity and affix the UKCA marking
Ask us anything
In case you plan on entering the European Economic Area, we will be glad to guide you in the Certification process. If you have any questions regarding CE Certification or the classification of your product, please, feel free to contact us directly.