Planning to sell your products in the European Union?
Most electrical, electronic, machinery, medical, toy and many other products must comply with European legislation before they can be legally placed on the market.
We help manufacturers, importers and product developers navigate the complete CE Marking process—from determining the applicable directives and standards to preparing technical documentation, coordinating testing and ensuring your product is ready for the European market.
Whether you are developing a new product or preparing an existing product for EU market entry, we help simplify the certification process while avoiding unnecessary delays and costs.
Selling products in Europe often raises questions.
Which directives apply?
Which standards must be followed?
Do laboratory tests need to be performed?
Is a Notified Body required?
What documentation must be prepared?
Many manufacturers spend weeks trying to interpret complex European legislation before they even know where to begin.
We simplify this process by determining exactly which requirements apply to your product and guiding you through every stage of CE Marking.
The CE Marking process
The CE Mark is a declaration by the manufacturer that a product complies with all applicable European legislation.
For products covered by CE legislation, the CE Mark is generally required before the product can be legally placed on the market within the European Economic Area (EEA).
Depending on the product category, compliance may involve product testing, technical documentation, risk assessments and, in some cases, involvement of a Notified Body.
The exact requirements depend entirely on the product.
Why is CE Marking Important?
CE Marking allows products that comply with European legislation to circulate freely throughout the European Economic Area.
Without proper compliance documentation, products may be:
• Stopped by customs
• Removed from online marketplaces
• Recalled by market surveillance authorities
• Subject to fines or enforcement measures
By addressing compliance requirements early during product development, manufacturers can significantly reduce project risks, avoid unnecessary testing and shorten their time to market.
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 CE Mark generally provides access to all EU Member States and the wider European Economic Area (EEA), including Iceland, Liechtenstein and Norway.
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
What happens if products do not comply?
Market surveillance authorities throughout Europe actively monitor product compliance.
Where non-compliant products are identified, authorities may require corrective actions, product withdrawals, recalls or impose administrative or criminal penalties depending on national legislation.
Preparing proper technical documentation and following the correct conformity assessment procedure significantly reduces these risks.
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?
Selling products in Great Britain? In the same way we help our clients achieve CE certification, we can help in UKCA certification for the UK. 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
Why Choose us?
Unlike testing laboratories, we provide independent compliance guidance tailored to your specific product.
Our services include:
✔ Applicable directive assessment
✔ Harmonised standards identification
✔ Testing strategy
✔ Laboratory coordination
✔ Technical documentation
✔ Risk Assessments
✔ Declaration of Conformity
✔ CE Marking support
✔ Ongoing compliance advice
We help manufacturers achieve compliance efficiently while reducing unnecessary testing, project delays and certification costs.
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.