A first approach to the CE Marking.
Be sure to check our frequently asked questions section.
The CE marking is the evidence given by the manufacturer that your products are in compliance with the requirements set out in EU directives (commonly referred to as “New Approach Directives”) applicable to them.
The affixing of the CE marking on a product allows its free movement within the European Economic Area (EEA)
The conformity assessment procedures of the products with the directive standards aim to ensure that the products placed on the market comply with the requirements expressed in the policies, in particular concerning the health and safety of users and consumers. Such compliance applies not only to the essential obligations, but also to the specific obligations laid down in the directives.
The conformity assessment is based on:
- Activities developed by the manufacturer under the factory production control, including product design and development, where applicable
- The activities carried out by third parties (typically a notified body), which may include, among others, initial type tests and approval of quality assurance or production system, in conjunction with the activities of the manufacturer in the factory production control
- Activities developed by third parties (typically a Notified Body), which may include, among others, initial type examinations and quality assurance or production system approval, in conjunction with the manufacturer’s activities related with factory production control.
The CE marking must be affixed by the manufacturer or his authorised representative established within the Community and, exceptionally and with proper justification, by the person responsible for placing the product in the EU market.
The CE marking is applicable to all products covered by at least one of the New Approach Directives.
Therefore, you must check if the product you want to put on the market in the EEA is within one of the directives that require the affixing of CE marking. The list of product categories covered by CE marking is presented below:Therefore, you must check if the product to be placed on the EEA market is within one of the directives that require CE marking. Below is the list of product categories by CE marking:
- Gas appliances
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Pyrotechnic articles
- Lifts
- Hot-water boilers fired with liquid or gaseous fuels
- Electromagnetic compatibility
- Active implantable medical devices
- Medical devices
- Medical devices: in vitro diagnosis
- Ecodesign and energy labelling
- Recreational craft
- Noise emissions
- Low-voltage electrical equipment
- Personal Protective Equipment – PPE
- Radio communication and telecommunication terminal equipment
- Pressure equipment
- Explosives for civil use
- Cableway installations designed to carry persons
- Measuring instruments
- Non-automatic weighing instruments
- Construction products
- Simple pressure vessels
- Safety of machinery
- Safety of toys
Products that do not require CE marking include:
- Chemicals
- Cosmetics
- Pharmaceuticals
- Food
See also “WHICH DIRECTIVES AND REGULATIONS ARE APPLICABLE TO PRODUCT CE MARKING?”
NOTE: Depending on the complexity of the products, official positions and clarifications are often published by competent authorities on the framework of a given product or family of products, for example, which are the metallic structures/components subject to CE marking under the construction products regulation. (Reg. EU 305/2011) in accordance with standard EN 1090-1.
The CE marking is a requirement for products placed on the European Economic Area (EEA) market, regardless of where they are manufactured. The EEA consists of the European Union (EU) Member States on the one hand, and by three of the four countries of the European Free Trade Association (EFTA) on the other – Liechtenstein, Iceland and Norway (called EEA-EFTA countries).
Germany | Croatia | Estonia | Hungria | Liechtenstein | Poland | Sweden |
Austria | Denmark | Finland | Ireland | Lithuania | Portugal | |
Belgium | Slovakia | France | Iceland | Luxembourg | United Kingdom | |
Bulgaria | Slovenia | Greece | Italy | Malta | Czech Republic | |
Cyprus | Spain | the Netherlands | Latvia | Norway | Romania |