The CE mark was introduced to show that a product complies with the appropriate directives and standards in Europe.
CE marking is required for products sold on the market in 30 countries that make up the European Economic Area (EEA), including European Union member states, as well as other countries such as Switzerland and Turkey.
In this article, we take a look at exactly which products need CE marking, discuss when CE marking isn’t needed, and offer guidance on which directives apply to your product.
Which products need CE marking?
CE marking is mandatory for products that are covered by at least one of the New Approach Directives. There is more information on these directives later in this article.
Even if a product has been manufactured outside the EEA, affixing the CE mark is mandatory if it is being sold in the EEA and comes under the scope of a directive requiring CE marking.
Product categories that require CE marking:
- active implantable medical devices
- appliances burning gaseous fuels
- cableway installations designed to carry persons
- eco-design of energy-related products
- electromagnetic compatibility
- equipment and protective systems intended for use in potentially explosive atmospheres
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- lifts
- low voltage
- machinery
- measuring instruments
- medical devices
- noise emission in the environment
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- pyrotechnics
- radio and telecommunications terminal equipment
- recreational craft
- safety of toys
- simple pressure vessels
When is CE marking not required?
CE marking is not required for products being sold outside the EEA, Switzerland or Turkey. In other countries, different standards will need to be complied with, although these may be similar to CE marking requirements.
In the European market, there are some product categories to which CE marking does not apply:
Product categories that do not require CE marking
These include, but are not exclusive to:
- chemicals
- cosmetics
- foodstuffs
- pharmaceuticals
IES’s on-site CE marking service ensures that your equipment and products meet the requirements of standards such as the EMC Directive, LVD Directive and Machinery Directive.
Which directives apply to your product?
There are 23 directives set out by the European Commission which apply to products that require CE marking. One or several of these directives may apply to your product.
Directives that apply to CE marked products
- ATEX - Directive 2014/34/EU
- Cableway installations - Regulation (EU) 2016/424
- Civil Explosives - Directive 2014/28/EU
- Construction products - Regulation (EU) No 305/2011
- Electromagnetic Compatibility - Directive 2014/30/EU
- EU fertilising products – Regulation (EU) 2019/1009
- Gas appliances - Regulation (EU) 2016/426
- In vitro diagnostic medical devices - Regulation (EU) 2017/746
- Lifts - Directive 2014/33/EU
- Low Voltage - Directive 2014/35/EU
- Marine Equipment - Directive 2014/90/EU
- Measuring Instruments - Directive 2014/32/EU
- Medical devices - Regulation (EU) 2017/745
- Non-automatic Weighing Instruments - Directive 2014/31/EU
- Personal protective equipment - Regulation (EU) 2016/425
- Pressure equipment - Directive 2014/68/EU
- Pyrotechnic Articles - Directive 2013/29/EU
- Radio equipment - Directive 2014/53/EU
- Recreational craft and personal watercraft - Directive 2013/53/EU
- Restriction of Hazardous Substances in Electrical and Electronic Equipment - Directive 2011/65/EU
- Simple Pressure Vessels - Directive 2014/29/EU
- Toy Safety - Directive 2009/48/EU
- Transportable pressure equipment - Directive 2010/35/EU
If you are preparing a product for sale on the market in the EU, you’ll need a conformity assessment procedure to ensure that it’s compliant and can be CE marked.
IES offers a worldwide, on-site CE marking service to help you achieve compliance. Contact us today to find out more.
