The CE marking is only required if a product is covered by one or more CE Marking Directives or Regulations adopted by the European Union (EU). These are EU regulatory documents that require the affixing of a CE mark to the products covers by them. In the overview below, also links are provided to the pages with guides on the particular directive or regulation.
Table of Contents
Overview of CE Marking Directives and Regulations
- Machinery Directive
- Low Voltage Directive
- EMC Directive
- Medical Devices Regulation
- Personal Protective Equipment Regulation
- Construction Products Regulation 305/2011
- Pressure Equipment Directive
- REACH Regulation
- Restriction of Hazardous Substances Directive (RoHS)
- ATEX Directive
- Toys Safety Directive (2009/48/EC)
- Radio Equipment Directive
- Recreational Craft and Personal Watercraft Directive
- Active Implantable Medical Devices Directive
- Explosive for Civil Use (CIVEX) Directive
- Noise Emission Directive
- Gas Appliances Directive 2009/142/EEC
- Lifts Directive 1995/16/EC
- Pyrotechnic Directive 2013/29/EU
- Measuring Instruments Directive
- Ecodesign and Energy Efficiency Labelling
Difference between ‘Directive’ and ‘Regulation’
In the overview of EU product legislation you will find references to ‘directive’ and to ‘regulation’. For example EMC Directive, Low Voltage Directive, and Personal Protective Equipment Regulation, Construction Products Regulation. What is the difference between ‘directive’ and to ‘regulation’, and does it impact your business?
Both directives and to regulations are legislative instruments at the disposal of the EU regulators. Directives and regulations can contain requirements for product groups or certain aspects of products. The format of both are very similar. The main difference is that directives are EU documents that require to be transposed into the legislation of the EU Member States. The requirements of regulations apply directly in the countries of the EU. They do not first have to be transposed into their national legislation.
Sometimes we read that directives are more like instructions or goals given by the EU to its member countries. Each country must achieve the goal set by the directive, but they have the freedom to decide how they do it. However, this is not true. The European Court of Justice has rules that there may not be any deviation in the national laws and regulation compared to the directives. If there are, the text of the EU directive is leading.
In short, economic operators, such as manufacturers, importers and distributors, are not impacted by the difference between directives and regulations. The requirements in both are equally binding and obligatory.
Multiple directives and regulation can apply to a single product
Please be aware that more than one directive or regulation can apply to a single product. For example, electrical equipment are typically covered by 2, 3 or sometimes even more directives and regulations.
How to determine which directive or regulation applies?
To determine which directives and regulations apply, you need to open the document and look at the first articles in the text. These articles define the scope of document. Typically, these articles list the products that are covered, which are exempted, and provides terms and definitions.
Unfortunately, the EU regulator does not provide a database tool which shows the applicable regulation for a selected product or product family. That would be very easy. However, such a database would have to be updated constantly, as new products are invented all the time, and the regulations themselves are developed and amended.
Please use the provided overview to navigate to the guides. If you cannot find the applicable regulations and directives, or if you want to be sure your selection is correct, we will be glad to support you.