The CE Mark is the European Union’s product safety mark. Unlike traditional certification schemes, the CE Marking scheme is self-declaratory. Depending on the nature of your product, you may require an EU Notified Body to oversee your engineering and production processes.
The CE Mark gives your product access to the EU market, including 31 countries, EU member states, the EEA, and EFTA. The UK and Northern Ireland also continue to accept the CE Mark in addition to their UKCA and UKNI marks.
THE CE MARK
The CE mark was created to correct a difficult problem. Before the EU was formed, every European country had its own conformity assessment policies, programs, regulations, and bodies. These technical trade barriers had to be broken down to achieve the free movement of goods in the EU. The CE Marking Scheme was created to accomplish this goal.
Standing for “Conformité Européen,” the CE mark must be on products placed on the market in any EU member state, European Economic Community (EEC), and European Free Trade Association (EFTA) country. As understood in North America, the CE mark is not a safety or certification mark. It is a self-declaratory mark, meaning that manufacturers, importers, and distributors decide if the product meets the requirements and then place the mark on it.
There are some notable exceptions to this rule, including machinery falling under Annex IV of the Machinery Directive (2006/42/EC from 31-Dec-09 onward), pressure vessels falling under the Simple Pressure Vessels Directive (2014/29/EU) and pressure vessels and equipment falling under the Pressure Equipment Directive (2014/68/EU). These directives require the involvement of a European Notified Body as part of the conformity assessment program.
All EU member states and EFTA countries are required to accept the CE Mark. While EU law allows member states to create laws and regulations beyond the EU Directives, they are also strongly discouraged from making laws that will create new technical barriers to trade. For machine builders and distributors, this means one mark for 31 countries!
Brexit
Brexit involved the UK and Northern Ireland exiting the EU. The use of the CE Mark in the UK was permitted until 2021-12-31; however, an extension to the implementation limit date to 2022-12-31 was announced in mid-2021, which has since been extended again. The new UKCA, UKNI marks, and CE Mark will be accepted in the UK and Northern Ireland. See our UKCA/NI page for more information if you are selling in the UK or Northern Ireland.
DIRECTIVES
The European Union is subdivided into General Directorates (DG) with specific responsibilities. The EU parliament in Brussels publishes Directives similar to government “Acts” in the North American system.
Machinery and related products fall under the DG Industry. There are specific directives for a wide variety of subjects. These directives use “harmonized standards,” denoted by the prefix “EN,” as the basis for conformity assessment under each directive. Where the involvement of a Notified Body is required, you have a wide selection of organizations. Lists of NBs under each directive are also available from the Directive website.
When it comes to industrial machinery, there are a few key directives that typically apply:
- 2006/42/EC Machinery (MCD) [until 2027-01]
- 2023/1230 EU Machinery Regulation [mandatory from 2027-01]
- 2014/35/EU Low Voltage (LVD)
- 2014/30/EU Electromagnetic Compatibility (EMC)
- 2014/34/EU Equipment explosive atmospheres (ATEX)
- 2014/68/EU Pressure Equipment (PED)
- 2014/29/EU Simple Pressure Vessels (SPV)
Note that the new Machinery Regulation 2023/1230 was published in 2023, becoming mandatory in January 2027. If your machinery product has not yet entered the EU Market, you should follow the Machinery Regulation rather than the Machinery Directive to avoid revising your CE Marking conformity assessment in 2027.
STANDARDS
There are potentially hundreds of standards that can apply, and it is the responsibility of the manufacturer or the importer of record to ensure that ALL of the applicable directives and standards have been applied to the product. A list of the current harmonized standards under each directive can be found by visiting the Harmonized Standards List of Directives and Subjects page. This page provides access to the text of the directives, as well as to lists of standards harmonized under each directive.
EU law also allows non-harmonized standards to declare conformity to the Essential Requirements of each directive. However, they provide a presumption of conformity when EN standards are used, making life much simpler from the conformity assessment perspective.
TECHNICAL FILES
Manufacturers are required to develop and maintain a Technical File for each product. The file must be maintained for ten years following the last date of manufacture and available in Europe through an organization located within the EU. This organization could be a branch office or an Authorized Representative.
Technical Files are confidential and need not be supplied to customers.
DECLARATIONS OF CONFORMITY
A Declaration of Conformity must accompany every product. This legal document should follow a common format and include the manufacturer’s name, trademark, and contact information, along with a list of the directives and standards used in the product’s assessment and information on any Notified Body(ies) involved in the conformity assessment of the product. Each Directive will lay out the requirements for marking and the Declaration’s content in the Annexes to the Directive.
Manufacturers’ Declarations should generally follow the requirements found in EN ISO/IEC 17050–1 and EN ISO/IEC 17050–2.
To understand Declarations more deeply, read this article on our blog.
