All products covered by a product directive must be CE marked before they can be marketed and put into use on the European market.
The CE marking ensures the free movement of the product throughout the European Economic Area (EEA), and with the marking the manufacturer or importer guarantees that the product complies with all the legal requirements of that Directive.
It does not appear from the CE marking, which product directives a product complies with – however, this appears from the accompanying declaration of conformity which may point to several different directives and harmonized standards.
For machines and machine systems, the requirements of Machinery Directive 2006/42/EC must be met.
Greater security for buyer and user
The CE mark does not only bring marketing advantages.
With the CE marking of the machine, you as the manufacturer show that you have designed a safe machine and that it complies with all relevant safety-related requirements in the directive and the harmonized standards, indicating state ‘state-of-art’ for safety in the EU. This allows the machine to be used immediately for the purpose for which it was designed - without danger to the end user.
If the machine is assembled with other machines, however, a risk assessment of the assembly must be carried out, and there may be a requirement for a CE marking of the entire machine system.
The CE marking is relevant for:
- Production of new machines, lifting gear etc.
- Manufacturing of machines for own use and testing
- Assembly of machines
- Import from non-EU countries
- significant change/reconstruction.
Start the CE marking process well in advance
It is important that you as a manufacturer uncover relevant directives as well as the requirements of the standards before you start designing and constructing a machine. The alternative is expensive, as it can lead to e.g. reconstruction, expensive safety solutions or restrictions on the use of the machine.
The use of - and restrictions on the use of - the machine must therefore be defined before the safety requirements can be identified and the risk assessment prepared. The same conditions must later appear in the operating instructions.
Particularly dangerous machines, which are listed in Annex IV of the Machinery Directive, may require special approval procedures.
How can the Danish Technological Institute help you?
As a notified body in Denmark (no. 396), the Danish Technological Institute has the necessary competencies within the Machinery, Pressure Equipment and ATEX directives, and we can offer to facilitate the process in all phases of the development.
Among other things, we can help with:
- Uncovering relevant directives and harmonized standards
- Examination of the safety requirements and solutions
- Preparation of risk assessments in accordance with the requirements of the directives
- Ensuring that the contents of the Technical Dossier are adequate
- Performing structural calculations
- Preparation of instructions for use, declaration of conformity and CE mark
Our extensive experience and competencies within CE marking guarantee a high level, and we ensure that the relevant requirements are complied with, and that the machine complies with the applicable guidelines.
We also offer
In addition to CE marking, the Danish Technological Institute also offers type examination of particularly dangerous Annex IV machines.
Contact us if you want help with the CE marking or if you have questions about the above.