We perform the entire CE conformity evaluation procedure for CE marking acc. to the required EU directive / EU regulation. Our qualified specialists are by your side assisting you in the process of CE marking, all the way until the required Declaration of Conformity or Declaration of Incorporation for incomplete machines is ready to sign.
- Implementing all relevant legal requirements reliably and securely (Ordinance on Product Safety, Produktsicherheitsgesetz ProdSG / EU Product Safety Regulation etc.)
- For own constructions, modifications, assembled systems, imported machines, used machines (if applicable)
Important Steps in the CE Conformity Evaluation Procedure for CE Marking
- Research of standards and directives (machinery directive / EU Machinery Regulation etc.)
- Risk assessment with risk analysis and the risk evaluation
- Measurement / inspection
- Documentation
- Technical documents
- Technical translation (At least in the EU countries, your product may not be put to the market unless it has instructions in the corresponding official language(s).)
- Communication with the authorities
- EC/EU Declaration of Conformity or Declaration of Incorporation ready to sign
CE Conformity Evaluation Procedure for CE Marking acc. to EU Machinery Directive 2006/42/EC
A manufacturer who wants to put his machine on the market in the European Economic Area EEA, that is within the EU or in Iceland, Liechtenstein, Norway and the associate states Switzerland and Turkey, must perform a CE conformity evaluation procedure acc. to the EU Machinery Directive 2006/42/EC. First the manufacturer must check whether the machine is covered by the EU Machinery Directive 2006/42/EC at all. Then the manufacturer must determine which conformity evaluation procedures acc. to EU Machinery Directive 2006/42/EC are possible and/or prescribed for the machine. In the course of the conformity evaluation procedure acc. to EU Machinery Directive 2006/42/EC, the manufacturer has to perform several steps. To research laws, standards and legal regulations, to determine whether and which harmonised standards to apply for the conformity evaluation procedure acc. to 2006/42/EC, to perform measurements and tests, to perform a risk assessment and ensure that the machine meets all safety and health protection requirements, to create the technical documentation, create the operating instructions for the customer, to issue the EU declaration of conformity and to finish the conformity evaluation procedure acc. to Machinery Direction 2006/42/EC by attaching the CE marking. If the manufacturer exports the machine, instructions for the customer in the language of the country where it is used must be provided with the machine.
We will gladly advise you whether and which conformity evaluation procedure acc. to EU Machinery Directive 2006/42/EC is required for your product.
And, of course, advise you on the EU Machinery Regulation, Regulation (EU) 2023/1230 on machinery, which replaces the Machinery Directive on January 20, 2027.
Call us, telephone +49 40 5238871-0, or send us a message.
Member states of the European Union (EU) and states of the European Economic Area (EEA)
Member States of the European Union are: Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, the Netherlands, Poland, Portugal, Rumania, Slovakia, Slovenia, Spain, Sweden.
The European Economic Area comprises the member states of the European Union as well as Iceland, Liechtenstein and Norway.
For the associate states Switzerland and Turkey, individual state agreements apply.
United Kingdom was EU member state until 31 January 2020. The CE marking for certain products is initially to continue to be recognized for an unlimited period (as of 01.11.2023), see our blog post Brexit in nice: CE remains.
Which technical documentation need to be present for the CE conformity evaluation procedure?
In order to perform the CE conformity evaluation procedure for the system, the technical documentation of the individual parts/components/machines must be available:
- a general description of the machine
- an assembly drawing of the machine and wiring diagrams of the control circuits
- descriptions and explanations that we need to understand the principle of the machine
- complete detail drawings, if applicable with calculations, test results, certificates, etc.
- the documents of the machine risk assessment
- the applied standards and other technical specifications
- all technical reports with the test results
- test reports and results of trials
- a copy of the operating instructions of the machine
- if applicable, the Declaration of Incorporation for incomplete machines and the assembly instructions for such incomplete machines
- if applicable, a copy of the EC Declaration of Conformity for other machines or products integrated into the machine
- a copy of the EU Declaration of Conformity
If the documents for individual parts/components/machines are not available, we will advise you on measures you will have to take.
For further information on the conformity evaluation procedures required by the individual directives, refer to EUR-Lex, the official site of the EU regarding EU law and other official documents.
