Conformity evaluation procedure

Conformity evaluation procedure

Conformity evaluation procedure

We perform the entire conformity evaluation procedure for you, acc. to the required EU directive.

  • Research of standards and directives (machinery directive etc.)
  • Risk assessment
  • 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

Conformity evaluation procedure 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 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. Call us or send us a message.

Note: 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, and the United Kingdom.

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.

 

Which technical documentation need to be present for the conformity evaluation procedure?

In order to perform the 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.

Good to know: Survey and application of EU legislation

(acc. to EU Commission, ec.europa.eu, Dec. 2014)

EU legislation is divided into primary law and secondary law directives.

Primary law: Treaties forming the base for all EU measures.

Secondary law: Regulations, Directives and Enactments on the basis of the principles and aims in the treaties.

The member states must apply the EU Treaties and relevant legislation correctly and within the time limit, the Commission supervises the application of Union Law.

The Commission shall interfere if a member state

  • does not put EU Directives into national law, or does not inform about measures taken, or
  • is suspected to breach EU Legislation.

The Commission shall try to find a solution, else

  • formal treaty violation proceedings, or
  • action at the European court of Justice shall be considered.

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