In brief
Conformity assessment is the procedure used to demonstrate that a product meets the requirements of the EU legislation applicable to it.
Contents
What is Conformity assessment?
Before a product covered by EU harmonisation legislation is placed on the market, the manufacturer must demonstrate its conformity with the applicable requirements. This is done in the conformity assessment. Its result is the technical documentation, the EU declaration of conformity and, as a rule, the CE marking. Responsibility always remains with the manufacturer, even when third parties are involved.
The possible procedures are described in modules based on Decision No 768/2008/EC. Module A is internal production control without an external body; other modules provide for type examination, monitoring of production or full quality assurance with the involvement of a notified body. Which modules are permissible is laid down by the respective directive or regulation depending on the risk, for example the Low Voltage Directive, the Pressure Equipment Directive or the Machinery Regulation. Notified bodies are listed in a public database of the European Commission.
For procurement, it is important that the declaration of conformity matches the product supplied and names the relevant legislation. In the case of conversions, the party carrying out the conversion may itself be required to carry out a new assessment. The respective legal acts are authoritative; this entry does not constitute legal advice.
In practice: maintenance and procurement
For spare parts subject to CE marking, check whether the manufacturer, type and directives named in the declaration of conformity match the part supplied. If a notified body is involved, its identification number next to the CE mark can be verified in the EU’s public database.
Synonyms and abbreviations: conformity assessment procedure · proof of conformity · Module A (internal production control) · CE conformity assessment
Frequently asked questions
Who carries out the conformity assessment?
Responsibility always lies with the manufacturer or, for products from non-EU countries without an EU manufacturer, possibly with the importer. For many lower-risk products, the manufacturer carries out the assessment itself. For higher risks, the applicable law requires the involvement of a notified body, which, for example, carries out a type examination or monitors the quality assurance system.
What is a notified body?
A notified body is an independent testing organisation that has been notified by a Member State for specific conformity assessment procedures. It receives a four-digit identification number, which is shown next to the CE mark when it is involved. Whether a body is competent for a particular directive and procedure can be checked in the European Commission’s public database.
What is the difference between conformity assessment and the declaration of conformity?
Conformity assessment is the procedure by which the manufacturer checks and demonstrates that its product meets the requirements. The EU declaration of conformity is the document with which, at the end of this procedure, it declares in a legally binding manner that the requirements are met. The declaration is therefore the result, and the assessment is the route to it.