Within the scope of the New Approach Directives published in the European Union countries, CE marking is a must on the products produced in the European Union countries or produced outside and imported to these countries. In parallel with this, in our country, Yönet CE ”Marking Regulation has been published in order to regulate the principles regarding the use of CE marking with conformity assessment modules regulating the methods of this application. In the annexes of this regulation, conformity assessment methods are described in modules (Annex 3).

The EC type-examination is described in this appendix under Module B. Accordingly, in EC type-examination, a conformity assessment process is the process of verifying and confirming that the notified body examines the technical design of the product and that this design complies with the relevant criteria of the technical regulations.

EC type-examination under this Article shall be carried out in accordance with any of the following methods:

  • Examination of the sample representing the finished state of the product intended to be produced
  • Examining the technical dossier and supporting evidence, evaluating the technical design of the product is sufficient and examining one or more important parts of the product sample intended to be produced
  • Evaluation of the technical design of the product is sufficient by examining the technical file and supporting evidence without sample examination

Producer companies may have the EC type-examination carried out by a notified body designated by them. The following information and documents must be completed at the time of application:

  • Name and address of the manufacturer (or authorized representative)
  • A written statement explaining that the same application has not been filed with another notified body
  • Technical file.

The technical dossier is sufficient to ensure that the product complies with the relevant criteria and includes adequate analysis and assessment of risks. In this dossier, a general description of the product, design and production drawings, diagrams of components, parts and circuits, a description of the product operation, a list of harmonized national standards applied, solutions adopted to meet the basic requirements if standards are not applied, evidence supporting the adequacy of samples and technical design solutions representing the product ( laboratory test results).

The notified body reviews the technical dossier and the supporting evidence in it to assess the adequacy of the technical design of the product. It also confirms that the sample has been produced in accordance with the technical dossier and that harmonized national standards have been followed, and that the specified solutions have been followed to meet the basic requirements if the standards have not been complied with. Applies appropriate tests and tests for conformity assessment when necessary. At the end, he prepares an evaluation report.

If the product meets the criteria set out in the relevant regulations, the notified body shall issue an EC type-examination certificate and deliver it to the manufacturer.

The EC type-examination certificate includes the name and address of the manufacturer, the results of the examination, the conditions for the validity of the certificate and other necessary information. This document and its annexes contain any information that may allow the assessment of the conformity of the products to the type being examined. If, after inspection, the product type does not comply with the relevant technical regulations, the notified body shall not issue an EC type-examination certificate and shall notify the manufacturer.

Manufacturers must keep the EC type-examination certificate and its annexes together with the technical dossier for ten years from the date the product is placed on the market.

In short, the Module B system is a CE mark, conformity assessment procedure and requires type approval. Producer companies cannot go beyond this approval in their production activities. Essentially, the approval certificate received under Module B relates to the design phase of the product. It is used with modules that cover the manufacturing processes of the product, such as Module E or Module D.

TÜRCERT also provides EC type examination services within the scope of numerous laboratory services. Thanks to these services, enterprises receive more efficient, high-performance and high-quality services and provide safe, fast and uninterrupted service to their customers.

In addition to EC type examination services provided within the scope of laboratory services, TÜRCERT also provides other services.