Module B

Assessment Module B – EC-type examination

EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical
design of a product and verifies and attests that the technical design of the product meets the requirements of the
legislative instrument that apply to it.

The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.

The application shall include:

• the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address
• a written declaration that the same application has not been lodged with any other notified body,
• the technical documentation.

The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of the legislative instrument and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain, wherever applicable, at least the following elements:

• a general description of the product,
• conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
• descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,
• a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
• results of design calculations made, examinations carried out, etc., and
• test reports.

Be aware that assessment module B never stands alone and requires second assessment module F or D!