3.6. Design examination

The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1. The application shall make it possible to understand the design, manufacture and operation of the subsystem or safety component, and to assess the conformity with the requirements of this Regulation that apply to it. It shall include: the name and address of the manufacturer; a written declaration that the same application has not been lodged with any other notified body; the technical documentation as described in Annex VIII. The notified body shall examine the application and, where the design meets the requirements of this Regulation that apply to the subsystem or safety component, it shall issue an EU design examination certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached. That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems or safety components with the examined design to be evaluated and to allow for in-service control, where applicable. Where the design does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval from the notified body that issued the EU design examination certificate in the form of an addition to the original EU design examination certificate. Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate. The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 30 years after the subsystem or safety component has been placed on the market.

← anx_VII__cpt_1__cpt_3__cpt_5__text_4 · All articles · 3.6.1. →

Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.