Regulation (EU) 2016/424 of the European Parliament and of the CouncilShow full title

ANNEX VI CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3.1 and 4, and ensures and declares on his sole responsibility that the subsystem or safety component concerned, which has been subject to the provisions of point 3, is in conformity with the requirements of this Regulation that apply to it.

2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystem or safety component with the applicable requirements of this Regulation.

3. Verification

3.1. The manufacturer shall lodge an application for unit verification of a subsystem or a safety component with the notified body of his choice.

The application shall include:

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)

a written declaration that the same application has not been lodged with any other notified body;

(c)

the technical documentation for the subsystem or the safety component according to Annex VIII;

(d)

details of the premises where the subsystem or the safety component can be examined.

3.2. The notified body shall examine the technical documentation for the subsystem or the safety component and shall carry out the appropriate examinations and tests set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the subsystem or the safety component with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved subsystem or safety component, or have it affixed under its responsibility.

If the notified body refuses to issue a certificate of conformity, it shall state in detail the reasons for the refusal and indicate the necessary corrective measures to be taken.

When the manufacturer reapplies for unit verification of the subsystem or the safety component concerned, he shall apply to the same notified body.

On request, the notified body shall provide the Commission and the Member States with a copy of the certificate of conformity.

The manufacturer shall keep the technical documentation and the certificate of conformity at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market.

4. CE marking and EU declaration of conformity

4.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each subsystem or safety component that satisfies the applicable requirements of this Regulation.

4.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or the safety component for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

5. Authorised representative

The manufacturer's obligations set out in points 3.1 and 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.