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1. Manufacturers shall ensure that when their vehicles, systems, components or separate technical units are placed on the market or are entering into service, they are manufactured and approved in accordance with the requirements set out in this Regulation and the delegated and implementing acts adopted pursuant to this Regulation.

2. In the case of multi-stage type-approval, each manufacturer shall be responsible for the approval and conformity of production of the systems, components or separate technical units added at the stage of vehicle completion handled by the manufacturer. Any manufacturer who modifies components or systems already approved at earlier stages shall be responsible for the approval and conformity of production of the modified components and systems.

3. Manufacturers who modify the incomplete vehicle in such a manner that it qualifies as a different category of vehicle, with the consequence that the legal requirements already assessed in a previous stage of approval have changed, shall also be responsible for compliance with the requirements applicable to the category of vehicles for which the modified vehicle qualifies.

4. For the purposes of approval of vehicles, systems, components or separate technical units covered by this Regulation, manufacturers established outside the Union shall appoint a single representative established within the Union to represent them before the approval authority.

5. Manufacturers established outside the Union shall furthermore appoint a single representative established within the Union for the purposes of market surveillance, which may be the representative referred to in paragraph 4 or an additional representative.

6. Manufacturers shall be responsible to the approval authority for all aspects of the approval process and for ensuring conformity of production, whether or not they are directly involved in all stages of the construction of a vehicle, system, component or separate technical unit.

7. In accordance with this Regulation and the delegated and implementing acts adopted pursuant to this Regulation, manufacturers shall ensure that procedures are in place for series production to remain in conformity with the approved type. Changes in design of a vehicle, system, component or separate technical unit or characteristics and changes in the requirements to which a vehicle, system, component or separate technical unit is declared to conform shall be taken into account in accordance with Chapter VI.

8. In addition to the statutory marking and type-approval marks fixed to their vehicles, components or separate technical units in accordance with Article 34, manufacturers shall indicate their name, registered trade name or registered trade mark and the address in the Union at which they can be contacted on their vehicles, components or separate technical units made available on the market or, where that is not possible, on the packaging or in a document accompanying the component or separate technical unit.

9. Manufacturers shall ensure that, while a vehicle, system, component or separate technical unit is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in this Regulation.