3.1 製造業者

The manufacturer is any natural or legal person who is responsible for designing or manufacturing a product and places it on the market under his own name or trademark (105). The definition contains two cumulative conditions: the person has to manufacture (or have a product manufactured) and to market the product under his own name or trademark. So, if the product is marketed under another person’s name or trademark, this person will be considered as the manufacturer.

The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes or labels ready-made products and places them on the market under his own name or trademark. Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential or other legal requirements will become applicable, or substantially modifies or re-builds a product (thus creating a new product), with a view to placing it on the market or for putting it into service, in those cases where the Union harmonisation legislation applicable to the product includes putting into service in its scope (106).

The manufacturer may design and manufacture the product himself. As an alternative, he may have it designed, manufactured, assembled, packed, processed or labelled with a view to placing it on the market under his own name or trademark, and thus presenting himself as a manufacturer (107). Where subcontracting takes place, the manufacturer must retain the overall control for the product and ensure that he receives all the information that is necessary to fulfil his responsibilities according to the relevant Union harmonisation act. The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities, for example to an authorised representative, a distributor, a user or a subcontractor.

The manufacturer has ultimate responsibility for the conformity of the product to the applicable Union harmonisation legislation, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market under his name or trademark.

Thus, when a product is transferred to a manufacturer for further measures such as assembling, packaging, processing or labelling, when placing the product on the market, he has the sole and ultimate responsibility for ensuring the conformity of the product to the applicable legislation, and must be able to do so.

The manufacturer is responsible for designing and manufacturing the product in accordance with essential or other legal requirements laid down by the relevant Union harmonisation legislation and for carrying out conformity assessment in accordance with the procedure(s) laid down by the Union harmonisation legislation (108).

The manufacturer is obliged to understand both the design and construction of the product to be able to take the responsibility for the product being in compliance with all provisions of the relevant Union harmonisation legislation. This applies equally to situations where the manufacturer designs, manufactures, packs and labels the product himself, as to situations where some or all of these operations are carried out by a subcontractor. The manufacturer needs to have the relevant information to demonstrate compliance of the product at its disposal.

In this respect, the economic operator that places the product on the market under its name or trademark becomes automatically the manufacturer for the purposes of Union harmonisation legislation. Therefore he takes the entire responsibility for the conformity assessment (design and production) of the product, even if this has been actually done by somebody else. Furthermore he must be in the possession of all documentation (such as the technical documentation including any relevant test reports) and certificates necessary to demonstrate the conformity of the product, but these do not need to be under his name. In such cases, it must be clear that the documentation and certificates demonstrate compliance of the specific product placed on the market.

The Lifts Directive 2014/33/EU defines the installer of a lift as ‘the natural or legal person who takes responsibility for the design, manufacture, installation and placing on the market of the lift’. Hence, the installer is a person who assumes responsibilities which in the context of other Union harmonisation legislation are typically assigned to the manufacturer.

Union harmonisation legislation does not require the manufacturer to be established in the European Union. Thus, when placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State.

As a general rule, when placing a product on the market the manufacturer must take all measures necessary to ensure that the manufacturing process assures compliance of the products (109) and in particular:

1.carry out the applicable conformity assessment or have it carried out, in accordance with the procedure(s) laid down by the relevant Union harmonisation legislation. Depending on the Union harmonisation act, the manufacturer may be required to submit the product to a third party (usually a notified body) to have the conformity assessment carried out, or to have a quality system approved by a notified body. In any case, the manufacturer bears full responsibility for product conformity;

2.draw up the required technical documentation;

3.draw up the EU Declaration of Conformity;

4.accompany the product with instructions and safety information (110) (111) as required by the applicable Union harmonisation legislation (112), in a language easily understood by consumers and other end-users, as determined by the Member State concerned (113). Unless otherwise specified in specific legislation, instructions and safety information need to be provided (114), whether the product is intended for consumers or other end-users. This should include all the necessary information for the safe use of the product, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product. Instructions for assembly or installation should include the inventory parts and special skills or tools. Instructions on operation should include information for restriction of use, need for personal protective equipment, maintenance and cleaning or repair. It is for the manufacturer to determine the relevant information which should be included in the instructions and safety information for a particular product. Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product. Furthermore, a tool designed and intended to be used by professionals only might also be used by non-professionals, the design and instructions accompanied must take this possibility into account. Instructions and safety information must be clear, understandable and intelligible;

5.satisfy the following traceability requirements:

—Keep the technical documentation and the EU Declaration of Conformity for 10 years after the product has been placed on the market (115) or for the period specified in the relevant Union harmonisation act.

—Ensure that the product bears a type, batch or serial number or other element allowing its identification.

—Indicate the following elements: his (1) name, registered trade name or registered trade mark and (2) a single contact postal address on the product (116) or when not possible because of the size or physical characteristics of the products (117), on its packaging (118) and/or on the accompanying documentation (119) (120) (121). The single contact point may not necessarily be located in the Member State where the product is made available on the market.

6.affix the conformity marking (CE marking and where relevant other markings (122)) to the product in accordance with the applicable legislation;

7.ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of a product is declared must be adequately taken into account. The kind of action to be taken by the manufacturer depends on the nature of changes in the harmonised standards or other technical specifications, in particular whether these changes are material with regard to the coverage of the essential or other legal requirements and whether they concern the product in question. This might require for instance to update the EU Declaration of Conformity, change the product design, contact the notified body, (123) etc.;

8.where relevant, certify the product and/or the quality system.

Under certain Union harmonisation acts, the manufacturer may be required to perform sample testing at the end of the production chain or of already marketed products in view of offering additional protection to consumers or other end-users (124) (125).

Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Union harmonisation legislation must immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where manufacturers have reason to believe that the product presents a risk to health, safety, the environment or any other public interest protected by the applicable legislation (126), they must immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the noncompliance and of any corrective measures taken. The Commission provides an IT tool, the Product Safety Business Alert Gateway’ to facilitate practical aspects of this obligation (127).

Upon a reasoned request (128), the manufacturer has to provide the competent national authority with all the information and documentation necessary to demonstrate the conformity of a product, in a language which can be easily understood by that authority. This would include, for example, the declaration of conformity, the relevant part of the technical documentation, or certificates issued by Notified Bodies. If agreed with market surveillance authorities, this information may be transmitted electronically. Manufacturers must cooperate with the authority, at its request, on any action taken to eliminate or mitigate the risks posed by products which they have placed on the market. Manufacturers must on request of market surveillance authorities identify any economic operator to whom they have supplied a product. They must be able to present this information for a period of 10 years after they have supplied the product.

The idea is that the national authority might accept a language they understand and which is different from the national language(s). The language chosen is subject to negotiation with the authority and could be a third language, if accepted by the authority.

In the case of a reasoned request it is sufficient for the manufacturer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation. The request may indicate a deadline for the receipt of the requested documents, depending on the Union harmonisation legislation the product is subject to. A shorter deadline can be fixed if the national authority justifies the urgency on the basis of an immediate serious risk.

If the Union harmonisation legislation covers putting into service, the natural or legal person who puts the product into service has the same responsibilities as a manufacturer who places a product on the market. He must ensure that the product complies with the Union harmonisation legislation, and that the appropriate conformity assessment procedure has been carried out (129).

Furthermore, a person who places on the Union market second-hand products from a third country, or any product not designed or manufactured for the Union market, must assume the role of the manufacturer.

Finally, if an importer or distributor modifies a product to the extent that the compliance with the applicable requirements may be affected or supplies it under his name or trademark, then he is to be considered the manufacturer and must undertake all the obligations incumbent on the manufacturer (130). Accordingly, he must ensure that the product complies with the applicable Union harmonisation legislation and that the appropriate conformity assessment procedure has been carried out (131).