7.4.1 市場監視活動

Market surveillance authorities have to perform appropriate checks on an adequate scale of products made available online and offline (Article 11(1)(a) and 11(3) of Regulation (EU) 2019/1020). For market surveillance to be efficient, a risk-based approach has to be followed (Article 11(3) of Regulation (EU) 2019/1020). Resources should be concentrated where risks are likely to be higher or non-compliance more frequent. The risk-based approach should take into account aspects of products (level of potential hazards, non-compliance and associated risks; occurrence on the market), economic operators (activities and operations, past record of non-compliance) and information about both received from other actors (such as border control authorities, consumer complaints, media) as well as other sources that might indicate non-compliance such as incidents and accidents.

Market surveillance authorities do not necessarily check all the possible requirements on, or all properties of, a product. Usually, only some of these requirements and properties are selected for inspection.

Checks by market surveillance authorities may include inter alia:

—conducting online inspections;

—visiting commercial, industrial and storage premises;

—visiting, if appropriate, work places and other premises where products are put into service (291);requesting necessary information; and

—taking samples of products, and to subject them to examination and testing.

The first level of control comprises documentary and visual checks, for example regarding the CE marking and its affixing, the availability of the EU declaration of conformity, the information accompanying the product and the correct choice of conformity assessment procedures. In the case of online checks, the first level of control is checking the information available on the website where the product is offered for sale, potentially followed by requesting compliance documentation or acquiring the product for further inspection.

More in-depth checks may, however, be necessary to verify the conformity of the product, for example regarding the correct application of the conformity assessment procedure, the compliance with the applicable essential requirements, and the contents of the EU declaration of conformity. Especially when there are sufficient reasons to believe that a product presents a risk, market surveillance authorities carry out an evaluation in relation to the product concerned covering the requirements of the relevant Union harmonisation legislation (292).

Where economic operators present test reports or conformity assessment certificates issued by an accredited conformity assessment body, market surveillance authorities have to take due account of such reports or certificates (Article 11(5) of Regulation (EU) 2019/1020). Voluntary initiatives, such as product certification or application of a quality management system, cannot be put on the same footing as market surveillance activities carried out by an authority. Still, they can contribute to the elimination of risks and non-compliances. However, market surveillance authorities must be impartial regarding all voluntary marks, labels and arrangements: these may only be taken into consideration, in a transparent and non-discriminatory way, for the risk and compliance assessment. Accordingly, products should not be excluded from market surveillance operations even if they have been subject to voluntary certification or other voluntary initiatives.

Union harmonisation legislation provides for two different tools that enable market surveillance authorities to receive information on the product: the EU declaration of conformity and the technical documentation. These must be made available by the manufacturer, the authorised representative established within the Union or under certain circumstances by the importer or the fulfilment service provider established within the Union (293).

Other natural or legal persons, such as distributors are in principle not obliged to make these available (294). However, they are expected to assist the market surveillance authority in obtaining them. Further, the market surveillance authority may request the notified body to provide information on the conduct of conformity assessment for the product in question.

The EU declaration of conformity must be made available to the market surveillance authority without delay upon request (295). It shall accompany the product where so required by specific Union harmonisation legislation.

The technical documentation must be made available to the market surveillance authority within a reasonable period of time, in response to a reasoned request (Article R2(9) of Annex I to Decision No 768/2008). The authority cannot request it systematically. In general, it can be requested during checks made for market surveillance purposes, or when there are grounds for concern that a product does not offer the level of protection required in all respects.

More detailed information (for example certificates and decisions from the notified body) can, nevertheless, be requested in cases of doubt about the conformity of the product to the applicable Union harmonisation legislation (Article R2(9) of Annex I to Decision No 768/2008). The full technical documentation should be requested only where clearly necessary, and not, for example, when only a detail has to be checked.

This request has to be evaluated in accordance with the principle of proportionality and, thus, taking into account the need to ensure the health and safety of persons or other public interests foreseen in the applicable Union harmonisation legislation, as well as to protect the economic operators from unnecessary burden. Furthermore, failure to present the documentation in response to a reasoned request by a national market surveillance authority, within an acceptable timeframe, is a non-compliance and may constitute sufficient grounds for doubting the conformity of the product with the essential requirements of the applicable Union harmonisation legislation.

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. If the market surveillance authority considers a translation necessary, it must clearly indicate the part of the documentation to be translated and allow reasonable time for this to take place. No further conditions may be imposed on the translation, such as a requirement of a translator accredited or recognised by the public authorities.

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

It must be possible to make the technical documentation available in the Union. However, it does not need to be kept inside the Union, unless otherwise provided for in the applicable Union harmonisation legislation. The requirement for making it available does not mean that the economic operator who carries this obligation has to store it itself (296), as long as he is capable of presenting it on request from the national authority. Further, the technical documentation can be kept and sent to market surveillance authorities in paper or electronic form, which allows it to be made available within a period of time commensurate with the risk or non-compliance in question. Member States must ensure that everyone receiving information about the contents of the technical documentation during market surveillance activities is bound to confidentiality according to principles laid down in the national legislation.