2.1 製品の範囲

Union harmonisation legislation applies to products which are intended to be placed (and/or put into service (27)) on the market (28). Furthermore, Union harmonisation legislation applies when the product is placed on the market (or put into service) and to any subsequent making available until the product reaches the end-user (29) (30). A product still in the distribution chain falls under the obligations of the Union harmonisation legislation as long as it is a new product. (31) Once it reaches the end-user it is no longer considered a new product and the Union harmonisation legislation no longer applies. This is without prejudice to the level of safety or other public interest protection that a product must offer when used as intended in relation to the applicable Union harmonisation legislation at the time it was placed on the market, or to any market surveillance measure that may be taken in relation to products which have already been made available to an end user and present a risk (e.g. recalls).

The end-user is not one of the economic operators who bear responsibilities under Union harmonisation legislation i.e. any operation or transaction by the end-user involving the product is not subject to Union harmonisation legislation. However, such an operation or transaction might fall under another regulatory regime, in particular at national level.

The product must comply with the legal requirements that were in place at the time of its placing on the market (or putting into service).

Union harmonisation legislation applies to all forms of supply, including distance selling and selling through electronic means. Hence, regardless of the selling technique, products intended to be made available on the Union market must be in conformity with the applicable legislation.

A product intended to be placed on the Union market, offered in a catalogue or by means of electronic commerce, has to comply with Union harmonisation legislation when the catalogue or website targets its offer to the Union market and includes an ordering and shipping system (32). Products offered for sale online or through other means of distance sales are deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale is considered to be targeted at end users in the Union if an economic operator directs, by any means, its activities to a Member State. A case-by-case analysis should be carried out in order to establish whether an offer is targeted at end users in the Union. (33)

The Union harmonisation legislation applies to newly manufactured products but also to used and second-hand products, including products resulting from the preparation for re-use of electrical or electronic waste, imported from a third country when they enter the Union market for the first time (34) (35). This applies even to used and second-hand products imported from a third country that were manufactured before the legislation became applicable.

Used and second-hand products which are on the Union market, and which are supplied to consumers are covered by the GPSD (Article 2(a) of the GPSD) when they are supplied or made available, whether for consideration or not, in the course of a commercial activity, unless the second-hand products are supplied as antiques or as products to be repaired or reconditioned prior to being used, and the supplier has clearly informed the person to whom he supplies the product to that effect. Under the GPSD, producers must ensure that they only place safe products on the market.

Union harmonisation legislation applies to finished products, as defined by the scope of each specific Union harmonisation legislation. Yet, the concept of product varies between different pieces of Union harmonisation legislation. The objects covered by legislation are referred to, for instance, as products, equipment, apparatus, devices, appliances, instruments, materials, assemblies, components or safety components, units, fittings, accessories, systems or partly completed machinery. Thus, within the terms of a specific Union harmonisation act, components, spare parts or sub-assemblies may be regarded as finished products and their end-use may be the assembly or incorporation into a finished product. If this is the case, such products must comply with the applicable legislation at the time they are placed on the Union market (and/or put into service), that is, when they are first supplied for distribution, consumption or use on the Union market. When a finished product incorporating another product is placed on the Union market, the manufacturer is responsible for the compliance of the complete product with the applicable legislation. The manufacturer of this finished product can rely on the conformity assessment of the integrated product to build the Declaration of Conformity, conformity assessment and documentation of the product.

Unless there are more specific provisions, Union harmonisation legislation applies to the products it defines within its scope, irrespective of whether they are being supplied ready for use or intended for installation.

It is the responsibility of the manufacturer to verify whether or not the product is within the scope of a given piece of Union harmonisation legislation (36) (37).

A combination of products and parts, which each comply with applicable legislation, does not always constitute a finished product that has to comply itself as a whole with a given Union harmonisation legislation. However, in some cases, a combination of different products and parts designed or put together by the same person is considered as one finished product which has to comply with the legislation as such. In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it complies with the provisions of the laws concerned, and for fulfilling all the requirements of the legislation in relation to the assembly, the EU Declaration of Conformity and CE marking. The fact that components or parts are CE marked does not automatically guarantee that the finished product also complies. Manufacturers must choose components and parts in such a way that the finished product itself complies. The manufacturer must verify on a case-by-case basis whether a combination of products and parts has to be considered as one finished product in relation with the scope of the relevant legislation.

If there are two or more finished products made available in the same package which do not constitute a single finished product but which are intended to function together, the manufacturer marketing the combination must address the risks of the products included in the package when used in operation with each other.

After they are placed on the market, products may be subject to life extension processes. While some of these processes intend to maintain or restore the product to its original condition, others imply that substantial modifications are made to the product.

A product, which has been subject to important changes or overhaul after it has been put into service must be considered as a new product if: i) its original performance, purpose or type is modified, without this being foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased in relation to the relevant Union harmonisation legislation; and iii) the product is made available (or put into service if the applicable legislation also covers putting into service within its scope). This has to be assessed on a case-by-case basis and, in particular, in view of the objective of the legislation and the type of products covered by the legislation in question.

Where a modified product (38) is considered as a new product, it must comply with the provisions of the applicable legislation when it is made available or put into service. This has to be verified by applying the appropriate conformity assessment procedure laid down by the legislation in question. In particular, if the risk assessment leads to the conclusion that the modified product has to be considered as a new product, then the compliance of the modified product with the applicable essential requirements has to be reassessed and the person carrying out the substantial modification has to fulfil the same requirements as an original manufacturer, for example preparation of the technical documentation, drawing up a EU declaration of conformity and affixing the CE marking on the product.

In any case, a modified product sold under the name or trademark of a natural or legal person different from the original manufacturer, should be considered as new and subject to Union harmonisation legislation. The person who carries out important changes to the product carries the responsibility for verifying whether or not it should be considered as a new product in relation to the relevant Union harmonisation legislation. If the product is to be considered as new, this person becomes the manufacturer with the corresponding obligations. Furthermore, in the case the conclusion is that it is a new product, the product has to undergo a full conformity assessment before it is made available on the market and the new manufacture’s name and contact address must be indicated on the product. However, the technical documentation has to be updated in as much as the modification has an impact on the requirements of the applicable legislation. It is not necessary to repeat tests and produce new documentation in relation to aspects not impacted by the modification. It is up to the natural or legal person who carries out changes or has changes carried out to the product to demonstrate that not all elements of the technical documentation need to be updated. The natural or legal person who carries out changes or has changes carried out to the product shall be responsible for the conformity of the modified product and draw a declaration of conformity, even if they use existing tests and technical documentation.

Products which have been repaired (for example following a defect), without being considered as new products do not need to undergo conformity assessment again, whether or not the original product was placed on the market before or after the legislation entered into force. This applies even if the product has been temporarily exported to a third county for the repair operations. For certain products, manufacturers are required to provide spare parts to other third parties to perform the repairs, and for a certain minimum period of time (39). Such repair operations are often carried out by replacing a defective or worn item by a spare part, which is either identical, or at least similar, to the original part (for example modifications may have taken place due to technical progress, or discontinued production of the old part), by exchanging cards, components or sub-assemblies. If the original performance of a product is modified (within the intended use, range of performance and maintenance originally conceived at the design stage) because the spare-parts used for its repair perform better due to technical progress, this product is not to be considered as new according to Union harmonisation legislation. Thus, maintenance operations are basically excluded from the scope of the Union harmonisation legislation. However, at the design stage of the product the intended use and maintenance must be taken into account (40).

Software is today essential for the functioning of products. Under the medical device and in vitro medical devices legislation, software in its own right presenting certain features is considered as a medical device or an in vitro diagnostic medical device (41). Certain pieces of Union harmonisation legislation refer explicitly to the software integrated in the product (42).

As part of the initial risk assessment, the manufacturer of the final product has obligations to foresee the risks of software integrated in that product at the time of its placing on the market. The concept of product safety encompasses protection against all kinds of risks arising from the product, including not only mechanical, chemical, electrical risks but also the safety-related aspects of cyber risks and risks related to the loss of connectivity of devices.

Software updates or repairs could be assimilated to maintenance operations provided that they do not modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected. As is the case for physical repairs or modifications, a product should be considered as substantially modified by a software change where: i) the software update modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) the product is made available (or put into service where this is covered by the specific Union harmonisation legislation).