§33 中古品、修理品又は改造品及び交換部品

Generally, manufacturers need to consider whether the product is being placed onto the EU market or taken into service for the first time, or if the modifications are such that the intention or the result is to place a product onto the market, which must be considered as a new product. If the answer to either of these questions is "yes", then Directive 2014/34/EU fully applies. In all other cases the Directive 2014/34/EU does not apply, and the responsible person will have to ensure that any other relevant national or EU legislation are considered as appropriate.

Within this context two points should be made:

In the following paragraphs, these Guidelines refer only to products for which Directive 2014/34/EU is potentially applicable. Products not subject to Directive 2014/34/EU are therefore excluded from these discussions.

The application of Directive 2014/34/EU to an "as new" product is without any prejudice to intellectual property legislation.

Regarding the information to be provided for repair of equipment, see section § 151 on instructions.

Used products and second hand products

In general terms, a "used product" is a product which has already been used; in this section, "used product" is intended as a product which has been placed on the EU market prior to the coming into force of Directive 2014/34/EU and put into service on the EU territory. This product was in compliance with the applicable legislation: national or EU (as Directive 94/9/EC, applicable from 1 July 2003 to 19 April 2016), depending on the date. In this case Directive 2014/34/EU does not apply.

Used products that were on the market and used in the EU before the date of entry into force of Directive 2014/34/EU are not covered by it. These products have been marketed and used in accordance with the regulations in force at that time. They circulate in the European Union based, among others, on Articles 28 and 30 of the Treaty on the Functioning of the European Union (TFEU) concerning free movement of goods, unless they are modified so that health and safety characteristics have been affected.

For used products imported from a non-EU country and made available for the first time in the EU after 20 April 2016 for the purpose of distribution and/or use in the EU, Directive 2014/34/EU shall apply.

Reconditioned (or refurbished) products

These are used products which were on the market and used in the EU but whose performance has changed over time (due to ageing, obsolescence, etc.), and which have been modified so as to be restored. The case of products whose external appearance has been modified and improved by a cosmetic or aesthetic operation after they have been placed on the market and put into service is a particular form of refurbishment aimed at restoring the external appearance of the product. If this occurs with no substantial modification Directive 2014/34/EU does not apply.

Reconfigured products

These are used products which were on the market and used in the EU but whose configuration has been modified, by the addition (upgrading) or the removal (downgrading) of one or more parts (components, sub-assemblies such as plug-in cards or modules, etc.). If this occurs with no substantial modification Directive 2014/34/EU does not apply.

Substantially modified products

In the sense of Directive 2014/34/EU, a substantial modification is any modification to a product affecting one or more of the health and safety characteristics covered by essential health and safety requirements (e.g. temperature) or the integrity of a type protection. In this case Directive 2014/34/EU must be applied. Of course, this does not preclude the application of other relevant EU legislation, if it is the case.

According to the above, the general principle is that Directive 2014/34/EU re-applies to a modified product where the modification is considered to be substantial and if it is intended to be placed again on the EU market for distribution and/or use or to be used for own purposes.

Repaired products

These are products whose functionality has been restored following a defect without adding new features or any other modification. As this occurs after the product has been placed on the market and the product is not to be sold as a new product, in this case Directive 2014/34/EU does not apply.

This does not preclude that national regulations of the Member States on the working environment may require some kind of assessment of the repaired product as well.

Spare parts

These are items intended to replace a defective or worn-out part of a product previously placed and put into service on the EU market. These items are either identical, or at least similar, to the original part (modifications may have taken place due to technical progress, or discontinued production of the old part). A typical repair operation would be replacement by a spare part. Since the spare parts are primarily intended for maintenance of a finished product, which has been placed on the market, they are not required to comply with Directive 2014/34/EU.

If the manufacturer of the original spare part offers a new, different one in its place (due to technical progress, discontinued production of the old part, etc.), and it is used for the repair, the repaired product (as long as no substantial modification of the repaired product takes place) does not need to be brought into conformity at this time with Directive 2014/34/EU as the repaired product is not then placed on the market and put into service.