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Mechanical engineering

Directive 94/9/EC: Guidelines on the application


7.1. General

As a general rule, 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 has to be considered as a new product. If the answer to either of these questions is "yes", then Directive 94/9/EC fully applies. In all other cases the Directive 94/9/EC 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 94/9/EC is potentially applicable. Products not subject to Directive 94/9/EC are therefore excluded from these discussions.
  • The application of Directive 94/9/EC to an "as new" product is without any prejudice to intellectual property legislation.

With regard to the information to be provided for repair of equipment, see § 10.1.3 "Documents accompanying the product".

7.2. Definitions

Used product and second hand product: a product which has been placed on the EU market prior to the coming into force of Directive 94/9/EC and put into service on the EU territory. This product was in compliance with the then applicable legislation: national or EU, depending on the date. The ATEX Directive 94/9/EC does not apply.

Used products that were on the market and used in the EU before the date of entry into force of Directive 94/9/EC 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 EU based on Articles 28/30 of the EC Treaty 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 30 June 2003 for the purpose of distribution and/or use in the EU Directive 94/9/EC shall apply.

7.3. 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 94/9/EC does not apply.

7.4. Reconfigured products

Reconfigured products 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 94/9/EC does not apply.

7.5. Substantially modified products

In general, the relevant text of the "Guide to the Implementation of Directives Based on New Approach and Global Approach" (Blue Guide), chapter 2.1. "Products submitted to Directives" applies. In the sense of Directive 94/9/EC it is any modification affecting one or more of the health and safety characteristics covered by EHSRs (e.g. temperature) or the integrity of a type protection. In this case Directive 94/9/EC has to be applied. This does not preclude the application of other relevant Directives.

The general principle is that Directive 94/9/EC 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.

7.6. 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 the ATEX Directive 94/9/EC 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.

7.7. 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. A typical repair operation would be replacement by a spare part.

The manufacturer of the spare part is normally not required to comply with Directive 94/9/EC unless the spare part represents an equipment or component as defined by the Directive. If so, all obligations laid down in the Directive have to be fulfilled.

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 94/9/EC as the repaired product is not then placed on the market and put into service.

[1] The application of the ATEX Directive to "as-new equipment" is without any prejudice to intellectual property legislation. See Directive 89/104/EEC relating to the marks and the decision of the European Court of 11th July 1996, C427/93, 429/93, 436/93 Bristol Meyer Squibb.

[2] See Directive 89/104EEC relating to the marks and the decision of the European Court of Justice of 11 July 1996 in Joined Gases C-427/93 and C-436/93 Bristol Meyer Squibb.

[3] Both terms, reconditioned / refurbished, as well as reconditioning / refurbishment are used interchangeably in this chapter.

[4] This can involve a modification of the electrostatic characteristics. The use of different materials or different external dimensions of the product might adversely change its ATEX performances. For example, a plastic enclosure may provide much lower electrostatic protection than a metallic enclosure.


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