Annex XI 地理的適用

Application in non-EU States, countries & territories

The geographical application of new approach directives is described in Chapter 2.8 (geographical application) of the Blue Guide.

The LVD also applies in the EEA-EFTA States (Liechtenstein, Iceland, and Norway) and Turkey.

Therefore, in the context of this Guide, the terms “European Union”, “Union”, “territory” or 'Member States' also cover the EEA-EFTA States (Liechtenstein, Iceland, and Norway) and Turkey.

Mutual Recognition Agreements (MRAs)

MRAs are agreements established between the Union and the third countries for the purpose of mutual recognition of conformity assessment of regulated products. It is noted that it depends on the scope of each MRA, before deciding if it relates with the LVD.

Specific information on MRAs may be found in Chapter 9.2 (Mutual Recognition Agreements - MRA) of the Blue Guide and the relevant Commission’s website.

MRA with Switzerland

The MRA concluded with Switzerland, which entered into force on 1 June 2002, is a comprehensive agreement. Annex 1, Chapter 9, of the Agreement as amended by Decision No 1/2017 of the Committee established under the Agreement contains adaptations on the LVD. In addition, the relevant Swiss legislation is adapted to the LVD.

The LVD and this Guide shall be read in conjunction with the adaptations in the MRA. The most important adaptations which relate with the obligations of the economic operators are the following:

(a) for the purpose of the obligations in Articles 6(6) and 8(3) of the LVD and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted. In cases where the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;

(b) for the purpose of the obligations in Articles 6(3) and 8(8) of the LVD and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity for 10 years after the equipment has been placed on the market in either the European Union or Switzerland. In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the equipment has been placed on the market in either the European Union or Switzerland;

(c) for the purpose of the obligations in Articles 6(4), second subparagraph, and 8(6), second subparagraph, of the LVD and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.

(d) for the purpose of the obligation in Article 7(2) of the LVD and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 7(1) of the LVD or the corresponding Swiss provisions.

Agreements on Conformity Assessment and Acceptance (ACAAs)

Agreements on Conformity Assessment and acceptance of industrial products are intended to be established between the Union and the government of EU Neighboring countries (for more details see Chapter 9.1 of the Blue Guide).