Article 10 of 89/336/EEC (EMC Directive)
1. In the case of apparatus for which the manufacturer has applied the standards
referred to in Article 7 (1), the conformity of apparatus with this Directive shall be
certified by an EC declaration of conformity issued by the manufacturer or his authorized
representative established within the Community. The declaration shall be held at the
disposal of the competent authority for ten years following the placing of the apparatus
on the market.
The manufacturer or his authorized representative established within the Community
shall also affix the EC conformity mark to the apparatus or else to the packaging,
instructions for use or guarantee certificate.
Where neither the manufacturer nor his authorized representative is established within
the Community, the above obligation to keep the EC declaration of conformity available
shall be the responsibility of the person who places the apparatus on the Community
market.
The provisions governing the EC declaration and the EC mark are set out in Annex I.
2. In the case of apparatus for which the manufacturer has not applied, or has applied
only in part, the standards referred to in Article 7 (1) or failing such standards, the
manufacturer or his authorized representative established within the Community shall hold
at the disposal of the relevant competent authorities, as soon as the apparatus is placed
on the market, a technical construction file. This file shall describe the apparatus, set
out the procedures used to ensure conformity of the apparatus with the protection
requirements referred to in Article 4 and include a technical report or certificate, one
or other obtained from a competent body.
The file shall be held at the disposal of the competent authorities for ten years
following the placing of the apparatus on the market.
Where neither the manufacturer nor his authorized representative is established within the
Community, this obligation to keep a technical file available shall be the responsibility
of the person who places the apparatus on the Community market.
The conformity of apparatus with that described in the technical file shall be certified
in accordance with the procedure laid down in paragraph 1.
Member States shall presume, subject to the provisions of this paragraph, that such
apparatus meets the protection requirements referred to in Article 4.
3. Where the standards referred to in Article 7 (1) are not yet in existence, and without
prejudice to the provisions of paragraph 2 of this Article, the apparatus concerned may,
on a transitional basis until 31 December 1992 at the latest, continue to be governed by
the national arrangements in force on the date of adoption of this Directive, subject to
the compatibility of such arrangements with the provisions of the Treaty.
4. Conformity of apparatus covered by Article 2 (2) of Directive 86/361/EEC with the
provisions of this Directive shall be certified in accordance with the procedure laid down
in paragraph 1 once the manufacturer or his authorized representative established within
the Community has obtained an EC type-examination certificate concerning this apparatus
issued by one of the notified bodies referred to in paragraph 6 of this Article.
5. The conformity of apparatus designed for the transmission of radiocommunications, as
defined in the International Telecommunication Union Convention, with the provisions of
this Directive shall be certified in accordance with the procedure laid down in paragraph
1 once the manufacturer or his authorized representative established within the Community
has obtained an EC type-examination certificate concerning this apparatus issued by one of
the notified bodies referred to in paragraph 6 below.
This provision shall not apply to the above apparatus where it is designed and intended
exclusively for radio amateurs within the meaning of Article 2 (3).
6. Each Member State shall notify the Commission and the other Member States of the
competent authorities referred to in this Article and of the bodies responsible for
issuing the EC type-examination certificates referred to in paragraph4 and 5. The
Commission shall publish a list of those authorities and bodies, for information purposes,
in the Official Journal of the European Communities and shall ensure that the
list is updated.
Such notification shall state whether those bodies are competent for all apparatus covered
by this Directive or whether their responsibility is limited to certain specific areas.
Member States shall apply the criteria listed in Annex II for the assessment of the bodies
to be notified.
Bodies which comply with the assessment criteria fixed by the relevant harmonized
standards shall be presumed to comply with the aforementioned criteria.
A Member State which has notified a body must withdraw approval if it finds that the body
no longer meets the criteria listed in Annex II. It shall forthwith inform the Commission
and the other Member States thereof.
Annex 1 of 89/336/EEC (EMC Directive)
1. EC declaration of conformity
The EC declaration of conformity must contain the following:
