CHAPTER 3

CONFORMITY OF INSTRUMENTS

Presumption of conformity of instruments
Article 12
Instruments which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those standards or parts thereof.

Conformity assessment procedures
Article 13
1
The conformity of instruments to the essential requirements set out in Annex I may be established by either of the following conformity assessment procedures as selected by the manufacturer:
a
Module B as set out in point 1 of Annex II, followed either by Module D as set out in point 2 of Annex II, or by Module F as set out in point 4 of Annex II.
However, Module B shall not be compulsory for instruments which do not use electronic devices and the load-measuring device of which does not use a spring to balance the load. For those instruments not submitted to Module B, Module D1 as set out in point 3 of Annex II or Module F1 as set out in point 5 of Annex II shall apply;
b
Module G as set out in point 6 of Annex II.
2
The documents and correspondence relating to the conformity assessment procedures referred to in paragraph 1 shall be drawn up in one of the official languages of the Member State where those procedures are carried out, or in a language accepted by the body notified in accordance with Article 19.

EU declaration of conformity
Article 14
1
The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Annex I has been demonstrated.
2
The EU declaration of conformity shall have the model structure set out in Annex IV, shall contain the elements specified in the relevant modules set out in Annex II and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the instrument is placed or made available on the market.
3
Where an instrument is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned including their publication references.
4
By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the instrument with the requirements laid down in this Directive.

Conformity marking
Article 15
The conformity of an instrument intended to be used for the applications listed in points (a) to (f) of Article 1(2) with this Directive shall be indicated by the presence, on the instrument, of the CE marking and the supplementary metrology marking as specified in Article 16.

General principles of the CE marking and of the supplementary metrology marking
Article 16
1
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2
The supplementary metrology marking shall consist of the capital letter ‘M’ and the last two digits of the year of its affixing, surrounded by a rectangle. The height of the rectangle shall be equal to the height of the CE marking.
3
The general principles set out in Article 30 of Regulation (EC) No 765/2008 shall apply, mutatis mutandis, to the supplementary metrology marking.

Rules and conditions for affixing the CE marking, the supplementary metrology marking and other markings
Article 17
1
The CE marking and the supplementary metrology marking shall be affixed visibly, legibly and indelibly to the instrument or to its data plate.
2
The CE marking and the supplementary metrology marking shall be affixed before the instrument is placed on the market.
3
The supplementary metrology marking shall immediately follow the CE marking.
4
The CE marking and the supplementary metrology marking shall be followed by the identification number(s) of the notified body or bodies involved in the production control phase as set out in Annex II.
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
5
The CE marking, the supplementary metrology marking and the identification number(s) of the notified body or bodies may be followed by any other mark indicating a special risk or use.
6
Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Restrictive use symbol
Article 18
The symbol referred to in the fourth subparagraph of Article 6(5) and specified in point 3 of Annex III shall be affixed to the devices in a clearly visible and indelible form.