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1. ‘Internal production control’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them.

2. Technical documentation The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument.

3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.

4. Conformity marking and EU declaration of conformity 4.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive to each individual measuring instrument that satisfies the applicable requirements of this Directive.

4.2. The manufacturer shall draw up a written EU declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the measuring instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

5. Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS 1. Internal production control plus supervised instrument checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them.

2. Technical documentation The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument.

3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.

4. Instrument checks At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the instrument, taking into account, inter alia, the technological complexity of the instruments and the quantity of production. An adequate sample of the final measuring instruments, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard, and/or normative document, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instruments with the relevant requirements of this Directive. In the absence of a relevant harmonised standard or normative document, the accredited in-house body or notified body concerned shall decide on the appropriate tests to be carried out. In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the accredited in-house body or notified body shall take appropriate measures. Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.

5. Conformity marking and EU declaration of conformity 5.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive to each individual instrument that satisfies the applicable requirements of this Directive.

5.2. The manufacturer shall draw up a written EU declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

6. Authorised representative The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility provided that they are specified in the mandate. MODULE B: EU- TYPE EXAMINATION 1. ‘EU-type examination’ is the part of a conformity assessment procedure in which a notified body examines the technical design of an instrument and verifies and attests that the technical design of the instrument meets the requirements of this Directive that apply to it.

2. EU-type examination may be carried out in either of the following manners:

(a) examination of a specimen, representative of the production envisaged, of the complete measuring instrument (production type), (b) assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type);

(c) assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type). The notified body decides on the appropriate manner and the specimens required.

3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include:

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b) a written declaration that the same application has not been lodged with any other notified body;

(c) the technical documentation as described in Article 18. The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument.

The application shall in addition contain, wherever applicable:

(d) the specimens, representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme;

(e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards, and/or normative documents have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4. The notified body shall: For the instrument: 4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument; For the specimen(s):

4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications; 4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and normative documents, these have been applied correctly; 4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards, and/or normative documents have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Directive; 4.5. agree with the manufacturer on the location where the examinations and tests will be carried out. For the other parts of the measuring instrument: