ANNEX IIU.K.CONFORMITY ASSESSMENT PROCEDURES
5. Module F1: Conformity based on product verification U.K.
5.1.Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 5.2, 5.3 and 5.6 and ensures and declares on his sole responsibility that the instruments concerned, which have been subject to the provisions of point 5.4, are in conformity with the requirements of this Directive that apply to them.U.K.
5.2. Technical documentation U.K.
5.2.1.The manufacturer shall establish the technical documentation. 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. The technical documentation shall, wherever applicable, contain at least the following elements:U.K.
(a)
a general description of the instrument;
(b)
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
(c)
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
(d)
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
(e)
results of design calculations made, examinations carried out, etc.;
5.2.2.The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market.U.K.
5.3. Manufacturing U.K.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the applicable requirements of this Directive.
5.4. Verification U.K.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the conformity of the instruments with the applicable requirements of this Directive.
The examinations and tests to check the conformity with those requirements shall be carried out by examination and testing of every instrument as specified in point 5.5.
5.5. Verification of conformity by examination and testing of every instrument U.K.
5.5.1.All instruments shall be individually examined and appropriate tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify conformity with the requirements that apply to them. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.U.K.
5.5.2.The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility.U.K.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
5.6. Conformity marking and EU declaration of conformity U.K.
5.6.1.The manufacturer shall affix the CE marking and the supplementary metrology marking, set out in this Directive, and, under the responsibility of the notified body referred to in point 5.4, the latter’s identification number to each individual instrument that satisfies the applicable requirements of this Directive.U.K.
5.6.2.The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it 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 model for which it has been drawn up.U.K.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
If the notified body referred to in point 5.5 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the instruments.
5.7.If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the instruments during the manufacturing process.U.K.
5.8. Authorised representative U.K.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in points 5.2.1 and 5.3.