ANNEX IIU.K.CONFORMITY ASSESSMENT PROCEDURES
4. Module F: Conformity to type based on product verification U.K.
4.1.Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2 and 4.5 and ensures and declares on his sole responsibility that the instruments concerned, which have been subject to the provisions of point 4.3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.U.K.
4.2. 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 approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
4.3. Verification U.K.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the instruments with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
The examinations and tests to check the conformity of the instruments with the appropriate requirements shall be carried out by examination and testing of every instrument as specified in point 4.4.
4.4. Verification of conformity by examination and testing of every instrument U.K.
4.4.1.All instruments shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.U.K.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
4.4.2.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 available for inspection by the national authorities for 10 years after the instrument has been placed on the market.
4.5. Conformity marking and EU declaration of conformity U.K.
4.5.1.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 4.3, the latter’s identification number to each individual instrument that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.U.K.
4.5.2.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 4.3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the instruments.
4.6.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.
4.7. 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 point 4.2.