ANNEX IIU.K. CONFORMITY ASSESSMENT PROCEDURES
4.EC unit verificationU.K.
4.1.EC unit verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instrument, generally designed for a specific application, which has been issued with the certificate referred to in point 4.2 conforms to the requirements of this Directive that apply to it. The manufacturer or his authorised representative shall affix the ‘CE’ conformity marking to the instrument and shall draw up a written declaration of conformity.U.K.
4.2.The notified body shall examine the instrument and carry out the appropriate tests, as set out in the relevant harmonised standard(s) referred to in Article 6(1), or equivalent tests, in order to ensure its conformity with the relevant requirements of this Directive.U.K.
The notified body shall affix, or cause to be affixed, its identification number to the instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity concerning the tests carried out.
4.3.The aim of the technical documentation relating to the design of the instrument, as referred to in Annex III, is to enable conformity with the requirements of this Directive to be assessed and the design, manufacture and operation of the instrument to be understood. It must be accessible to the notified body.U.K.
4.4.The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.U.K.