Regulation 12 EC unit verification
All necessary measures shall be taken to secure that the manufacturing process for instruments intended for EC unit verification shall ensure conformity with the requirements of the Directive which apply to them.
after the procedures set out in paragraphs (4) and (5) below have been completed the manufacturer or his authorised representative shall—
affix the CE marking and the sticker to the instrument (by way of confirmation that it may be used for a Schedule 3 application) in accordance with regulation 18; and
draw up a written declaration of conformity that the instrument conforms with the requirements of the Directive which apply to it.
Subject to paragraphs (6) and (7) below, an application for the carrying out of the appropriate examinations and tests with a view to EC unit verification shall be made in writing to the Secretary of State by the manufacturer or his authorised representative; and each application shall be accompanied by the design documentation relating to the instrument.
Where the Secretary of State is satisfied, on application made to him under paragraph (3) above and after carrying out, or after having carried out, the appropriate examinations and tests, that the instrument (if properly installed and used for the purposes for which it is intended) satisfies the provisions of the Directive that apply to it—
the Secretary of State shall in accordance with regulation 18—
affix, or cause to be affixed, his identification number to the instrument, and
provide to the manufacturer or his authorised representative a written certificate of conformity relating to the tests carried out; and
the manufacturer or his authorised representative shall ensure that he is able to provide the certificate to any person entitled to see it.
Where the Secretary of State is not si satisfied, he shall decline to affix his identification number to the instrument and to provide to the manufacturer or his authorised representative a written certificate of conformity under paragraph (4) above; and he shall in writing inform the applicant of his decision and of the grounds for his decision.
In the case of an instrument—
to which the identification number, CE marking and sticker have been affixed; and
to which a disqualification sticker has been affixed under regulation 24, 25 or 27 or under any corresponding provision in the law of a member State other than the United Kingdom,
the foregoing provisions of this regulation shall have effect as modified under paragraph (7) below.
In a case to which paragraph (6) above applies an application under paragraph (3) above may be made by any person established in the Community and—
in paragraph (3) above, the words after the semi-colon shall not have effect; and
in paragraph (4) above, for sub-paragraphs (a) and (b) there shall be substituted the words “the Secretary of State shall in accordance with regulation 18 affix, or cause to be affixed, to the instrument his identification number and the re-qualification sticker.”.