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[F1SCHEDULE 7E+W+S(Annex II to the Directive)

CONFORMITY ASSESSMENT PROCEDURESE+W+S

2.3.1.  The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the instruments concerned.E+W+S

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 approved body;

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system; and

(e)the technical documentation of the approved type and a copy of the type examination certificate.]