2.3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.U.K.
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 notified 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 EU-type examination certificate.