F1SCHEDULE 7(Annex II to the Directive)

Annotations:
Amendments (Textual)

CONFORMITY ASSESSMENT PROCEDURES

2

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

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.