[F13.5.1. 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;
(e)the technical documentation referred to in point 3.2.]
Textual Amendments
F1Schs. 6-9 inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 26 para. 45 (with Sch. 26 para. 5) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)