16.—(1) In order for an application for an authorisation to be valid a project entity must—
(a)engage a notified body to act in carrying out the verification assessment procedure, other than in relation to notified national technical rules, in accordance with regulation 17;
(b)ensure that a notified body (whether that originally engaged or another) continues to be engaged until authorisation under these Regulations is given or refused; and
(c)if there are applicable notified national technical rules, engage a designated body, or if the engagement is made before the day which is one year after the coming into force of these Regulations either a designated body or a notified body, to carry out the verification assessment procedure in relation to the notified national technical rules in accordance with regulation 17.
(2) The engagement of a notified body under paragraph (1)(a) must be made—
(a)before completion of the design stage of the project subsystem; or
(b)before commencement of the manufacture stage of the project subsystem,
whichever is the earlier.
(3) A project entity must not draw up a verification declaration in relation to that project subsystem unless—
(a)the project entity is satisfied the essential requirements are met (including interfaces with the rail system);
(b)the verification assessment procedure has been carried out by a notified body, and if applicable the body engaged under paragraph (1)(c), in accordance with regulation 17;
(c)a certificate of verification has been drawn up by a notified body, and if applicable the body engaged under paragraph (1)(c), in accordance with Annex VI to the Directive; and
(d)a technical file has been prepared containing the information and documents specified in regulation 17(2) and, if applicable, regulation 17(5).
(4) A notified body engaged to assess conformity with notified national technical rules may only continue to carry out that function after the beginning of the day which is one year after the coming into force of these Regulations if it has also been appointed as a designated body under regulation 31 (whether or not the appointment as a notified body remains in place).
(5) This regulation and regulation 17 do not apply where an authorisation is being applied for under regulation 5(1)(c).
(6) Where regulation 9 or 10 applies, this regulation and regulation 17 only apply to the extent necessary to satisfy the Safety Authority that an authorisation must be granted under these Regulations.