reg 16 Role of project entity
(1) In order for an application for an authorisation to be valid a project entity must— (a) engage an EU notified body to carry out the EC verification assessment procedure, or engage an approved body to carry out the UK verification assessment procedure, other than in relation to UK specific rules; (b) ensure that an EU notified body or an approved 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 UK specific rules , engage a designated body, ... to carry out the UK verification assessment procedure in relation to the UK specific rules in accordance with regulation 17 and Schedule 4 . (2) The engagement of an EU notified body or an approved 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 UK declaration of verification 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) either— (i) the EC verification assessment procedure has been carried out by an EU notified body, or (ii) the UK verification assessment procedure has been carried out by an approved body, and, if applicable in either case, the UK verification assessment procedure has been carried out by a designated body; (c) either— (i) an EC certificate of verification has been drawn up by an EU notified body, or (ii) a UK certificate of verification has been drawn up by an approved body, and, if applicable in either case, a UK certificate of verification has been drawn up by a designated body; 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) This regulation and regulation 17 do not apply where an authorisation is being applied for under regulation 6(1) . (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.