11.—(1) For the purposes of the conformity assessment procedure referred to in Schedule 1A to the 2010 Regulations, a manufacturer assessing whether a product conforms with these Regulations must use either—
(a)the internal design control procedure set out in Part 1 of that Schedule; or
(b)the management system procedure set out in Part 2 of that Schedule.
(2) The technical documentation file required for the conformity assessment of a product must contain—
(a)a copy of the product information provided in accordance with paragraph 4 of Schedule 3;
(b)the information specified in paragraph 5 of Schedule 3; and
(c)the details and results of any measurements or calculations carried out in accordance with regulation 13 or Schedule 4.