Regulation 17 Conformity assessment
(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 declared values of the parameters referred to in paragraphs 6 to 12 of Schedule 6;
(b)
the information specified in paragraph 15 of Schedule 6; and
(c)
the details and results of any measurements or calculations carried out in accordance with regulation 19 or Schedule 7.