Regulation 41 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)

if any plastic part is not marked in accordance with paragraph 12 of Schedule 19, the specific reason why the exemption applies;

(b)

the information specified in paragraph 19 of Schedule 19; and

(c)

the details and results of any measurements or calculations carried out in accordance with regulation 43 or Schedules 19 and 20.