Regulation 5 Conformity assessment

(1)

For the purposes of the conformity assessment procedure referred to in Schedule 1A to the 2010 Regulations^f1, 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 the product must contain—

(a)

a copy of the product information provided in accordance with paragraph 4 of Schedule 1;

(b)

the information specified in paragraph 5 of Schedule 1;and

(c)

the details and results of any measurements or calculations carried out in accordance with regulation 7.

Annotations

Footnotes

f1: Schedule 1A was inserted by S.I. 2019/539, as amended by S.I. 2020/1528.