PART 4F2Notification of conformity assessment bodies
F2Approval of Conformity Assessment Bodies
E1F2Subsidiaries and contractors49
1
An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—
a
the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;
b
the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and
c
the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.
2
The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).
3
Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—
a
the assessment of the qualifications of the subcontractor or the subsidiary; and
b
the conformity assessment activity carried out by the subcontractor or subsidiary.
4
In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006.
Changes to notifications49
1
Where the Secretary of State determines that a notified body no longer meets a notified body requirement, or that it is failing to fulfil its obligations under these Regulations other than a condition set in accordance with regulation 44(6)(b), the Secretary of State must restrict, suspend or withdraw the body's status as a notified body under regulation 43.
2
With the consent of a notified body, or where the Secretary of State determines that a notified body no longer meets a condition set in accordance with regulation 44(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as a notified body under regulation 43.
3
In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.
4
Before taking action under paragraph (1) or (2), the Secretary of State must—
a
give notice in writing to the notified body that the Secretary of State intends to take such action and the reasons for it; and
b
give the notified body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice and consider any such representations.
5
Where the Secretary of State takes action under paragraph (1) or (2), the Secretary of State must immediately inform the Commission and the other F1relevant states.
6
Where the Secretary of State has taken action in respect of a notified body under paragraph (1) or (2), or where a notified body has ceased its activity, the notified body must, at the request of the Secretary of State—
a
transfer its files relating to the activities it has undertaken as a notified body to another notified body or to the Secretary of State; or
b
keep its files relating to the activities it has undertaken as a notified body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date on which the relevant document was created.
Pt. 4 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 20 para. 28 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2, and The Product Safety and Metrology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/852), regs. 2(2), 4(2), Sch. 1 para. 1(i), (iv)); 2020 c. 1, Sch. 5 para. 1(1)