PART 4F2Notification of conformity assessment bodies
F2Approval of Conformity Assessment Bodies
F2Operational matters in relation to approved bodies, recognised third party organisations and user inspectoratesE262
1
Subject to the terms of its appointment, an approved body, recognised third party organisation or user inspectorate must carry out the conformity assessment activities and procedures—
a
in respect of which the body's approval was given under regulation 55, 56 or 57 (as the case may be); or
b
in respect of which the body's notification to the European Commission was made as a notified body, a recognised third party organisation or a user inspectorate (as the case may be).
2
Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 6.
3
An approved conformity assessment body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body—
a
to issue a Type examination certificate referred to in Schedule 1A, or
b
to affix, or cause to be affixed, the body's identification number pursuant to regulation 49 (UK marking), where applicable.
Changes to notificationsE162
1
Where the Secretary of State determines that a notified body or recognised third party organisation—
a
no longer meets a notified body requirement, or
b
is failing to fulfil any of its obligations under these Regulations other than conditions set in accordance with regulation 55(2)(b),
the Secretary of State must restrict, suspend or withdraw that body's status as a notified body or recognised third party organisation under regulation 51 or 52, as the case may be.
2
With the consent of the notified body or recognised third party organisation, or where the Secretary of State determines that a notified body or recognised third party organisation no longer meets a condition set in accordance with regulation 55(2)(b), the Secretary of State may restrict, suspend or withdraw the body's status as a notified body or recognised third party organisation under regulation 51 or 52, as the case may be.
3
In deciding what action is required under paragraph (1), the Secretary of State must have regard to the seriousness of the failure.
4
Before taking action under paragraph (1) or (2), the Secretary of State must—
a
give notice in writing that the Secretary of State intends to take such action and the reasons for taking such action; and
b
give the notified body or recognised third party organisation an opportunity to make representations within a reasonable period from the date of that 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 or recognised third party organisation under paragraph (1) or (2), or where a notified body or recognised third party organisation has ceased its activity, the body must—
a
on the request of the Secretary of State, transfer its files relating to the activities it has undertaken as a notified body or recognised third party organisation to another notified body or recognised third party organisation or to the Secretary of State; or
b
in the absence of a request under sub-paragraph (a), ensure that its files relating to the activities it has undertaken as a notified body or recognised third party organisation are kept available for inspection by the Secretary of State and enforcing authorities for a period of 10 years from the date they were 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. 24 para. 35 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/852, reg. 1, Sch. 1 para. 1(m)); 2020 c. 1, Sch. 5 para. 1(1)