The Recreational Craft Regulations 2017

PART 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Notified bodies

55.  For the purposes of this Part, a notified body is a conformity assessment body—

(a) which has been notified by the Secretary of State, to the European Commission and to the other Member States—

(i) under regulation 56 (notification); or

(ii) before the date these Regulations come into force, in accordance with Article 26 of the Directive; and

(b) in respect of which no objections were raised by the European Commission or other Member States—

(i) within 2 weeks of the date of notification, where notification is accompanied by an accreditation certificate; or

(ii) within 2 months of the date of notification, where the notification is not accompanied by an accreditation certificate.

Notification

56.—(1) The Secretary of State may notify to the European Commission and the other Member States only those conformity assessment bodies that qualify for notification.

(2) A conformity assessment body qualifies for notification if the first and second conditions below are met.

(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become a notified body and the application is accompanied by—

(a) a description of—

(i) the conformity assessment activities that the conformity assessment body intends to carry out;

(ii) the conformity assessment module or modules in respect of which the conformity body claims to be competent; and

(iii) the product for which the conformity assessment body claims to be competent; and either—

(b) an accreditation certificate; or

(c) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body’s compliance with the notified body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the notified body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph 3(b), as sufficient evidence that the conformity assessment body meets the notified body requirements.

(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the European Commission and the other Member States, the Secretary of State may—

(a) have regard to any other matter which appears to the Secretary of State to be relevant; and

(b) set conditions that the conformity assessment body must meet.

(7) The Secretary of State must inform the European Commission of the United Kingdom’s procedures for the assessment and notification of conformity assessment bodies, and any changes to those procedures.

Contents of notification

57.  A notification under regulation 56 (notification) must include—

(a) the details of—

(i) the conformity assessment activities in respect of which the conformity assessment body has made its application for notification;

(ii) the conformity assessment module or modules in respect of which the conformity assessment body has made its application for notification;

(iii) the product in respect of which the conformity assessment body has made its application for notification; and either

(b) an accreditation certificate; or

(c) documentary evidence which attests to—

(i) the conformity assessment body’s competence; and

(ii) the arrangements in place to ensure that the conformity assessment body will be monitored regularly and will continue to satisfy the notified body requirements.

Presumption of conformity of notified bodies

58.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a harmonised standard (or part of such a standard), the reference of which has been published in the Official Journal of the European Union, the Secretary of State is to presume that the conformity assessment body meets the notified body requirements covered by that standard (or part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Monitoring of notified bodies

59.—(1) The Secretary of State must monitor each notified body with a view to verifying that the notified body—

(a) continues to meet the notified body requirements;

(b) complies with any condition set in accordance with regulation 56(6)(b); and

(c) carries out its functions in accordance with these Regulations.

(2) The Secretary of State must inform the European Commission of the United Kingdom’s procedures for the monitoring of notified bodies, and any changes to those procedures.

Authorisation of the United Kingdom Accreditation Service

60.  The Secretary of State may authorise the United Kingdom Accreditation Service (a company limited by guarantee incorporated in England and Wales under number 03076190) to carry out the following activities on behalf of the Secretary of State—

(a) assessing applications for designation as a notified body made under regulation 56 (application for designation as a notified body); and

(b) monitoring notified bodies required by regulation 59 (monitoring of notified bodies).

Changes to notifications

61.—(1) Where the Secretary of State determines that a notified body no longer meets a notified body requirements or that it is failing to fulfil its obligations under these Regulations other than a condition set in accordance with regulation 56(6)(b), the Secretary of State must restrict, suspend or withdraw the body’s status as a notified body under regulation 55.

(2) With the consent of the notified body, or where the Secretary of State determines that a notified body no longer meets a condition set in accordance with regulation 56(6)(b), the Secretary of State may restrict, suspend or withdraw the body’s status as a notified body under regulation 55.

(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) Where the Secretary of State takes action under paragraph (1) or (2), the Secretary of State must immediately inform the European Commission and the other Member States.

(5) Where the Secretary of State has taken action under paragraph (1) or (2), or where the notified body has ceased its activity, the notified body must—

(a) at the request of the Secretary of State, 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) in the absence of a request under sub-paragraph (a), keep its files relating to the activities it has undertaken as a notified body available for inspection by the Secretary of State and the market surveillance authorities for a period of 10 years from the date they were created.

Operational requirements of notified bodies

62.  When a notified body carries out a relevant conformity assessment procedure, Schedule 12 (operational requirements of notified bodies) has effect.

Subsidiaries and contractors

63.—(1) Where a notified body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the tasks are only to be treated as having been carried out by a notified body for the purposes of regulations 44 to 47 where the conditions in paragraphs (2) and (3) are satisfied.

(2) The notified body must—

(a) ensure that the subcontractor or subsidiary meets the notified body requirements; and

(b) inform the Secretary of State accordingly.

(3) The notified body must have obtained the agreement of the client economic operator to the use of a subcontractor or subsidiary.

(4) Where a notified body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the notified body must, for a period of 10 years beginning on the day on which the tasks are carried out, keep at the disposal of the Secretary of State the documentation concerning—

(a) the assessment of the qualifications of the subcontractor or the subsidiary; and

(b) the conformity assessment activities carried out by the subcontractor or subsidiary.

(5) When monitoring a notified body in accordance with regulation 59 (monitoring of notified bodies), the Secretary of State must treat the notified body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.

Appeal against a change to a notification

64.—(1) Where the Secretary of State intends to restrict, suspend or withdraw a notification in accordance with regulation 61 (changes to notifications) the Secretary of State must give notice in writing to the notified body concerned that its notification will be restricted, suspended or withdrawn.

(2) A written notice provided in accordance with paragraph (1) must—

(a) state the date on which the notice is issued;

(b) state of the reasons why the notification is being restricted, suspended or withdrawn;

(c) state the date on which the restriction, suspension or withdrawal of the notification is to take effect;

(d) where a notification has been restricted or suspended, state what the effect of that restriction or suspension is upon the notified body;

(e) inform the notified body of its right to make representations to the Secretary of State, in writing, within 14 days of the date on the notice, against this decision.

(3) Where a notified body submits written representations to the Secretary of State, the Secretary of State must respond to those representations within 21 days of the date on which those representations are received, stating whether, having considered those representations, the notice issued under paragraph (1) will be modified or withdrawn.