PART 4NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Notified bodies
42.—(1) For the purposes of this Part, a notified body is a conformity assessment body—
(a)which has been notified by the Executive to the European Commission, the other Member States and Great Britain—
(i)under regulation 44 (Notification); or
(ii)before the commencement date, in accordance with Article 17 of the ATEX Directive; and
(b)in respect of which no objections are raised by the European Commission or other Member States—
(i)within two weeks of the date of notification, where the notification is accompanied by an accreditation certificate; or
(ii)within two months of the date of notification, where the notification is not accompanied by an accreditation certificate.
(2) Paragraph (1) has effect subject to regulation 48 (Changes to notifications).
Presumption of conformity of notified bodies
43.—(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, the Executive 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.
Notification
44.—(1) The Executive may notify to the European Commission, the other Member States and Great Britain only those conformity assessment bodies established within Northern Ireland 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 makes an application to the Executive for notification and that 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 for which the conformity assessment 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 Executive to verify, recognise and regularly monitor the conformity assessment body’s compliance with the notified body requirements.
(4) The second condition is that the Executive is satisfied that the conformity assessment body meets the notified body requirements.
(5) For the purposes of paragraph (4), the Executive may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body fulfils the notified body requirements.
(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the European Commission, the other Member States and Great Britain, the Executive may—
(a)have regard to any other matter which appears to the Executive to be relevant; and
(b)set conditions that the conformity assessment body shall meet.
(7) The Executive shall inform the European Commission of Northern Ireland’s procedures for the assessment and notification of conformity assessment bodies and of any changes to those procedures.
Contents of notification
45. A notification under regulation 44 (Notification) shall 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; and
(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 meet the notified body requirements.
Monitoring
46.—(1) The Executive shall monitor each notified body with a view to verifying that the notified body—
(a)continues to meet the notified body requirements;
(b)meets any conditions set in accordance with regulation 44(6)(b); and
(c)carries out its functions in accordance with these Regulations.
(2) The Executive shall inform the European Commission of Northern Ireland’s procedures for the monitoring of notified bodies and any changes to those procedures.
United Kingdom Accreditation Service
47. The Executive may authorise the United Kingdom Accreditation Service(1) to carry out the following activities on behalf of the Executive—
(a)assessing whether a conformity assessment body meets the notified body requirements; and
(b)monitoring notified bodies in accordance with regulation 46 (Monitoring).
Changes to notifications
48.—(1) Where the Executive determines that a notified body no longer meets a notified body requirement, or is failing to fulfil its obligations under these Regulations other than conditions set in accordance with regulation 44(6)(b), the Executive shall restrict, suspend or withdraw the body’s status as a notified body under regulation 42.
(2) With the consent of a notified body, or where the Executive determines that a notified body no longer meets a condition set in accordance with regulation 44(6)(b), the Executive may restrict, suspend or withdraw the body’s status as a notified body under regulation 42.
(3) In deciding what action is required under paragraph (1) or (2), the Executive shall have regard to the seriousness of the non-compliance.
(4) Where the Executive takes action under paragraph (1) or (2), the Executive shall immediately inform the European Commission, the other Member States and Great Britain.
(5) Where the Executive 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 shall—
(a)at the request of the Executive, transfer its files relating to the activities it has undertaken as a notified body to another notified body or to the Executive; 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 Executive for a period of 10 years from the date they were created.
Operational obligations of notified bodies
49. When a notified body carries out a relevant conformity assessment procedure, Schedule 3 (Operational obligations of notified bodies) has effect.
Subsidiaries and contractors
50.—(1) Where a notified body subcontracts specific conformity assessment activities, or has such activities carried out by a subsidiary, the activities are only to be treated as having been carried out by a notified body for the purposes of regulation 39 (Conformity assessment procedures) where the conditions in paragraphs (2) and (3) are satisfied.
(2) The notified body shall—
(a)ensure that the subcontractor or subsidiary meets the notified body requirements; and
(b)inform the Executive accordingly.
(3) The notified body shall have obtained the agreement of the client to the use of a subcontractor or subsidiary.
(4) Where a notified body subcontracts specific conformity assessment activities, or has such activities carried out by a subsidiary, the notified body shall, for a period of at least 10 years beginning on the day on which the activities are carried out, keep available for inspection by the Executive 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 46, the Executive shall treat the notified body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.
a company limited by guarantee incorporated in England and Wales under number 03076190