The Supply of Machinery (Safety) Regulations 2008

Designation and monitoring of UK notified bodies

16.—(1) The Secretary of State may designate a person to carry out conformity assessment.

(2) Except as provided in paragraph (4), any such designation (a “notified body designation”) shall be made in accordance with paragraphs (5) to (9) of this regulation.

(3) A person in respect of whom—

(a) a notified body designation has been made under this regulation; and

(b) whose designation has been notified by the Secretary of State to the Commission and the other EEA states under Article 14(1) of the Directive,

is a “UK notified body” to the extent that that designation remains in effect.

(4) If a person holds an appointment as a United Kingdom approved body under the 1992 Regulations which has been notified to the Commission and the other EEA states under Article 9(1) of Directive 98/37/EC and has not been terminated—

(a) the appointment—

(i) is a “notified body designation” for the purposes of these Regulations; and

(ii) shall be varied in accordance with regulation 17 to the extent that it is necessary or expedient to vary it to take account of the repeal of Directive 98/37/EC and the revocation of the 1992 Regulations and their replacement by the Directive and these Regulations; and

(b) that person is a “UK notified body” to the extent that the appointment remains in effect.

(5) Except where paragraph (4) applies, any person wishing to be a UK notified body must apply to the Secretary of State for designation under this regulation.

(6) A notified body designation shall not be made unless the Secretary of State is satisfied that the person in respect of whom it is to be made meets the criteria specified in Annex XI (Part 11 of Schedule 2) (the “notified body criteria”).

(7) A person who meets the assessment criteria laid down in a published harmonised standard shall be presumed to meet that part of the notified body criteria which corresponds to the criteria in that standard.

(8) A notified body designation—

(a) shall be in writing;

(b) shall specify the conformity assessment procedures that the person designated may carry out;

(c) may relate to all the categories of machinery listed in Annex IV (Part 4 of Schedule 2) or to such of those categories as are specified in the designation;

(d) may designate a person for a specified period; and

(e) may be made subject to such other conditions as are specified in the designation, including conditions which are to apply upon or following termination of the designation.

(9) In making a notified body designation the Secretary of State may have regard (in addition to the notified body criteria) to any other matter which appears to the Secretary of State to be relevant.

(10) The Secretary of State shall, from time to time, publish a list of UK notified bodies, identifying, in the case of each UK notified body, the description of machinery for which that notified body is designated.

(11) The Secretary of State shall, from time to time, carry out an inspection of each UK notified body with a view to verifying that it—

(a) meets the notified body criteria;

(b) complies with any condition to which its designation is subject; and

(c) complies with these Regulations.

(12) A UK notified body shall comply with any request of the Secretary of State to provide information relevant to determining its compliance with the notified body criteria, these Regulations, or any condition to which its designation is subject.