12.—(1) A notified body must—
(a)decide whether to grant or refuse EU conformity approval in accordance with the provisions of Annex II of the Directive; and
(b)produce an evaluation report recording the activities undertaken to reach a decision on an application made under Module B of Annex II of the Directive.
(2) Where a notified body grants EU conformity approval, it must—
(a)for the type approval of equipment under Module B of Annex II of the Directive, issue a certificate containing the information specified in paragraph 6 of that module;
(b)for approval of a quality system under Module D or E of Annex II of the Directive, notify the manufacturer of its decision in writing, including the conclusions of the audit of the quality system and the reasons for its decision; or
(c)where verifying a product under Module F or G of Annex II of the Directive, issue a certificate of conformity for that product.
(3) Where a notified body refuses EU conformity approval, it must notify the manufacturer, giving detailed reasons for its decision.
(4) A notified body must—
(a)periodically audit a quality system that it has approved; and
(b)provide the manufacturer with a report containing the results of the audit.
(5) Where a notified body knows or has reason to believe that—
(a)equipment to which it has granted EU conformity approval no longer complies with applicable international standards; or
(b)a manufacturer has failed to comply with an obligation under regulation 20(1) to (6),
it must require the manufacturer to take immediate corrective measures to ensure that the equipment complies with applicable international standards; and where necessary, suspend or withdraw its approval for that equipment.
(6) Following the grant of EU conformity approval, a notified body must comply with the notification and provision of information requirements in article 24 and Annex II of the Directive.