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20.—(1) A manufacturer must—
(a)ensure an EU conformity assessment is carried out using one of the procedures referred to in article 15(2)(a) or (b) of the Directive;
(b)ensure equipment is marked in accordance with regulation 15; and
(c)keep the technical documentation specified in Annex II of the Directive and the EU declaration of conformity for the relevant period.
(2) A manufacturer must undertake to fulfil any obligation arising from a quality system approved under regulation 12(2)(b) and must ensure that quality system is maintained.
(3) A manufacturer must ensure—
(a)its name,
(b)a type, batch or serial number or other element allowing identification of its product,
(c)its registered trade name or trade mark, and
(d)the address at which it can be contacted,
is on any equipment or, where that is not possible, on the packaging of that equipment or in a document accompanying that equipment or both, as appropriate.
(4) A manufacturer must provide with any equipment—
(a)clear instructions and all necessary information for that equipment to be installed and operated safely; and
(b)any other documentation required by international instruments.
(5) Where a manufacturer knows or has reason to believe that its equipment does not comply with applicable international standards, that manufacturer must—
(a)take immediate corrective measures to ensure that the equipment complies with applicable international standards;
(b)withdraw the equipment from the market; or
(c)issue a recall of the equipment.
(6) Where a manufacturer considers that equipment presents a risk, that manufacturer must immediately inform the competent national authority of the risk and provide details of any non-compliance with applicable international standards and any action taken in accordance with paragraph (5).
(7) On request by a competent national authority, a manufacturer must provide to that competent national authority—
(a)samples of equipment approved by a notified body at the manufacturer’s own cost; or
(b)access to such samples.
(8) This regulation applies to an importer or a distributor as if that person were a manufacturer where the importer or distributor—
(a)places equipment on the market or on board a ship under the importer or distributor’s own name or trademark; or
(b)modifies equipment already placed on the market or on board a ship in such a way that compliance with applicable international standards may be affected.
(9) In this regulation—
“clear instructions” means instructions in a form and language which the user easily understands.
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