PART 5Obligations of Economic Operators
Application of Part 519
This Part applies only to equipment to which regulation 5(1) applies that is listed in Annex 1 of Merchant Shipping Notice MSN 1874.
Obligations of a Manufacturer20
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.
Obligations of an importer21
An importer which places on the market or on board a ship any equipment accompanied by a declaration of conformity under regulation 14 must ensure that—
a
its name,
b
registered trade name or trade mark, and
c
the address at which it can be contacted,
is on the equipment or, where that is not possible, on the packaging of the equipment or in a document accompanying the equipment or both, as appropriate.
Obligations of an economic operator22
1
On receipt of a request from a market surveillance authority, an economic operator must identify any other economic operator—
a
who has supplied it with equipment, or
b
to whom it has supplied equipment,
during the relevant period.
2
On receipt of a written request from a competent national authority, which includes the reasons for making the request, an economic operator must—
a
provide that authority with all information and documents necessary to show that the equipment meets applicable international standards; and
b
cooperate with that authority in any action it takes to eliminate risks posed by that equipment.
3
Information and documents provided to a competent national authority must be in a language easily understood by, or acceptable to, that authority.