PART 2Obligations of economic operators
Chapter 1Manufacturers
Design and manufacture in accordance with essential health and safety requirementsI15
Before placing a product on the market or using a product for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential health and safety requirements.
Technical documentation and conformity assessmentI26
Before placing a product on the market or using it for their own purposes, a manufacturer must—
a
carry out the relevant conformity assessment procedure or have a relevant conformity assessment procedure carried out; and
F1b
draw up the technical documentation referred to—
i
for a product in respect of which the conformity assessment procedure in regulation 39(1)(a) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations;
ii
for a product in respect of which the conformity assessment procedure in regulation 39(1)(b) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations;
iii
for a product in respect of which the conformity assessment procedure in regulation 39(1)(c) is being carried out, in paragraph 2 of Part 6 of Schedule 3A to these Regulations;
iv
for a product in respect of which the conformity assessment procedure in regulation 39(1)(d) is being carried out, in paragraph 2 of Part 7 of Schedule 3A to these Regulations.
F11Declaration of conformity and F12UK markingI37
1
Save for where a product is a component, where the conformity of a product with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market—
a
2
The manufacturer must keep the F15... declaration of conformity up-to-date.
3
Where the conformity of a component with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the component on the market, draw up a written attestation of conformity in accordance with regulation 39(3) (conformity assessment procedures).
4
Subject to paragraph (5), before placing a product on the market, the manufacturer must ensure that each product is accompanied by a copy of the F16... declaration of conformity or attestation of conformity as appropriate.
5
Where a large number of products are delivered to a single user, the batch or consignment may be accompanied by a single copy of the F17... declaration or attestation of conformity as appropriate.
F186
Where a product is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.
Retention of technical documentation and F2... declaration of conformityI48
A manufacturer must keep the technical documentation and the F3... declaration of conformity (or where applicable, the attestation of conformity) drawn up in respect of a product for a period of 10 years beginning on the day on which the product is placed on the market.
Compliance procedures for series productionI59
1
A manufacturer of a product which is manufactured by series production must ensure that, before placing a product on the market, procedures are in place to ensure that any product so manufactured will be in conformity with Part 2.
MonitoringI610
1
When appropriate, with regard to the risks to the health and safety of end-users presented by a product, a manufacturer must—
a
carry out sample testing of a product manufactured by the manufacturer made available on the market,
b
investigate complaints that a product manufactured by the manufacturer is not in conformity with Part 2, and
c
keep distributors informed of any actions carried out under sub-paragraphs (a) and (b).
2
A manufacturer must keep a register of—
a
complaints that a product is not in conformity with Part 2,
b
products which are found not to be in conformity with Part 2, and
c
product recalls.
3
A manufacturer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.
Labelling and packaging of productsI711
1
Before placing a product on the market, a manufacturer must ensure that it bears a type, batch or serial number or other element allowing its identification.
2
If the size or nature of the product does not provide sufficient space for the labelling requirements in paragraph (1), the manufacturer must ensure that the information is provided on the packaging or in a document accompanying the product.
Labelling and packaging of products, other than componentsI812
Save for where a product is a component, before placing a product on the market a manufacturer must ensure that it—
a
bears the specific marking of explosion protection as referred to at paragraph 5(1)(f) of Schedule 1, and
b
where applicable, bears the other markings and information referred to at paragraph 5 of Schedule 1.
Information identifying manufacturerI913
1
Before placing a product on the market, a manufacturer must indicate on the product—
a
the name, registered trade name or registered trade mark of the manufacturer, and
b
a postal address at which the manufacturer can be contacted.
2
Where it is not possible to indicate the information specified in paragraph (1) on the product, the manufacturer must indicate that information—
a
on the product packaging, or
b
in a document accompanying the product.
F63
The information specified in paragraph (1) must be in a language which can be easily understood by end users and the market surveillance authority.
F7Provision of instructions and safety information14
When placing a product on the market, a manufacturer must ensure that a product is accompanied by instructions and safety information that are clear, legible and in easily understandable English.
Duty to take action in respect of a product placed on the market which is considered not to be in conformityI1015
1
A manufacturer who considers, or has reason to believe, that a product which the manufacturer has placed on the market is not in conformity with Part 2, must immediately take the corrective measures necessary to—
a
bring the product into conformity,
b
withdraw the product, or
c
recall the product.
2
Where the product presents a risk, the manufacturer must immediately inform the market surveillance authorityF8... of the risk, giving details of—
a
the respect in which the product is considered not to be in conformity with Part 2, and
b
any corrective measures taken.
Provision of information and cooperationI1116
1
A manufacturer must, further to a reasoned request from the market surveillance authority, and within such period as the market surveillance authority may specify, provide the authority with the information and documentation necessary to demonstrate that the product is in conformity with Part 2—
a
in paper or electronic form, and
b
in a language which can be easily understood by the market surveillance authority.
2
A manufacturer must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—
a
evaluate a product in accordance with regulation 55 (evaluation of a product presenting a risk);
b
eliminate the risks posed by a product which the manufacturer has placed on the market.
Authorised representativesI1217
1
A manufacturer may, by written mandate, appoint a person established in the F9United Kingdom as their authorised representative to perform specified tasks on the manufacturer’s behalf.
2
A manufacturer who has appointed an authorised representative to perform, on the manufacturer’s behalf, a task under these Regulations remains responsible for the proper performance of that task.
3
4
The mandate must allow the authorised representative to do at least the following in relation to a product covered by the mandate—
a
b
perform the manufacturer’s obligations under regulation 16 (provision of information and cooperation).
5
An authorised representative must comply with all duties imposed on the manufacturer in relation to each obligation under these Regulations that the authorised representative is appointed by the mandate to perform and, accordingly as far as those duties are concerned, as well as the penalties for failure to comply with those duties, references in these Regulations (except in this regulation) to the manufacturer are to be taken as including a reference to the authorised representative.