PART 2Obligations of economic operators
CHAPTER 2Manufacturers
Design and manufacture in accordance with essential requirements7
Before placing radio equipment on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.
Construction must allow operation F2without infringement of requirementsE18
Construction must allow operation in at least one F4relevant StateE28
Before placing radio equipment on the market, a manufacturer must ensure it has been constructed so that the radio equipment can be operated in at least one F5relevant state without causing an infringement of the applicable requirements on the use of the radio spectrum in the relevant F5relevant state or F6relevant states.
Technical documentation and conformity assessment9
Before placing radio equipment on the market, a manufacturer must—
a
draw up the relevant technical documentation in accordance with regulation 45 (technical documentation), and
b
ensure the relevant conformity assessment procedure is carried out.
F7Declaration of conformity and F8UK markingE310
1
Where the compliance of radio equipment with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the radio equipment on the market—
a
2
The manufacturer must keep the F13... declaration of conformity up to date.
F143
Where radio equipment 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.
EU declaration of conformity and CE markingE410
1
Where the compliance of radio equipment with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the radio equipment on the market—
a
draw up an EU declaration of conformity in accordance with regulation 42 (EU declaration of conformity), and
b
affix the CE marking in accordance with regulation 44 (CE marking).
2
The manufacturer must keep the EU declaration of conformity up to date.
3
Where radio equipment is subject to more than one F15NI Protocol obligation requiring an EU declaration of conformity to be drawn up, the manufacturer must draw up a single EU declaration of conformity which—
a
meets the requirements of all of the EU instruments concerned,
b
identifies the EU instruments, and
c
includes references to the publication of those EU instruments in the Official Journal.
Retention of technical documentation and F16... declaration of conformityE1911
A manufacturer must, for a period of 10 years beginning on the day on which the radio equipment is placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to radio equipment—
a
a copy of the F17... declaration of conformity, and
b
the technical documentation.
Retention of technical documentation and EU declaration of conformityE2011
A manufacturer must, for a period of 10 years beginning on the day on which the radio equipment is placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to radio equipment—
a
a copy of the EU declaration of conformity, and
b
the technical documentation.
Identification of the radio equipment and manufacturerE512
1
Before placing radio equipment on the market, a manufacturer must ensure that the radio equipment bears—
a
a type, batch or serial number, or
b
another element which allows the radio equipment to be identified.
2
Before placing radio equipment on the market, a manufacturer must indicate on the radio equipment—
a
the name, registered trade name or registered trade mark of the manufacturer,
b
a postal address at which the manufacturer can be contacted.
3
The information specified in paragraph (2) must be in a language which can be easily understood by end-users and the F19enforcing authority.
4
Where the size or nature of the radio equipment prohibits a manufacturer from complying with the requirement in paragraph (1) or paragraph (2), the manufacturer must provide the required information either on the radio equipment's packaging or in a document which accompanies the radio equipment.
5
The manufacturer's postal address must indicate a single point at which the manufacturer can be contacted.
Identification of the radio equipment and manufacturerE612
1
Before placing radio equipment on the market, a manufacturer must ensure that the radio equipment bears—
a
a type, batch or serial number, or
b
another element which allows the radio equipment to be identified.
2
Before placing radio equipment on the market, a manufacturer must indicate on the radio equipment—
a
the name, registered trade name or registered trade mark of the manufacturer,
b
a postal address at which the manufacturer can be contacted.
3
The information specified in paragraph (2) must be in a language which can be easily understood by end-users and the competent national authority in the F18relevant state in which it is to be made available to such end-users.
4
Where the size or nature of the radio equipment prohibits a manufacturer from complying with the requirement in paragraph (1) or paragraph (2), the manufacturer must provide the required information either on the radio equipment's packaging or in a document which accompanies the radio equipment.
5
The manufacturer's postal address must indicate a single point at which the manufacturer can be contacted.
Instructions and information to be included with the radio equipmentE713
1
When placing radio equipment on the market, a manufacturer must ensure that radio equipment is accompanied with instructions and safety information which—
F22a
are clear, legible and in easily understandable English,
b
include information required to use the radio equipment in accordance with its intended use, F23and
c
include a description of accessories and components, including software, which allow the radio equipment to operate as intended F24.
F25d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
In the case of radio equipment which can intentionally emit radio waves, the manufacturer must also include information about—
a
the frequency band or bands in which the radio equipment can operate, and
b
the maximum radio-frequency power transmitted in the frequency band or bands in which the radio equipment operates.
3
When placing radio equipment on the market, a manufacturer must ensure that each item of radio equipment is accompanied by either a copy of the F26... declaration of conformity or a simplified F26... declaration of conformity drawn up in accordance with regulation 43 (simplified F26... declaration of conformity).
F274
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instructions and information to be included with the radio equipmentE813
1
When placing radio equipment on the market, a manufacturer must ensure that radio equipment is accompanied with instructions and safety information which—
a
are in a language which can be easily understood by consumers and other end-users in the F20relevant state in which the radio equipment is to be made available to such consumers and other end-users,
b
include information required to use the radio equipment in accordance with its intended use,
c
include a description of accessories and components, including software, which allow the radio equipment to operate as intended, and
d
are clear and understandable.
2
In the case of radio equipment which can intentionally emit radio waves, the manufacturer must also include information about—
a
the frequency band or bands in which the radio equipment can operate, and
b
the maximum radio-frequency power transmitted in the frequency band or bands in which the radio equipment operates.
3
When placing radio equipment on the market, a manufacturer must ensure that each item of radio equipment is accompanied by either a copy of the EU declaration of conformity or a simplified EU declaration of conformity drawn up in accordance with regulation 43 (simplified EU declaration of conformity).
4
Where the radio equipment is to be made available to consumers and other end-users in F21Northern Ireland, the language which can be easily understood is English.
Information to be included where there are restrictions on putting into service or requirements for authorisation of useE914
F461
Where there are restrictions on putting into service or requirements for authorisation of use in the United Kingdom in respect of the radio equipment, a manufacturer must present information which identifies the types of restrictions on putting into service or requirements for authorisation of use that apply.
2
The information referred to in paragraph (1) must—
a
be completed in the instructions required by regulation 13,
F483
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information to be included where there are restrictions on putting into service or requirements for authorisation of useE1014
1
Where there are restrictions on putting into service or requirements for authorisation of use, a manufacturer must include information on the packaging of the radio equipment which identifies the F33relevant states and the geographical area within a F34relevant state where the restrictions on putting into service or the requirements for authorisation of use exist.
2
The information referred to in paragraph (1) must—
a
be completed in the instructions required by regulation 13,
F322A
The identification of the United Kingdom in respect of Northern Ireland must be indicated by the abbreviation “UK(NI)”.
3
Paragraph (2)(b) of this Regulation applies to radio equipment placed on the market or after 8th August 2018.
Duty to take action in respect of radio equipment placed on the market which is considered not to be in conformityE1115
1
A manufacturer who considers, or has reason to believe, that radio equipment which they have placed on the market is not in conformity with Part 2, if appropriate, must immediately take the corrective measures necessary to—
a
bring the radio equipment into conformity,
b
withdraw the radio equipment, or
c
recall the radio equipment.
2
Where the radio equipment presents a risk, the manufacturer must immediately inform the market surveillance authority F35... of the risk, giving details of—
a
the respect in which the radio equipment is considered not to be in conformity with Part 2, and
b
any corrective measures taken and the results of those measures.
Duty to take action in respect of radio equipment placed on the market which is considered not to be in conformityE1215
1
A manufacturer who considers, or has reason to believe, that radio equipment which they have placed on the market is not in conformity with Part 2, if appropriate, must immediately take the corrective measures necessary to—
a
bring the radio equipment into conformity,
b
withdraw the radio equipment, or
c
recall the radio equipment.
2
Where the radio equipment presents a risk, the manufacturer must immediately inform the market surveillance authority, and the competent national authorities of any other F36relevant state in which the manufacturer made the radio equipment available on the market, of the risk, giving details of—
a
the respect in which the radio equipment is considered not to be in conformity with Part 2, and
b
any corrective measures taken and the results of those measures.
Provision of information and cooperationE1316
F371
Following a request from the enforcing authority, the manufacturer must, within such reasonable period as the authority may specify, provide the authority concerned with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.
2
A request referred to in paragraph (1)—
a
is one that was made during the period of 10 years beginning on the day that the manufacturer places the radio equipment on the market, and
b
must be accompanied by the reasons for making the request.
3
The information referred to in paragraph (1)—
a
may be provided in electronic form, and
b
must be in a language which can be easily understood by the authority concerned.
4
A manufacturer must, at the request of the authority concerned, cooperate with that authority on any action taken to—
a
evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk),
b
eliminate the risks posed by radio equipment which the manufacturer has placed on the market.
Provision of information and cooperationE1416
1
Further to a request from—
a
an enforcing authority, where radio equipment has been placed by a manufacturer on the market in the United Kingdom, or
b
a competent national authority, where the radio equipment has been placed by a manufacturer on the market in another F38relevant state,
the manufacturer must, within such reasonable period as the authority may specify, provide the authority concerned with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.
2
A request referred to in paragraph (1)—
a
is one that was made during the period of 10 years beginning on the day that the manufacturer places the radio equipment on the market, and
b
must be accompanied by the reasons for making the request.
3
The information referred to in paragraph (1)—
a
may be provided in electronic form, and
b
must be in a language which can be easily understood by the authority concerned.
4
A manufacturer must, at the request of the authority concerned, cooperate with that authority on any action taken to—
a
evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk),
b
eliminate the risks posed by radio equipment which the manufacturer has placed on the market.
Compliance procedures for series productionE1517
1
A manufacturer must ensure, before placing radio equipment on the market, that procedures are in place to ensure that series production remains in conformity with Part 2.
Compliance procedures for series productionE1617
1
A manufacturer must ensure, before placing radio equipment on the market, that procedures are in place to ensure that series production remains in conformity with Part 2.
2
In doing so, the manufacturer must take adequate account of—
a
any change in radio equipment design or characteristics, and
b
any change in a harmonised standard or in another technical specification by reference to which the EU declaration of conformity was drawn up.
Monitoring18
1
When appropriate, with regard to the risks to the health and safety of end-users presented by radio equipment, a manufacturer must—
a
carry out sample testing of radio equipment manufactured by it which has been made available on the market,
b
investigate complaints that radio equipment manufactured by it is not in conformity with Part 2,
c
keep a register of—
i
complaints that radio equipment is not in conformity with Part 2,
ii
radio equipment which is not in conformity with Part 2, and
iii
radio equipment recalls, and
d
keep distributors informed of any monitoring carried out under this regulation.
2
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.
F1Provision of information on compliance of combinations of radio equipment and software18A
1
In this regulation “product” means a combination of radio equipment and software allowing such radio equipment to be used as intended.
2
The Secretary of State may by regulations make provision requiring a manufacturer of a product to provide the Secretary of State with information on the compliance of the product with the essential requirements.
3
Regulations under paragraph (2) may—
a
specify categories or classes of product for which a manufacturer must provide information on compliance;
b
include requirements as to—
i
the identification of the radio equipment and software intended to be used in combination;
ii
the results of conformity assessment carried out in accordance with regulation 41(conformity assessment procedures);
iii
the form the information must take;
c
make provision for the information on compliance to be made available to the enforcing authorities; and
d
make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.
4
Regulations made under paragraph (2) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.
F1Power to amend R14(2)(b) and specify how information is to be presented18B
1
In this regulation “product” means radio equipment types that fall within categories of radio equipment affected by a low level of compliance with the essential requirements.
2
The Secretary of State may by regulations make provision requiring a manufacturer, before placing a product on the market, to—
a
register information on compliance with the essential requirements; and
b
affix to the product a registration number allocated by the Secretary of State.
3
Regulations made under paragraph (2) may specify—
a
the categories or classes of product in respect of which the manufacturer must register information;
b
that some or, where the Secretary of State considers necessary, all of the technical documentation listed in Schedule 5 must be registered;
c
that when setting out a registration process the Secretary of State must take the following matters into account—
i
whether the process includes a central system of registration by manufacturers;
ii
whether the process ensures appropriate control of access to information of a confidential nature; and
iii
whether the process allocates a registration number to each registered radio equipment type.
4
Regulations made under paragraph (2)—
a
may make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate; and
b
are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.
F1Power to require registration of radio equipment18C
1
The Secretary of State may by regulations—
a
amend regulation 14(2)(b);
b
amend the Implementing Regulation;
c
make provision specifying the manner and form in which information concerning any restrictions or putting into service or requirements for authorisation of use must be presented.
2
Regulations made under paragraph (1)—
a
may make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate; and
b
are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.
Authorised representativesE1719
1
A manufacturer may, by written mandate, appoint a person established F41in the United Kingdom as their authorised representative to perform specified tasks on that manufacturer's behalf.
2
The authorised representative must perform the tasks specified in the mandate.
3
The mandate must allow the authorised representative to do at least the following—
a
perform the manufacturer's obligations under regulation 11 (retention of technical documentation and F42... declaration of conformity),
b
perform the manufacturer's obligations under regulation 16 (provision of information and cooperation).
4
The mandate must not include the obligations contained in—
a
regulation 7 (design and manufacture in accordance with essential requirements),
b
regulation 9 (technical documentation and conformity assessment), or
5
An authorised representative must comply with all the obligations imposed on the manufacturer by these Regulations which relate to the tasks that the authorised representative is appointed by the manufacturer to perform and, accordingly—
a
as far as those obligations are concerned, references in these Regulations to the manufacturer are to be taken as including a reference to the authorised representative, and
b
if the authorised representative contravenes or fails to comply with any of those obligations, the authorised representative may be proceeded against as though the authorised representative was the manufacturer.
6
A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, an obligation under these Regulations remains responsible for the proper performance of that obligation.
Authorised representativesE1819
1
A manufacturer may, by written mandate, appoint a person established within the F45relevant market as their authorised representative to perform specified tasks on that manufacturer's behalf.
2
The authorised representative must perform the tasks specified in the mandate.
3
The mandate must allow the authorised representative to do at least the following—
a
perform the manufacturer's obligations under regulation 11 (retention of technical documentation and EU declaration of conformity),
b
perform the manufacturer's obligations under regulation 16 (provision of information and cooperation).
4
The mandate must not include the obligations contained in—
a
regulation 7 (design and manufacture in accordance with essential requirements),
b
regulation 9 (technical documentation and conformity assessment), or
F49c
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
An authorised representative must comply with all the obligations imposed on the manufacturer by these Regulations which relate to the tasks that the authorised representative is appointed by the manufacturer to perform and, accordingly—
a
as far as those obligations are concerned, references in these Regulations to the manufacturer are to be taken as including a reference to the authorised representative, and
b
if the authorised representative contravenes or fails to comply with any of those obligations, the authorised representative may be proceeded against as though the authorised representative was the manufacturer.
6
A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, an obligation under these Regulations remains responsible for the proper performance of that obligation.