Radio Equipment Regulations

Radio Equipment Regulations

This Guide is designed to help you understand The Radio Equipment Regulations. The purpose of the legislation is to ensure safe products are placed on the GB market by requiring manufacturers to show how their products meet the ‘essential requirements’.

The Regulations regulate the safety and electromagnetic compatibility of radio equipment and promote the protection of the radio spectrum. They require equipment placed on the GB market to comply with a high level of safety (in terms of the health and safety of persons and domestic animals and the protection of property); with an adequate level of electromagnetic compatibility; and to operate in a manner that promotes efficient use of the radio spectrum.

Scope

The UK Radio Equipment Regulations apply to all equipment placed on the market in Great Britain that uses the radio spectrum below 3THz for communication and for radiodetermination. The regulations apply to both transmitters and receivers.

This means that if you manufacture any product that transmits or receives radio frequencies over the air your product will almost certainly be subject to the Regulations.

This includes connected devices such as those that transmit and receive radio signals including WiFi and Bluetooth devices. This could include medical devices, fire detection, and suppression products, or any other products used throughout the built environment.

The Regulations have some notable exceptions. These exceptions include:

Equipment covered by other specific UK legislation governing the conformity of the equipment with the essential requirements;

Airborne products, parts and appliances within the scope of Article 3 of Regulation (EC) 216/2008;

Marine equipment falling within the scope of the Merchant Shipping (Marine Equipment) Regulations 2016; and

Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

Key Definitions

Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. From 1 January 2021, authorised representatives for the GB market must be based in the UK. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.

Declaration of conformity – A document prepared by the manufacturer which must detail the following: The specific radio equipment to which the declaration is referring. The name and address of the manufacturer and, where applicable, their authorised representative. This must be kept by the manufacturer for a period of ten years from the date on which the radio equipment was placed on the GB market. This declaration must be made available to the enforcing authority upon request.

Distributor – Any person in the GB supply chain, other than the manufacturer or the importer, who makes radio equipment available on the GB market.

Enforcing Authority – In Great Britain, for equipment in the use in the workplace, this is the Health and Safety Executive. For products for consumer use this is local trading standards authorities. For nuclear sites in Great Britain, the Office for Nuclear Regulation is the enforcing authority.

Importer - A person established in the UK who places radio equipment from a country outside of the UK on the GB market. This includes a person based in NI who has been supplied with the product from an EEA country, who would, under NI law, be a distributor. A person, who before 1 January 2021 (under EU Rules) distributed radio equipment within the UK or the EU or from Switzerland, is now an importer if they are bringing such equipment into GB from another country (including EU Member States, the EEA or Switzerland).

Manufacturer – A person who manufactures radio equipment, or has radio equipment designed or manufactured, and markets that equipment under their name or trademark.

UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods (including radio equipment) being placed on the GB market, in place of the CE marking which is the conformity marking used in Northern Ireland and the European Union.

UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory third-party conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the Northern Ireland market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying Northern Ireland goods.

Obligations of Manufacturer’s

A manufacturer is a person who manufactures radio equipment, or has radio equipment designed or manufactured, and markets that equipment under their name or trademark.
The obligations of manufacturers of radio equipment include:

1. Before placing radio equipment on the GB market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements and that they have had a relevant conformity assessment procedure carried out and technical documentation drawn up. See regulations 6-9.

2. A manufacturer must ensure that radio equipment has been constructed so that it can be operated without causing an infringement of the applicable requirements of the use of the radio spectrum. See regulation 8.

3. Once this has been done, a manufacturer must draw up a declaration of conformity, and affix the UKCA marking3 to the product. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the equipment. See regulation 10.

4. Qualifying Northern Ireland goods can be placed on the GB market with the CE and CE UKNI conformity markings.

5. Manufacturers must keep the technical documentation and the declaration of conformity for 10 years after the radio equipment has been placed on the GB market. See regulation 11.

6. Manufacturers must also label radio equipment with their name, registered trade name or registered trademark and address; the type batch or serial number (or other identification) and ensure that they are accompanied by instructions and safety information in easily understandable English. Where the size or nature of the equipment prevents the manufacturer from placing this information on the product itself, they may place it on the packaging or in an accompanying document. Manufacturers must, when appropriate with regard to any risk posed to consumers, carry out sample testing of equipment they have placed on the GB market and must investigate any complaints that the electrical equipment is not in conformity with the legal requirements of the 2016 Regulations and keep records of these complaints.

7. When placing radio equipment on the GB market, the manufacturer must ensure that it is accompanied by information concerning any restrictions on putting into service or requirements for authorisation of its use as well as other information. See regulations 12-14.

8. Manufacturers must put procedures in place to ensure that series production remains in conformity with the Regulations. See regulation 17.

9. Manufacturers must, when appropriate, take action to carry out sample testing of equipment made available on the GB market by them which may present a risk, investigate complaints that equipment is not in conformity, keeping a register of such equipment and any complaints or recalls, and keeping distributors informed of any monitoring. Manufacturers must keep an entry on the register for 10 years. See regulation 18.

10. Manufacturers must take action where they have reason to believe that radio equipment they have placed on the GB market is not in conformity with the Regulations. See regulation 15.

11. Manufacturers must also cooperate with and provide information to enforcing authorities following any requests. See regulation 16.

Manufacturers based in Northern Ireland can follow the legislation as it applies to Northern Ireland and place qualifying Northern Ireland goods on the GB market without any additional approvals. However, they will also have to comply with the importer labelling duties (see obligations of importers).

Obligations of Authorised Representatives

Manufacturers are able by written mandate to appoint authorised representatives to perform certain tasks on their behalf.

Mandated authorised representatives for the GB market can be based in GB or Northern Ireland, but after 1 January 2021 cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK, under the 2017 Regulations as they apply in GB.

No GB-based authorised representatives are recognised under EU law. This means GB based authorised representatives cannot carry out tasks on the manufacturer’s behalf for radio equipment being placed on the Northern Ireland or EEA markets. Therefore, a GB manufacturer selling radio equipment to the EEA or into Northern Ireland, who wishes to appoint an authorised representative to carry out tasks for them in respect of that equipment, must appoint an authorised representative based in Northern Ireland or the EEA.

An authorised representative must comply with all the duties imposed on the manufacturer under the 2017 Regulations that they are appointed by the manufacturer to perform. There are some duties that a manufacturer cannot mandate an authorised representative to perform (e.g. conformity assessment) and some that must form part of the authorised representatives mandate (e.g. retention of technical documentation).

A manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf.

Any references in the 2017 Regulations to the manufacturer are to be taken to include a reference to the authorised representative including in relation to penalties for failure to comply with those duties.

Obligations of importers

An importer is a person or business based in the UK who places radio equipment on the GB market from a country outside the UK. This means that UK businesses which used to act as a ‘distributor’ before the end of the transition period legally become an ‘importer’ if they place products from an EEA country on the GB market.

This includes radio equipment that is supplied to NI businesses from the EEA and then placed on the GB market. In this instance the NI business will take on importer obligations for EEA-supplied goods that are placed on the GB market (see also Section 10 on Qualifying Northern Ireland Goods).

Importers have additional legal obligations which go beyond those of distributors, such as checking that manufacturers have carried out the required conformity assessment procedures and including their (the importer’s) name, registered trade name or mark and a postal address on the equipment or, where this is not possible, on its packaging or in accompanying documentation.

To assist with the transition, the UK is applying a transitional period ending on 31 December 2022 to allow UK suppliers of goods from the EEA or Switzerland (who from 1 January 2021 are importers into the GB market) to provide their details on the accompanying documentation as an alternative to placing them on the radio equipment itself. This applies to goods that are not qualifying Northern Ireland goods.

Can you be contacted easily if there is a problem?

A key principle underpinning product safety, for the benefit of consumers and regulators, is traceability of a product back to its source.

In recognition that under the new regulatory arrangements you may have the new status of an importer when placing goods from an EEA state on the GB market for the first time, you may provide your contact details in a document that accompanies the product. This will be allowed until 31 December 2022.

We understand that there may be a period of adjustment to the new arrangements for importer documentation for the GB market, and it may be difficult to provide your details on documentation accompanying each and every individual product.

You may therefore use an alternative method where, for example, your contact information is on a document accompanying a batch of products. This document would then follow each batch of products through the distribution chain. Your contact details must follow each product through the distribution chain, but not necessarily by one document per product. Ultimately, the end-user, each distributor (and a regulator) must be able to access the information.

Methods which enable traceability of the product after the initial batch has been broken up could include:

• The importer address is present in shipping documents.
• The importer address is present on the invoice to the GB customer.
• The importer address is present on the label that is on the outer packaging (“shipper”) in which a number of finished goods are packed (normally customers will receive shippers unless the order is very small so that the shipper has to be opened and split).
• The importer address is included on the EU Declaration of Conformity and/or UK Declaration of Conformity (whichever is relevant for the product in question).

You should work with your distributors to ensure physical documentation does accompany batches of the product as far as possible, and in all cases that there are measures in place to ensure end-users are able to identify the UK importer.

Alongside that, but not as an alternative, you can use your company website to provide more information, access to product details and contact points for retailers, consumers and enforcement bodies.

These options are for a time-limited period only and may not be used after 31 December 2022. You are encouraged to put in place measures to ensure that individual items do carry the importer’s address were required ahead of this date.

The EU does not have any such transitional provision. In the absence of this, equipment being sold from GB to NI or the EU must be labelled with the NI or EU-based importer’s address. For further detail about placing on the NI market please see:

The obligations of importers in the UK include:

1. An importer must not place radio equipment on the GB market unless it conforms with the essential requirements. Before placing radio equipment on the GB market, an importer must ensure that the relevant conformity assessment has been carried out by the manufacturer. See regulations 20 and 21.

2. The importer must ensure the manufacturer has drawn up the technical documentation and a Declaration of Conformity; the radio equipment is UKCA marked4 and is accompanied by the required documents and information regarding the manufacturer. See regulation 21. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the equipment.

3. The importer must keep a copy of the Declaration of Conformity and technical documentation for a period of 10 years after the radio equipment has been placed on the GB market. See regulation 28.

4. Where an importer believes equipment is not in conformity, the importer must not place it on the GB market and, where it presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk. See regulation 22.

5. The importer must provide their name, registered trade name or mark and a postal address at which they can be contacted on the radio equipment. Where the size or nature of the equipment prevents the importer from placing this information on the product itself, they may place it on the packaging or an accompanying document. See regulation 23.

6. The importer must ensure that when placing radio equipment on the GB market, it is accompanied by instructions and safety information that are clear, legible and in easily understandable English. See regulation 24.

7. The importer must ensure that while radio equipment is under their responsibility their storage and transport conditions do not jeopardise their conformity with the essential requirements. See regulation 25.

8. When appropriate, the importer must take action to monitor equipment made available on the GB market by them which may present a risk, keeping a register of such equipment and any complaints or action taken. See regulation 26.

9. The importer must take action where they have reason to believe that the radio equipment that they have placed on the GB market is not in conformity with the 2017 Regulations as amended; including informing the relevant market surveillance authority where there is a risk to the health and safety of people. See regulation 27.

10. The importer must also cooperate with and provide information to enforcing authorities following any requests. See regulation 29.

Qualifying Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may also be placed on the GB market.

Obligations of distributors

UK businesses that were distributors of electrical equipment within the EU single market should now consider whether they are importers from the EU single market and therefore what additional responsibilities they may have. The same applies to distributors of goods from the EEA and Switzerland. A distributor is any person, other than the manufacturer or importer, who makes electrical equipment available on the GB market.

The obligations of distributors include:

1. Before making radio equipment available on the GB market, the distributor must take due care to ensure that it is in conformity with the Regulations. See regulation 30.

2. Before making radio equipment available on the GB market, the distributor must also verify that the radio equipment bears the UKCA marking5 and is accompanied by the required documents as well as by instructions and information concerning the use of radio equipment. The distributor must also make sure that certain obligations on the manufacturer or importer have been complied with. See regulation 31. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the equipment.

3. The distributor must not make radio equipment available on the GB market if they think it is not in conformity with the essential requirements. They must take action where they have reason to believe that the radio equipment that they have made available on the GB market is not in conformity with the Regulations. See regulations 32 and 34.

4. The distributor must ensure that while radio equipment is under their responsibility, its storage and transport conditions does not jeopardise its conformity with the essential health and safety requirements. See regulation 33.

5. The distributor must also cooperate with and provide information to enforcing authorities following any requests. See regulation 35.

Conformity assessment procedures

(1) The manufacturer must perform a conformity assessment of the radio equipment, in all its possible configurations, with a view to meeting the essential requirements.
(2) The conformity assessment must take into account all intended operating conditions.
(3) In relation to the assessment of compliance the conformity assessment must also take into account all reasonably foreseeable conditions.
(4) In relation to the assessment of compliance with regulation one of the following procedures must be used—
(a)internal production control set out in Schedule 2 (conformity assessment module A),
(b)UK-type examination that is followed by the conformity to type based on internal production control set out in Schedule 3 (conformity assessment modules B and C),
(c)conformity based on full quality assurance set out in Schedule 4 (conformity assessment module H).
(5) In relation to the assessment of compliance with regulation 6(2), where the manufacturer has applied harmonised standards, the references of which have been published in the Official Journal, the manufacturer must use one of the procedures in paragraph (4) for the conformity assessment.
(6) In relation to the assessment of compliance with regulation 6(2), where the manufacturer has not applied or has only partly applied harmonised standards, the references of which have been published in the Official Journal, or where harmonised standards do not exist, the manufacturer must use the procedure in either paragraph (4)(b) or paragraph (4)(c).

Self-declaration: (conformity assessment module A),

Manufacturers selling radio equipment on the GB market can affix the new UKCA marking before placing equipment on the GB market. CE marking based on self-declaration of conformity by the manufacturer is still possible until 31 December 2021 for the GB market.
It will also be possible to affix both the UKCA marking and the CE marking to the same equipment on the basis of self-declaration, as long as the EU and GB requirements remain the same. When selling to the EU or supplying to NI, the CE marking remains mandatory

1. Internal production control; is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4 below and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the essential requirements by applying a designated standard.

Technical documentation

2. The manufacturer must establish the technical documentation
The technical documentation produced by the manufacturer for the radio equipment must contain all the relevant data or details of the means used by the manufacturer to ensure that the radio equipment complies with the essential requirements.

(2) The technical documentation in paragraph must contain:
(a) A general description of the radio equipment including—
(i) Photographs or illustrations showing external features, marking and internal layout;
(ii) Versions of software or firmware affecting conformity with the essential requirements;
(iii) User information and installation instructions;
(b) Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;
(c) Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment;
(d) A list of the designated standards applied in full or in part the references of which have been published in the Official Journal, and, where those standards have not been applied, descriptions of the solutions adopted to meet the essential requirements, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation must specify the parts which have been applied;
(e) Copy of the UK declaration of conformity;
(f) Where the conformity assessment module in Schedule 3 (UK-type examination and conformity to type based on internal production control) has been applied, copy of the UK-type examination certificate and its annexes as delivered by the notified body involved;
(g) Results of design calculations made, examinations carried out, and other relevant similar elements;
(h) Test reports;
(i) An explanation of the compliance with the requirement and of the inclusion or not of information on the packaging (information to be included where there are restrictions on putting into service or requirements for authorisation of use).
(a) Contain, at least, the elements set out in the contents of technical documentation,
(b) Be drawn up before the radio equipment is placed on the market, and
(c) Be continuously updated.

3. The technical documentation in paragraph (1) and correspondence relating to any UK-type examination procedure must be drawn up in English and the notified body is established in the UK.

4. Where the technical documentation does not comply with the requirements in paragraphs (1), (2) or (3) and in doing so fails to present sufficient relevant data or details of the means used to ensure compliance of radio equipment with the essential requirements, the market surveillance authority may ask the manufacturer or importer to have a test performed, within a specified period, by a body acceptable to the market surveillance authority, at the expense of the manufacturer or the importer to verify conformity with the essential requirements

Manufacturing

5. The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured radio equipment with the technical documentation referred to in paragraph 2 and with the essential requirements.

UKCA marking and UK declaration of conformity

6.—(1) The manufacturer must affix the UKCA marking to each item of radio equipment that satisfies the applicable requirements of these Regulations.
(2) The manufacturer must draw up a written UK declaration of conformity for each radio equipment type and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The UK declaration of conformity must identify the radio equipment for which it has been drawn up.
(3) A copy of the UK declaration of conformity must be made available to the relevant authorities upon request.

Authorised representatives

7. The manufacturer’s obligations set out in paragraph 4 may be fulfilled by the manufacturer’s authorised representative, on the manufacturer’s behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate.

Approved Bodies

The UK has established a new framework for UK based bodies to assess products against GB rules

UK approved bodies must be established in the UK and be independent of the manufacturer. Approved bodies must examine the technical documentation and supporting evidence in respect of a product to assess the adequacy of the technical design.

Where an approved body finds that essential safety requirements have not been met by a manufacturer, they must not issue a certificate of conformity and they must require the manufacturer to take corrective measures

UKCA Marking

Assessment through third-party organisations: From 1 January 2021, radio equipment that is conformity assessed by a UK approved body should be UKCA marked, not CE marked.
Rules around physically affixing the new UKCA marking mirror those which currently apply for the application of the CE marking, although, until 31 December 2022, the UKCA marking may be affixed to a label affixed to the equipment or a document accompanying the equipment, rather than being affixed to the equipment itself (even where it is otherwise possible to affix it to the equipment itself).

UK Declaration of Conformity

The UK Declaration of Conformity is a document which must be drawn up for most products lawfully bearing a UKCA marking.

In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should:

• declare that the product is in conformity with the relevant statutory requirements applicable to the specific product
• make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)

The UK Declaration of Conformity should be available to market surveillance authorities on request.

The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity.

This can vary depending on the applicable legislation but generally should include:

• your name and full business address or that of your authorised representative
• the product’s serial number, model or type identification
• a statement, stating you take full responsibility for the product’s compliance
• the details of the approved body which carried out the conformity assessment procedure (if applicable)
• the relevant legislation with which the product complies
• your name and signature
• the date the declaration was issued
• supplementary information (if applicable)
You will need to list:
• relevant UK legislation (rather than EU legislation)
• UK designated standards rather than standards cited in the Official Journal of the European Union

The UK standards are currently the same in substance and with the same reference as the standards used in the EU.

HOW WE CAN HELP:

Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.

The CE Marking Authority have a positive attitude and approach regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialise in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations

Our expert team is here to help you meet the UKCA and CE Marking the requirements

• Free initial consultation to assess your requirements and plan the UKCA marking of your product.
• Identify the statutory instruments, the essential safety requirements and designated standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the UK safety regulations.
• Provide a draft UK Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.

The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonisation of your systems