Radio Equipment Directive (RED) Basics

Many manufacturers have difficulties understanding the RED and its basics. In short we will give a short introduction on the RED that can help you understand and implement the RED.

Scope of the RED

Radio communication and also radio determination equipment
Radio Receivers (including Sound and TV Broadcast receivers)
Safety of humans, animals and property
Equipment operating from 0 – 3000 GHz

What’s not in the scope of the RED

All Telecommunication Terminal Equipment (TTE) as they have no radio function embedded (they are in the EMCD & LVD)
Parts destined for commercial or military air planes
Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes
Equipment used by amateur radio operators
ISM (Industrial, Scientific and Medical) equipment not used for communication
Airborne products, parts and appliances Marine equipment

Notes on the RED

All receivers (including broadcast radio & TV equipment) fall under the scope of the RED.
Cables and Wiring fall under the scope of the RED.
The radio frequency spectrum governed within the scope of the Directive has no lower limit. It was previously from 9KHz up to 3000GHz with the old Directive.
There are no voltage limits for radio equipment.
Many of the descriptive terms from the previous
Directive have been changed or modified. “Radio equipment” now means an electrical product used for Radio communication or Radio determination.
Manufacturers are solely responsible for conformity assessment, and cannot use the conformity procedures laid out in the LVD or EMC Directives to demonstrate compliance, they must use those outlined in the RED.
Mobile phone equipment must be designed to accommodate the use of a common charger.
Radio equipment using special software to enable function must demonstrate compliance of the equipment together with the software.
New versions of software must also prove compliant with the essential requirements.
Radio equipment capable of taking different configurations must undergo conformity assessment in all possible configurations.
CE Marking needs to be on both the product (where possible) and the packaging.
On the product you can now use a CE Mark that is smaller than 5mm providing it is still visible and legible.
Radio equipment must bear the type, model, batch or serial number as well as the name and address of the manufacturer.
Where technical documents do not comply, the surveillance authority may ask the manufacturer or importer to have the product tested by a body accepted by the authority at the expense of the manufacturer or importer.
Compliance documents must be presented to a surveillance authority in a language easily understood by the authority.
The manufacturer must inform the NB of all modifications to the product that may affect compliance.
If re-badging takes place (OEM) the company doing the OEM undertakes all responsibilities of the manufacturer.
Strengthened market surveillance, e.g., the traceability obligations of manufacturers, importers and distributors (NLF).
Clear obligations for manufacturers, importers and distributors (NLF)
Product registration scheme for types of radio equipment within categories affected by low levels of compliance (determined by European Commission by Delegated Act).
No requirement for CE marking in user documentation
Explicit requirements for combinations of radio equipment and software
Technical documentation includes confirmation of operation in at least one Member State without infringing requirements on the use of radio spectrum.
Cannot use the EMC Directive or LVD conformity assessment procedures, the RED only refers to the EMC Directive and LVD to state the essential EMC and Health & Safety requirements
Notified Body identification number must not be used in the CE marking on products which followed the Type Examination procedure.
CE + NB number product marking only for Annex IV FQA (Full Quality Assurance)
NB number must be used in DoC where Type Examination or FQA procedure is followed.
EU legislation applies to individual products. Not to a type of product or series, but to each individual product
EMC and Low Voltage Directives never apply for Radio Equipment, only the essential requirement text in the RED is taken from EMCD and LVD. So do not issue a DOC that references RED + EMCD + LVD! An incorrect DOC is a non-conformity!
CE logo must be on the the product label and packaging (not for EMCD and LVD).
Radio equipment must be accompanied by a copy of the EU DOC or a simplified EU DOC Text (not for EMCD and LVD).
Manufacturers can search in the EFIS (ERO Frequency Information System) and evaluate whether and under which condition their Radio Equipment may be used within each Member State.

Market Access

Art 7: “Member States shall allow the putting into service and use of radio equipment if it complies with this Directive …”
Art 16: “Radio equipment which is in conformity with harmonised standards, shall be presumed to be in conformity with the essential requirements”
Art 17.3 allows the manufacturer to self-declare conformity (“Internal production control”) if Harmonised standards were applied.
Alternatives are available: “EU-type examination” or “conformity based on full quality assurance” both require use of a Notified Body.
The RED requires that where a manufacturer does not make use of Harmonised Standards in their entirety under Articles 3.2 and 3.3 then a Notified Body must be involved with the compliance.
Where a manufacturer does not make use of Harmonised Standards in their entirety under Articles 3.1a, or and 3.1b then they may still self declare (if they wish) but must include a justification why the Standards used meet the state of the art.

Manufacturer obligations

Manufacturers should search EFIS frequency information for band allocation in each Member State before placing on the market.
Draw up technical documentation to show compliance to the directive.
A “Single” DoC shall be drawn up by manufacturer in a language appropriate for the MS.
E-labelling is allowed for devices that have a screen.
Keep technical documentation and DoC for 10 years after the radio equipment has been placed on the market.
If CE mark is placed it shall be capable of operating in at least one Member State!
Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive.
Changes in radio equipment design or characteristics and changes in the harmonized standards or in other technical specifications by reference to which conformity of radio equipment is declared shall be adequately taken into account.
Radio devices need to bear a type, batch or serial number or other element allowing its identification. If the device is too small this information can go on the packaging or user manual.
The device also needs to show the manufacturer name, registered trade name or registered trade mark and the postal address at which they can be contacted. If the device is too small this information can go on the packaging or user manual.
Manufacturers shall ensure that the radio equipment is accompanied by instructions and safety information (freq bands, max RF power transmitted)
Manufacturers shall ensure that each item of radio equipment is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity. Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained.
Manufacturers who consider or have reason to believe that radio equipment which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that radio equipment into conformity, to withdraw it or recall it, if appropriate.

CE Marking

Affiexed only by the manufacturer or his authorised representative.
The CE marking shall be affixed visibly, legibly and indelibly to the radio equipment or to its data plate, unless that is not possible or not warranted on account of the nature of radio equipment.
The CE marking shall also be affixed visibly and legibly to the packaging.
The CE marking shall be affixed before the radio equipment is placed on the market.
On account of the nature of radio equipment, the height of the CE marking affixed to radio equipment may be lower than 5 mm, provided that it remains visible and legitimate.
With the CE marking the manufacturer indicates his responsibility for the product conformity with the essential requirements and its compliance with the RED and other European Union harmonisation legislation.
When several Regulations or Directives apply, the initials CE need to be affixed to the product only once.
The CE marking shall be followed by the identification number of the notified body where the conformity assessment procedure set out in Annex IV is applied.
The identification number of the notified body shall have the same height as the CE marking.
Equipment where the use of its spectrum allocation is not allowed in at least one Member State of Europe, it will be not allowed to make the product available on the EU market. Not complying to this rule, means NO CE mark may be placed on the device as it does not comply to the Directive (European Commission).
Radio equipment types within categories of radio equipment affected by a low level of compliance with the essential requirements are registered within a central system prior to being placed on the market. The Commission shall allocate to each registered radio equipment type a registration number, which manufacturers shall affix on radio equipment besides the CE marking.

Technical File Requirements

A general description (including photographs or illustrations)
Details of firmware or software affecting the compliance of the device
User information and installation instructions
Conceptual design and manufacturing drawings and schema
Descriptions and explanation to understand the drawings
A list of the harmonized standards applied in full or in part, and, where those harmonized standards have not been applied, descriptions of the solutions adopted to meet the essential requirements. Where applied, parts of partly applied harmonized standards should be specified;
A copy of the EU declaration of conformity
EU Type examination certificate (where conformity assessment to ANNEX III has been applied).
Results of design calculations made, examinations carried out, etc.;
Test reports and results
An explanation of the compliance with the requirements of Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10).
- 10(2): Equipment can at least operate in one Member State (MS) without infringing applicable requirements on the use of radio spectrum
- 10(10): Equipment that has restrictions on putting into service or requirements for authorization of use in a MS or within a geographical area of the MS.

Declaration of Conformity

The Declaration of Conformity shall have the structure set out in Annex VI. This document shall be continuously updated as required. It must also be translated into the language or languages required by the member state in which the equipment is made available.
The new contents are as follows:

Identification of object of the declaration, (the radio equipment type, batch and serial number). A color photograph is permissible for clarity
Name and address of the manufacturer or his authorized representative
The statement “This declaration is issued under the sole responsibility of the manufacturer”
It should state: “The object of the declaration described above is in conformity with the relevant Union harmonization Legislation: Directive 2014/53/EU (include other Directives as applicable)”
Reference to the relevant harmonized standards uses or references to other technical specifications used in the assessment (including their identification number and version)
Details of the Notified Body name and number and a description of the assessment they undertook (and the resulting EU type examination certificate)
Descriptions of accessories and software which allow the equipment to function as intended
It should be signed and dated by the responsible person in the organization

Simplified DOC

The simplified Doc is not for EMCD or LVD.
Copy of full EU DoC shall accompany each Radio Equipment.
This may be replaced by a simplified EU DoC.
If a simplified EU DoC is provided, it shall be directly followed by the exact internet or e-mail address where the full EU DoC can be obtained.
It containes the following tekst:
- Hereby, [name of manufacturer] declares that the radio equipment type [designation of type of radio equipment] is in compliance with Directive 2014/53/EU. The full text of the EU DoC is available at the following internet address: ***
It shall be translated into the language(s) required by the Member State in which market the radio equipment is placed.

Conformity assessment procedure

Compliance is against essential requirements, not standards.
However compliance with appropriate Harmonised standards, gives an automatic presumption of compliance with the essential requirements.
There does not need to be a Harmonised standard to apply one of the conformity assessment procedures. The essential requirements apply even in the absence of a Harmonised standard.
The manufacturer shall perform a conformity assessment of the radio equipment with the view of meeting the essential requirements.
If the radio equipment is capable of taking different configurations. The conformity assessment shall confirm whether the radio equipment meets the essential requirements in all possible configurations.

RED instruction manual

Radio Equipment must be accompanied by instructions and safety information in a language which can be easily understood by consumers/end-users. Instructions shall include:

Information on Radio Equipment intended use.
Where applicable, a description of accessories and components, including software, which allow the Radio Equipment to operate as intended.
Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible.
+ (Only for transmitters):
- Frequency band(s) in which the RE operates;
- Maximum radio-frequency power transmitted in the frequency band(s) in which the RE operates.

Geographical information on the packaging

The packaging shall:
– Allow to identify the Member State or the area within a Member State where Radio Equipment cannot be put into service;
– Alert the user to potential restrictions or requirements for authorisation of use in certain Member State.
Such information shall be completed in the instructions accompanying the Radio Equipment.

If a Radio Equipment is subject to restrictions on putting into service, the instructions accompanying the Radio Equipment shall indicate, specifically the geographical area within Member States where restrictions on putting into service exist.

Traceability requirements for Economic operators

Manufacturers & all Importers must indicate the following 3 elements on the product or, where that is not possible, on its packaging or in a document supplied with the product:

Name
Registered trade name/trademark
Postal address at which they can be contacted

Please note that: A website is additional information, but not enough as address. Also note that the address does not necessary mean the address where the manufacturer is located. It can also be the address of the Authorized Representative or of the manufacturer customer services locations.

Manufacturers must also make sure their products bear type, batch, serial or model number allowing their identification. If the size or nature of the product doesn’t allow it, than the required information should be provided on the packaging or in a document accompanying the product.

The identification data on the product, should be the same as stated on the DoC and in the Technical Construction File.

Address on the label/packaging:

A product normally bears 1 or 2 addresses.

A. Manufacturer is in the EU:

Product will bear 1 (manufacturer’s) address as there is no importer involved.

B. Manufacturer is outside the EU and the product is placed on the EU market by an importer:

Product will bear 2 addresses: one of manufacturer and one of the importer.

C. Manufacturer is outside EU and importer puts the product under his own name/ trademark on the EU market:

The importer is then considered the manufacturer. The only address in this case is the address of the importer, who is considered the manufacturer.

D. Manufacturer is in the EU (company in the EU declaring it self manufacturer and puts its address on product), although product is manufactured outside the EU:

That company is considered to be the manufacturer, which places the product on the EU market. Even if actual importation is done by another company. Its sufficient to put only one address, that of the manufacturer.

Risk assessment & Essential requirements

The risks are always related to the essential requirements.

EMCD: risks are only EMC related (creating interference or due to immunity not allowing a product to perform its function correctly)
LVD: risks are only safety related (electrical hazards to humans, domestic animals and property)
RED: risks are Radio related + Safety related (SAR!) + EMC related + other aspects.

Administrative non-compliances are not considered to be a risk.

Manufacturers must:

Carry out a risk analysis to identify all possible risks that the product may pose, and the
Determine the essential requirements applicable to the product.