2.8 製造業者の責任の説明

The manufacturer is responsible for designing and manufacturing the product in accordance with essential requirements as set out in Article 3 of the RED.

Article 17 of the RED describes the applicability of each conformity assessment procedure (Annex II, III or IV) with a view to meet the essential requirements set out in Article 3. Manufacturers are free to choose whether or not to apply harmonised standards whose references are published in the Official Journal of the European Union (OJEU) under the RED, however doing so impacts the CAP.

For the essential requirements set out in Article 3 of the RED, Article 17 of the RED provides that conformity shall be demonstrated by using Module A (Annex II of the RED), Module B+C (Annex III of the RED) or Module H (Annex IV of the RED). However, with respect to the requirements set out in Articles 3.2 and 3.3 of the RED, Module B+C (Annex III of the RED) or Module H (Annex IV of the RED) shall be used, if harmonised standards are partially applied or not applied or do not exist.

Hence, for the essential requirements set out in Article 3.1.a, 3.1.b and 3.4 of the RED, the possibility to demonstrate conformity with these essential requirements by means other than using the harmonised standards is not linked to the involvement of a notified body, because the manufacturer has always the discretion to use Module A (Annex II of the RED) which does not involve a notified body.

With respect to the requirements set out in Articles 3.2 and 3.3 of the RED, a conformity assessment involving a notified body shall be used, if such harmonised standards are partially applied or not applied or do not exist, because Module B+C (Annex III of the RED) and Module H (Annex IV of the RED) involve a notified body.

Figure 1: Overview of the different conformity assessment procedures

Figure 2: Flowchart risk assessment

Under the Modules mentioned above, an assessment needs to be carried out to ensure that radio equipment complies with the essential requirements set out in Article 3 of the RED (that includes an assessment of the risks and aspects

covered by Article 3). Based on the wording of Article 21 and Annex V of the RED, this assessment (whether Module A, B+C or H has been followed) shall be included in the technical documentation.

If the conformity assessment procedures require the manufacturer to perform tests, the manufacturer may seek the assistance of a third party (e.g. laboratory), but the manufacturer remains responsible in all cases for the conformity of the radio equipment.

In its conformity assessment, the manufacturer has to “take into account all intended operating conditions” (Article 17 RED). This refers to intended operating conditions that may alter the product behavior with respect to the conformity of the product with the essential requirements. For Article 3.1(a) the assessment shall also take into account the reasonably foreseeable conditions of use.

Where the radio equipment is capable of taking different configurations, the conformity assessment shall confirm whether the radio equipment meets the essential requirements set out in Article 3 in all possible configurations.

Where the radio equipment is of multimode nature, the conformity assessment is limited to the modes that may legally be operated in EU/EEA/EFTA countries.

[footnote on multimode]

The manufacturer shall ensure that the radio equipment placed on the EU market is in conformity. In carrying out this assessment, he may use assessments performed previously for components or parts of that radio equipment, while remaining responsible for the conformity of the whole product.

The reused assessment of the components or parts may not be sufficient to demonstrate conformity of the whole radio equipment.

If assessments performed previously for components or parts are used, these assessments shall be included in its technical documentation. It must be possible to make the technical Documentation available to the market surveillance authorities within the Union. However, there is no obligation to keep it inside the Union. The requirement for making this technical Documentation available does not mean that the person who bears this responsibility has to store it himself, as long as he is capable of presenting it on request from the national authorities.

(see Chapter 7.2 of the Blue Guide).

If the state of the art has changed (e.g. when the applicable hEN has been revised), the manufacturer shall reassess the compliance of his radio product taking in account the changes in the state of the art. Reassessing the compliance doesn’t mean to redo all the tests. The manufacturer has to review the risk assessment and determine the impact on his conformity assessment procedure. The result of analysis has to be included in the technical Documentation.

In addition to the essential requirements, in order to place the equipment on the EU market Article 10.2 of the RED requires manufacturers to ensure that radio equipment can be operated in at least one Member State without infringing

applicable requirements on the use of radio spectrum. This does not imply that it is possible to put the equipment into service or operate it in all Member States.

The requirements on the use of radio spectrum are specified by spectrum management authorities in each EU Member State and reflected in their national frequency allocation plan. Therefore, manufacturers need to check the applicable requirements on the use of the radio spectrum in all EU countries. If restrictions for the use of the equipment are applicable, the necessary information shall be provided with the equipment according to Article 10.10 of the RED. Contact details of EU spectrum management authorities can be found here under “Contact points”:

https://single-market-economy.ec.europa.eu/sectors/electrical-and-electronic- engineering-industries-eei/radio-equipment-directive-red_en

It is noted that, Member States are required, through Article 8 of the RED, to notify radio interfaces which they intend to regulate. This information provides guidance to the manufacturer regarding national spectrum plans and restrictions.

The European Communications Office (ECO) maintains a Frequency Information System (EFIS) where information regarding spectrum use in Europe is made available. This system is accessible here: https://efis.cept.org/. According to recital 24, Member states are to use the Frequency Information System (EFIS) of the European Communications Office (ECO) in order to make comparable information regarding the use of radio spectrum in each Member State available to the public via the internet.

Article 10.3 requires the manufacturer to draw up the Technical Documentation (TD) before placing radio equipment on the EU market. Specific requirements for the TD are contained in Article 21 of the RED.

TD should reflect the whole history of the product and contain all EU-DoC’s, test reports, risk assessment that have been updated and not only the latest version.

The general principles of the TD are specified in Chapter 4.3 of the Blue Guide, this is reflected in Annex V of the RED. There are some elements in Annex V that are only requested by RED:

General description of the product including:

photographs or illustrations showing external features, marking and internal layout

version of software or firmware affecting compliance with essential requirements: the manufacturer has to provide this information only if the

software or firmware has an influence on the conformity of the radio equipment (such as a change of software that would allow operation in a different frequency range or at higher output power). The manufacturer has the responsibility to assess the compliance of the radio equipment, in combination with the embedded software, with the RED. Such assessment shall be properly reflected in the TD.

the manufacturer shall include the user information and installation instructions referred to in Article 10.8 of the RED.

Solutions adopted to meet the essential requirements

The technical conformity of radio equipment must be ensured in accordance with Article 17 of the RED (see Section 2.8 b). The manufacturer may apply harmonised standards listed in the OJEU, which provide presumption of conformity to an essential requirement, or apply any other means to demonstrate compliance with the applicable essential requirement(s). In that case, the manufacturer must include a list of relevant technical specifications applied, and an explanation on how the compliance is reached without (or with partial) application of harmonised standard listed in the OJEU. This way of demonstrating compliance is applicable to all essential requirements, including Articles 3.1(a), 3.1(b) and 3.4.

If the manufacturer referred in the EU-DoC to an hEN with delta’s because the TD does not contain a test report based on this hEN but an older version and an analysis of the delta’s between the old and new version of the hEN then these delta’s have to be explained/documented and the test results have to be added in the TD. If a delta for article 3.2 & 3.3 can be considered as a deviation from the hEN (e.g. different test setup) then a Notified body has to be involved.

If the manufacturer applies a standard that has not been listed in the OJEU for one of the essential requirements, the manufacturer needs to motivate clearly why the radio equipment fulfills applicable essential requirement and why this particular standard can be used for the radio equipment in question.

If the manufacturer has not used a harmonised standard applicable to the radio equipment, then the manufacturer needs to document why the radio equipment still complies with the essential requirement(s) of the RED. The manufacturer has to document for example the test result and explain the alternative test setup.

Compliance with article 3.4 can only be achieved when the manufacturer apply the technical specification detailed in the applicable Commission delegated regulation. The test results of the compliance with that technical specification should be documented.

If applicable, a copy of the EU-type examination certificate and its annexes as delivered by the notified body involved:

If the manufacturer has applied the conformity assessment procedure according to Annex III of the RED, then he has to include “a copy of the EU- type examination certificate and its annexes as delivered by the notified body involved.

copy of the EU-declaration of conformity

a copy of the EU- declaration of conformity has to be included in the TD;

Explanation of the compliance with the requirement of Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10):

The manufacturer has to provide an explanation (such as a statement accompanied by detailed information on the EU/EEA/EFTA countries where the radio equipment may be legally operated and the according NRI [National Radio Interface] declaring that his radio equipment has been constructed so that it can operate in at least one Member State (Article 10.2). Furthermore, he has to provide an explanation about the inclusion of information on potential restrictions of use for the putting into service of the radio equipment (Article 10.10). This could be for example a statement declaring that there are no restrictions of use. In cases where there are restrictions, such statement could for example point to the geographical information provided on the packaging and in the instruction manual.

The manufacturer has to include “an adequate analysis and assessment of the risk(s)” in the TD independently of the CAP applied. Chapter 4.3 of the Blue Guide provides clarification on how such assessment shall be documented.

According Article 21.4 of the RED, in cases where the TD does not comply with the requirements above and consequently fails to provide sufficient relevant data or means used to ensure compliance of radio equipment with the essential requirements of the RED, a market surveillance authority may ask the manufacturer or the importer to have a test performed by a body acceptable to that authority at the expense of the manufacturer or importer in order to verify compliance with the essential requirements of the RED.

According Ar. 25 Regulation (EU) 2025/2509 (Toys Regulation), the safety assessment of toys incorporating radio equipment shall take account of the particular vulnerabilities of children in relation to the use of such toys as intended, when assessing and addressing the hazards that the toy may present.

The general principles of the EU-DoC are set out in the "Blue Guide" (Section 4.4). The following explanations mainly concern specific obligations under the RED.

According to Article 10.3 of the RED the manufacturer is required to issue a EU- DoC where compliance of radio equipment with the applicable requirements of the RED has been demonstrated.

The EU-DoC has to be kept by the manufacturer for 10 years as of the date that the radio equipment was placed on the EU market (to be understood as the last unit of the product model placed on the EU market).

Annex VI of the RED defines the content and the model structure of the EU- DoC. The RED requires under point 8 of this annex to list accessories and components including software which allow the radio equipment to operate as intended. Manufacturers only have to describe those accessories and components including software if they:

(1) have an influence on the conformity of the radio equipment, and

(2) are intended to be installed or changed by the user without the control of the manufacturer.

In those particular cases, the manufacturer can decide the format and the level of description of those pieces of accessories and components including software as long as they can be identified.

Accessories example:

If the radio equipment is delivered without an antenna, then the technical features of the antenna that may be used in conjunction with the radio equipment shall be provided to the user. The user is responsible to operate the radio equipment and the accessories as intended and according to the description provided by the manufacturer.

These technical features of the accessories shall therefore be mentioned in the EU-DoC in order to enable the user to operate a compliant radio equipment. This information could be the generic characteristics of a given antenna type or a reference to a specific antenna(s) available on the EU market.

Software example:

If the radio equipment has software (such as firmware, PC controlling software) that can affect its compliance with the Directive and the manufacturer intends and offers the possibility to the user to freely change it or modify it, then the software shall be named in the EU-DoC so that it is possible for the user to put a compliant radio equipment into operation. The manufacturer can decide the format of the description of this software as long as it can be identified.

On the other hand, if the radio equipment has software that cannot affect its compliance with the Directive, even when the software is modified or replaced, then no information has to be provided in the EU-DoC.

Manufacturers shall not confuse the EU-DoC with other documents as e.g.

conformity certificates from an (accredited) test lab, notified body certificate.

These documents may be easily distinguished: the EU-DoC is signed by the manufacturer or on his behalf by the authorised representative, while the other documents are signed by the test lab or notified body. A EU-DoC shall be only signed by the manufacturer or his authorized representative. The other economic operators cannot sign it because only the manufacturer may ensure the compliance of the product with the essential requirements.

The designation of the radio equipment, in the EU-DoC, has to permit a link between the product, the complete EU-DoC and the technical documentation.

Accompany each radio equipment

A copy of the EU-DoC or a simplified declaration of conformity has to accompany each radio equipment (i.e. at least one of them shall be in printed form). Without prejudice to other specific Union harmonisation which includes the same requirement, the RED does not prohibit the display of the EU-DoC or the simplified EU-DoC, when it accompanies the radio equipment, in such locations as the operating manual, a separate sheet, printed on the radio equipment, or on the packaging.

From 1st January 2026, the EU-DoC has not to accompany the toy incorporating a radio equipemnt when the manufacturer has created a digital product passport according articles 19 and 20 of the Regulation (EU) 2025/2509

Simplified EU-DoC

The wording of the simplified EU-DoC can be found in Annex VII of the Directive.

Some deviation of the wording may be accepted as long as the meaning does not change, as the type designation would be indicated at the top of the page where the simplified EU-DoC text is printed and that the text would refer to it.

The simplified EU-DoC shall indicate the web-address where the complete EU- DoC can be found. This web-address does not necessarily need to directly refer to the document but can lead to a specific Internet address (URL) where the EU-DoC’s are maintained by the manufacturer enabling a simple identification or search for the relevant EU-DoC. Even if the simplified EU-DoC refers only to RED, the complete EU-DoC located on Internet has to refer to all applicable legislation to the radio equipment.

It shall be clarified that the EU-DoC is associated to a product whose conformity has been assessed. If there is a modification of this assessment (due to a new version of the standards or whatever reason), a new EU-DoC has to be issued for the new units of the product. Both of them have to be available online if the manufacturer decides to use the simplified EU-DoC.

The RED prescribes that the description of the intervention of a notified body has to be written in the EU-DoC in its complete form. This means that if a NB has

been involved, the full name of conformity assessment procedure or the module number or the related Annex and the aspects covered shall be specified by referring for example to the related provision.

For maximum common understanding using references as published by the European Commission in the OJEU is highly recommended.

E.g. CENELEC publishes amendments/corrigenda always as separate documents and never uses «+» in its standard references.

When «+» is used (like CEN» it indicates that there is a consolidated edition which includes also the relevant amendment in a single document.

The formatting is available from the OJEU or from the «summary lists» made available on the website of the European Commission: https://single-market- economy.ec.europa.eu/single-market/european-standards/harmonised- standards/radio-equipment_en

The CE marking can take different forms (e.g. colour, solid/hollow) as long as it remains visible, legible and respects the required proportions. Moreover, the RED does not limit the CE marking to physical formats. The CE marking shall be subject to the general principles set out in the "Blue Guide" Chapter 4.5.1.

The following explanations mainly concern specific aspects of the RED.

Article 10.3 of the RED obliges the manufacturer to affix the CE marking to the radio equipment or its data plate when placing a product on the EU market unless this is not possible or not warranted on account of the nature of the radio equipment. This marking shall have a minimum height of 5 mm.

Additionally, the CE marking shall also be affixed visibly and legibly to the packaging.

Furthermore, the Blueguide, in section 4.5.1.4., also specifies that the CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate.

CE marking in the battery compartment does not fulfil the visibility requirement and results in a formal non-compliance. A CE marking in the battery compartment renders the visibility of the CE mark more difficult, as after all, the ‘CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense’ (Recital 29 of Decision 768/08 and Recital 37 of Regulation 765/08). The same is true for any other place where the CE marking would only be visible when something has to be removed such as e.g. the bracelet of a watch, covers, etc

If the nature of the radio equipment does not allow a marking of at least 5 mm, the manufacturer may affix a CE marking that is smaller than 5 mm to the product under the condition that it remains visible and legible. If it not possible or not warranted on account of the nature of the radio equipment to affix a CE marking on the product, the manufacturer may affix it visibly and legibly only to the packaging and, if the product is made available without packaging, it can

be considered good and acceptable practice if the CE marking is provided as separate label (s) or in document (s) accompanying the product.

If the radio equipment is subject to other pieces of EU legislation which do not allow the CE marking to be smaller than 5 mm, then the possibility of using a smaller CE mark cannot be used by the manufacturer (e.g. RoHS).

If a notified body was involved in the conformity assessment procedure according to Annex IV, the CE marking has to be followed by the identification number of the notified body in the same height as the CE marking in accordance with Article 20.3 of the RED. This identification number of the notified body shall be affixed by the notified body itself, or under its instructions by the manufacturer or his authorised representative. This identification number consists of four digits. Unless other pieces of EU legislation give more flexibility

Electronic CE-marking

The application of a CE marking in digital format, if used, can only be done in addition to the physical CE marking. The physical marking has to comply with the rules concerning CE marking including the NB number.

Medical Devices (custom-made)

Under the EU Medical Devices Legislation, custom-made medical devices being placed on the EU market and put into service shall not bear CE marking. If these custom-made medical devices contain radio equipment within the scope of RED and intended to be placed on the EU market, CE marking shall be affixed for the purposes of the RED.

Medical Devices (investigation-study)

Under Article 21 of Regulation 2017/745, investigational medical devices being supplied to an investigator for the purpose of a clinical investigation shall not bear the CE marking (with the exception of the devices referred to in Article 74 of that Regulation).

Under Article 19 of Regulation 2017/746, in vitro diagnostic medical devices for performance study being supplied for that purpose to laboratories or other institutions shall not bear the CE marking (with the exception of the devices referred to in Article 70 of that Regulation).

At this stage, such a device is not placed on the EU market, thus there is no requirement to affix the CE marking on that device even if it consists radio equipment within the scope of the RED. Once the device is intended to be placed on the EU market, it is subject to the requirement of CE marking in accordance with the EU Medical Devices Legislation as well as RED, if it consists of radio equipment within the scope of the RED.

Machinery Directive

Under the Machinery Directive, CE marking is not required for partly completed machinery. The partly completed machinery shall comply with the requirements set out in Article 13 of the MD. If the partly completed machinery contains radio equipment within the scope of the RED and is intended to be placed on the EU market, CE marking shall be affixed for the purposes of the RED.

The new Regulation which will be applicable from 20th January 2027 and will repeal Directive 2006/42/EC with effect from 20th January 2027 will not impact this provision.

Specific cases

Lastly, for specific cases relating to the affixing of CE Marking on tags, see section 1.7.4.15;

According to article 10.6 of the RED, the manufacturer shall ensure that their radio equipment bears a type or batch or serial number or other element allowing its identification.

In cases where the radio equipment is too small or the nature of the equipment does not allow it (if for example the surface of the equipment not suitable for printing), the above information shall be provided on the packaging or in a document accompanying the radio equipment.

Further details about this requirement can be found in Chapter 4.2.2.5 of the Blue Guide.

Lastly, for specific issues relating to tags, see section 1.7.4.15.

Details about this requirement can be found in Article 10.7 of the RED and further explanation in Chapter 4.2.2 of the Blue Guide.

Article 10.7 of the RED requires the name and address of the manufacturer to be present on the product or, under certain conditions, on the packaging or in the accompanying documentation. The name and address of the manufacturer present on the EU-DoC are not sufficient to fulfill the traceability requirement.

Also, for specific cases relating to tags, see section 1.7.4.15.

Traceability information (name and address of the manufacturer and if applicable name and address of the importer does not need to be affixed indelibly, as requested for the CE marking. However, this information should be visible on the product, or on if applicable, the packaging or accompanying document. Meaning that screen protection labels (peel off transparent foil) with traceability information are allowed.

Where restrictions on putting into service or requirements for authorisation for use of radio equipment exist in the Union, Article 10.10 of the RED requires manufacturers to add information on the package that allows the identification of the Member States or the geographical area within a Member State where these restrictions or requirements exist. When the product is made available wihout packaging, it can be considered good and acceptable practice if the pictogram/statement required by the first sentence of Article 10 (10) of the RED is provided as separate label (s) or in document (s) accompanying the product.

In addition, further information on the actual restrictions or requirements shall be completed in the instructions accompanying the radio equipment.

Restrictions on putting into service relate to national frequency allocations, i.e.

frequencies that are not harmonised throughout the whole European Union.

Requirements for authorisation of use relate to individual licencing or conditions attached to authorisation of use (licencing conditions), e.g. indoor/outdoor use or a minimum operation distance from certain protected/restricted areas. Other examples for conditions attached to authorisation of use are the requirements to hold an operator certificate, e.g. radio amateur examination certificate, short range certificate for use of marine VHF-radio.

The Commission adopted an implementing act specifying how to present this information. In particular, the implementing act provides two options on how the information can be presented on the packaging. The manufacturer may either provide, visibly and legibly, a brief written statement or a pictogram on the packaging.

Examples of pictogram (can be in either format):

In addition, the implementing act provides that detailed information shall be provided in the instructions in a language easily understood by end- users as determined by the Member State concerned.

Since 1 February 2020, the United Kingdom (abbreviation: ‘UK’) has withdrawn from the European Union and has become a “third country”. Therefore, with respect to products placed on the EU market as of 1 January 2021:

the reference to United Kingdom and the abbreviation “UK” has no meaning for the purposes of Article 10(10) in EEA;

with respect to Northern Ireland, if there are restrictions on putting into service or any requirements for authorisation of use, as provided for in Article 10 (10), the abbreviation "UK(NI)" shall be used.

Article 10.8 of the RED requires manufacturers to accompany the equipment by instructions and safety information in a language which could be easily understood by consumers and other end- users, as determined by the Member State concerned. Furthermore, they shall be clear, understandable and intelligible.

These instructions shall also include information required to use the radio equipment in accordance with its intended use. In particular, this information shall include, where applicable, a description of accessories and components, including software:

(1) have an influence on the conformity of the radio equipment, and

(2) are intended to be installed or changed by the user without the control of the manufacturer.

Accessories example:

If the radio equipment is delivered without an antenna, then the technical features of the antenna that may be used in conjunction with the radio equipment shall be provided to the user. The user is responsible to operate the radio equipment and the accessories as intended and according to the description provided by the manufacturer.

These technical features of the accessories shall therefore be mentioned in the instruction manual in order to enable the user to operate the compliant radio equipment. This information could be the generic characteristics of a

given antenna type or a reference to a specific antenna(s) available on the EU market.

Software example:

If the radio equipment has software (such as firmware, PC controlling software) that can affect its compliance with the Directive and the manufacturer intends and offers the possibility to the user to freely change it or modify it, then the software should be named in the instruction manual so that it is possible for the user to put a compliant radio equipment into operation. The manufacturer can decide the format of the description of this software as long as it can be identified.

On the other hand, if the radio equipment has software that cannot affect its compliance with the Directive, even when the software is modified or replaced, then no information has to be provided in the EU-DoC.

With the objective of supporting authorities on their market surveillance activities, Article 10.8 of the RED requires manufacturers to accompany radio equipment which intentionally emits radio waves with information on the frequency bands and maximum output power with which the equipment is able to operate in the EU.

Manufacturers have different alternatives to fulfil these requirements. For example, any of the following options could be added to the instructions:

the nominal frequency and transmitted power (radiated and/or conducted) used by the radio equipment, as reflected in the Technical documentation, or

for radio equipment using standardized technologies, e.g. GSM/3G/LTE, indication of the frequency band in the way they are commonly well-known (such as GSM 900, 1800). Where different power levels are possible, the nominal maximum power would be stated.

The «<» symbol or «less than» should not be used to indicate the maximum transmitted power, also reference to power classes is not acceptable.

For multimode equipment the frequency bands and maximum output power must only reflect those for use in the EU.

It is recommended to provide information about the nominal maximum power level expressed in units as it is commonly done in official documents such as Commission decisions, (harmonised) standards, radio interfaces, etc.

For information relating to the common charger that needs to be provided, see Sections 12.2 and 12.3 to this Guide, as well as the Guidance for the interpretation of the Common Charger Directive.

The instructions shall also include detailed information, in a language easily understood by end-users as determined by the Member State, concerning any restrictions on putting into service or requirements for authorisation for use of radio equipment that exist in the EU (Article 10.10 RED).

Format of instructions and safety information

The Blue Guide, in Chapter 3.1.4, provides more details on how the instructions and safety information need to be provided. According to the Blue Guide, whilst the safety information needs to be provided on paper, it is not required that all the set of instructions is also provided on paper but they can also be on electronic or other data storage format, however a paper version should always be available free of charge for the consumers who request it. It is noted that copy of the declaration of conformity (in its simplified or complete form) as the information in Article 10.8 (second sub- paragraph), information in Article 10.10 and information on specifications relating to charging capabilities and the compatible charging devices, as they are specifically required by the RED and not directly related with the general instructions of use, shall be provided in paper.

Note: see Omnibus IV which proposes targeted amendments to several EU legislative texts (including the RED) for introducing digital product information requirements

The manufacturer is responsible for the conformity of every single product manufactured and placed on the EU market. The manufacturer, who places a product on the EU market, shall ensure that, at that particular point in time, the product is in conformity with the applicable legislation.

For series production it is therefore crucial that the manufacturer monitors any changes in hardware/software, developments in applicable standards and legislation and that the state of the art is taken into account adequately. In addition, the considerations given by the manufacturer to these changes shall be reported in the technical Documentation. Details can be found in Chapters 2.3 and 3.1 of the Blue Guide.

Article 10.5 (second sub-paragraph) of the RED obliges the manufacturer to carry out sample tests under certain conditions:

“When deemed appropriate with regard to the risks presented by radio equipment, manufacturers/importers shall, to protect the health and safety of end-users, carry out sample testing of radio equipment made available on the EU market, investigate, and, if necessary, keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, and shall keep distributors informed of any such monitoring.”

In order to protect the health and safety of end users, manufacturers shall fulfil this requirement when the radio equipment presents a risk related to the essential requirement specified in Article 3.1.a.

Further details can be found in Chapter 3.1 of the Blue Guide.

According to Article 10.11 of the RED, in cases where the manufacturer considers or has a reason to believe that radio equipment which he has placed on the EU market is not in conformity with the Directive, the manufacturer shall take immediate corrective actions to:

bring that radio equipment into conformity, or

withdraw it, or

recall it.

In addition, if the manufacturer considers that the radio equipment presents a risk, he shall immediately inform the competent national authorities of the Member States in which they made the radio equipment available on the EU market.

The (post-placing on the EU market) risk assessment referred to in Article 10.11 of the RED is different to the (pre-placing on the EU market) risk assessment required by the RED to be part of the technical Documentation(see section 2.8d).

The risk assessment referred to in Article 10.11 is the one Market Surveillance Authorities would perform in the course of their surveillance activities according to Article 40 of the RED.

Other economic operators also have obligations with regard to the corrective measures.

Corrective actions (e.g. software update) must be documented in the TD. In some cases the EU-DoC has to be updated.

Further details about this requirement can be found in Chapter 3.1 of the Blue Guide.

Manufacturers shall cooperate with competent national authority in the course of their surveillance activities according to Article 10.12 of the RED.

Further details about this requirement can be found in Chapter 3.1 of the Blue Guide.

Radio equipment that is covered by the common charging interface requirements shall be equipped with an USB type C charging receptacle.

In so far as the radio equipment is capable of being recharged by means of wired charging at voltages higher than 5 Volts, currents higher than 3 Amperes or powers higher than 15 Watts, the concerned radio equipment shall incorporate the USB Power Delivery protocol and any additional charging protocol allows for the full functionality of the USB Power Delivery, irrespective of the charging device used.