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Requirements & Application

for

U.S. Conformity Assessment Bodies

Seeking

 EU Radio Equipment Directive (RED) 

2014/53/EU

Notified Body Status 

 

 

For questions related to this document, please send your inquiry to mra@nist.gov.
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Table of Contents 

TABLE OF CONTENTS 2

SECTION 1: INTRODUCTION 3

SECTION 2: REFERENCE DOCUMENTS 5

SECTION 3: APPLICATION PROCESS 6

SECTION 4: ACCREDITATION FOR NOTIFIED BODY ACTIVITIES 7

SECTION 5: ASSESSMENT TOOLS 9

SECTION 6: RED AND NIST REQUIREMENTS FOR NOTIFIED BODIES 11

SECTION 7: TECHNICAL COMPETENCY REQUIREMENTS 25

SECTION 8: NOTIFYING AUTHORITY OBLIGATIONS 26

SECTION 9: MAINTAINING NOTIFIED BODY STATUS 29

SECTION 10: ACCREDITATION BODY REQUIREMENTS 30

SECTION 11: DOCUMENT CONTROL 32

APPENDIX I: NB APPLICATION FORM - RED 35
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Section 1: Introduction

Scope 

This document identifies the requirements for U.S. conformity assessment bodies (CABs) seeking 

Notified Body1status for the EU Radio Equipment Directive (RED) 2014/53/EU - Annex III (Module 

B: EU-Type Examination) only. 

To be designated by NIST to the European Commission for consideration as a Notified Body for 

the Radio Equipment Directive, the applicant CAB shall demonstrate compliance with the 

requirements specified (1) in the Radio Equipment Directive and (2) in this document. 

Notified Body Role

The role of the Notified Body under Module B is to examine a manufacturer’s technical 

documentation and supporting evidence to verify and attest that the technical product design 

meets the relevant legislative requirements. The Notified Body then (1) writes an evaluation 

report (that may be released only upon agreement with the manufacturer), and (2) issues an EUType Examination Certificate. The manufacturer maintains the EU-Type Examination in the 

technical documentation that supports its Declaration of Conformity. 

When the manufacturer is assessing compliance of radio equipment under the essential 

requirements covered by RED Articles 3.1(a), 3.1(b), and 3.4, use of a Notified Body is voluntary. 

When the manufacturer is assessing compliance of radio equipment under the essential 

requirements covered by RED Articles 3.2 and 3.3 and the manufacturer has used harmonized 

standards whose references have been published in the Official Journal of the European Union, 

use of a Notified Body is voluntary. 

When the manufacturer is assessing compliance of radio equipment under the essential 

requirements covered by RED Articles 3.2 and 3.3 and harmonized standards (as published in the 

Official Journal of the European Union) are (a) applied only in part, (2) not applied, or (3) not 

available – the manufacturer is required to use a Notified Body (per RED Article 17.4). 

In the role as Notified Body, the CAB does not test the radio equipment. 

1 A Notified Body (NB) is a third-party conformity assessment body notified to perform specific conformity 

assessment tasks as described in a directive. 
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NIST Role

The United States is a signatory to telecommunication mutual recognition agreements (Tel MRAs) 

with the European Union (EU)2 and the European Economic Area (EEA) European Free Trade 

Association (EFTA) States3. NIST serves as the Notifying Authority4 and is responsible for

designating (notifying) to the European Commission qualified U.S. CABs seeking Notified Body 

status and monitoring on-going compliance of Notified Bodies. 

Exclusions 

The following topics are not addressed in this document:

RED Module H: The requirements for notification to the Radio Equipment Directive Annex IV 

(Module H: Conformity Based on Quality Assurance) are not covered in this document. Notified 

Bodies seeking to be notified for Annex IV should contact NIST at mra@nist.gov. 

RED Module C – RED Annex III also includes Module C: Conformity to Type based on Internal 

Production Control. This module is carried out by the manufacturer. This module relies on the 

EU-Type Examination Certificate provided by the Notified Body. 

EMC Directive: U.S. CABs are eligible to apply for notification as a Notified Body for the 

European Union’s Electromagnetic Compatibility (EMC) Directive (2014/30/EU). The 

requirements and application for EMC NB Status can be viewed on the NIST US-EU MRA 

webpage.

Disclaimers

In the event there is a discrepancy between the contents of this document and the Radio 

Equipment Directive 2014/53/EU (RED), the RED takes precedence.

The hyperlinks included in this document were valid at the time of publication. If a hyperlink is 

broken or no longer points to the correct document, please contact mra@nist.gov for further 

guidance.

NIST reserves the right to change the requirements for application and notification, and to 

update this document as needed to reflect the current interpretations of the RED as issued by 

the European Commission, the Radio Equipment Directive Compliance Association (RED CA), and 

related stakeholder groups. 

2 Agreement on Mutual Recognition Between the European Community and the United States of America 

(Telecommunications Equipment and EMC annexes) – 1998

3 Agreement on Mutual Recognition Between the European Community and the European Economic Area (EEA) 

European Free Trade Association (EFTA) States (Telecommunications Equipment and EMC annexes) – 1998 

4 The Notifying Authority (NA) notifies NBs to the European Commission. There is an appointed NA in each member 

state and in each country that has signed a telecom MRA with the EU. Other MRAs utilize the term Designating 

Authority. 
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Section 2: Reference Documents

The CAB shall maintain (or have access to) the following documents:

Blue Guide5- on Implementation of EU Product Rules (2022) – June 29, 2022

EA 2/17 M:2020 – European Cooperation for Accreditation (EA) Document on Accreditation for 

Notification Purposes (published April 17, 2020, effective April 17, 2021).

Radio Equipment Directive6 2014/53/EU 

Directive (EU) 2022/2380 of the European Parliament and of the Council of 23 November 2022

(introduces the new RED Article 3.4 (common charger) and RED Annex Ia

Guide to the Radio Equipment Directive 2014/53/EU7(December 2018)

Technical Guidance Notes from the Radio Equipment Directive Compliance Association- RED CA8

Summary List of Harmonized Standards applicable for the RED9

EMCD: 

Electromagnetic Compatibility Directive10 2014/30/EU

Guide for the EMC Directive 2014/30/EU11 (December 2018)

Technical Guidance Notes issued by the Notified Body Group for the EMC Directive (EUANB)

12

LVD: Low Voltage Directive13 2014/35/EU 

5 https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=uriserv%3AOJ.C_.2022.247.01.0001.01.ENG&toc=OJ%3AC%3A2022%3A247%3ATOC

6 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2014_153_R_0002&from=EN%20

7 https://ec.europa.eu/docsroom/documents/29782

8 http://www.redca.eu/Pages/Documents%201.htm

9 https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/red_en

10 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2014_096_R_0079_01&qid=1396511671603&from=EN

11 https://ec.europa.eu/docsroom/documents/28323

12 http://www.redca.eu/Pages/Documents3.htm

13 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2014_096_R_0357_01&from=EN
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Section 3: Application Process

The CAB shall obtain accreditation in accordance with the requirements included in Section 4, 

Accreditation for Notified Body Activities. 

The CAB shall also submit the NB Application Form (refer to Appendix I) and the supporting 

documents to NIST at mra@nist.gov. 

The CAB’s supporting documents, including policies and procedures, shall contain the CAB’s 

unique information on how the requirements contained in the Radio Equipment Directive are 

being met by the CAB through specific references and adequate detail. 

NIST will review CAB application documents in the order in which they are received. 

If the supporting documents are incomplete and/or do not address all requirements, NIST will 

notify the CAB of the elements that still need to be addressed and will place the application on 

hold until additional information is provided.

NIST will process a notification to the European Commission for qualified accredited organizations. 

The European Commission conducts a review of all notifications. 

A CAB becomes a RED Notified Body only once the information on the Notified Body’s name 

and the tasks for which the Notified Body has been notified are published 

on the public 

New Approach Notified and Designated Organizations (NANDO) website: 

http://ec.europa.eu/growth/toolsdatabases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=154428

CABs that successfully obtain Notified Body status must continue to meet the requirements of 

the Radio Equipment Directive and this document. 

A periodic renewal of the notification is required. Refer to Section 9, Maintaining Notified Body 

Status.
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Section 4: Accreditation for Notified Body Activities

The CAB shall obtain formal accreditation for its Notified Body activities. 

Acceptable Accreditation Bodies

NIST maintains a list of U.S. accreditation bodies (ABs) that have been evaluated to ensure that 

the assessment and accreditation process meets requirements to support the accreditation of 

Notified Bodies for the purposes of notification. Refer to Section 10, Accreditation Body 

Requirements. 

CABs shall use an accreditation body included on the NIST list of U.S. accreditation bodies 

acceptable for Notified Body accreditation for the purposes of notification. 

ISO/IEC 17065 or ISO/IEC 17020 Accreditation

CABS accredited to ISO/IEC 17065 or ISO/IEC 1702014 that wish to seek NB status can apply to 

NIST under the process covered in RED Article 29.2. The notification process is simplified, with 

minimal information having to be forwarded to the European Commission. 

Effective April 17, 2023 (3 years after publication of EA 2/17 M:2020), only ISO/IEC 17065 

accreditation will be accepted by NIST for the purposes of NB notification. Effective April 17, 

2023, ISO/IEC 17020 accreditation will no longer be accepted. 

European Commission Decision Timeframe: 60 days

Once NIST submits a notification to the EC, there is a sixty day “stand-still” period during which 

Member States can comment on the notification. If no objections are received from Member 

States, and any inquiries from Member States are resolved, the NB status will be approved via 

publication of the NB information on the public NANDO website. 

The 60 day “stand-still period” is based on the terms of the US-EU MRA (not the RED). 

Sequential Notifications Required for New NBs (60 days for each)

When a CAB is applying as an NB for the first time, the notification to the European Commission 

can only be for one Directive. Therefore, CABs applying concurrently for RED and EMCD NB 

status will be asked to select the order of NIST notification to the European Commission. The 

notification for the second Directive can only be made once the first notification process is 

completed (for a total time period of least 120 days to obtain NB status for both the EMCD and 

the RED).

14 NIST acceptance of ISO/IEC 17020 accreditation for NBs ends as of April 17, 2023. 
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Technical Competency Assessment

The technical competency assessment of NBs is the same regardless of the basic conformity 

assessment standards used. 

The technical assessment will include use of the NIST NB Assessment Checklist – RED and

consideration of the information in the RED Assessment Guide.

The technical assessment will include use of the NIST NB Assessment Checklist for Articles 3.3g 

(mobile Phones/Galileo) if the NB is seeking accreditation and will offer NB services for this 

essential requirement. 

The technical assessment will include use of the NIST NB Assessment Checklist for RED Article 

3.4 (common charger) if the NB is seeking accreditation and will offer NB services for this 

recently activated essential requirement.

Scope of Accreditation

The CAB’s Scope of Accreditation shall cover the Notified Body activities. 

NBs are required to following the Scope of Accreditation format/content requirements as 

specified in the most current version of this NIST document (latest version): 

NIST Scopes of the EU and UK Regulatory Schemes Covered under the TEL MRAs - The CAB’s 

ISO/IEC 17065 Scope of Accreditation – Mandatory and Optional Content. 
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Section 5: Assessment Tools

 RED Assessment Guide

NIST NB Assessment Checklist (RED)

NIST NB Assessment Checklist – RED Article 3.3g (mobile phones/Galileo)

NIST NB Assessment Checklist – RED Article 3.4 (common charger)

RED Notified Body Accreditation/Notification Assessment Guide Document

The Radio Equipment Directive Compliance Association, in conjunction with UKAS, has 

developed an RED Assessment Guide15 that identifies the key requirements that Notified Bodies 

shall meet and the types of questions/topic areas that an assessor might cover. It also includes 

the generally accepted areas of knowledge and technical competency that Notified Body 

personnel should be able to demonstrate.

The key technical areas of knowledge included in the RED Assessment Guide are included in 

Section 7, Technical Competency Requirements.

NIST NB Assessment Checklist

NIST has developed a companion NB Assessment Checklist - RED that contains (1) the RED 

normative requirements and (2) any additional NIST requirements applicable to the Notified 

Bodies. This is blank checklist. All questions and guidance included in the RED Assessment Guide 

(described above) have been removed. NIST’s additional requirements have been added.

The NIST NB Assessment Checklist – RED follows the same format as the RED Assessment Guide

wherever possible for ease of use and comparison by CABs and Assessors.

Accreditation Bodies shall use the NIST NB Assessment Checklist - RED to document the 

compliance information obtained during the on-site assessment.

NIST NB Assessment Checklist – RED Article 3.3g (mobile phones/Galileo)

In early 2023, NIST developed an assessment checklist for RED Article 3.3g (mobile 

phones/Galileo). A technical guidance Q&A document has been provided to the assessors, and 

the list of example assessment questions is available to NBs upon request. 

15 RED Notified Body Accreditation/Notification Assessment Guide Document (v1.0c)
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Accreditation Bodies shall use the NIST NB Assessment Checklist - RED Article 3.3g to document 

the compliance information obtained during the on-site assessment.

NIST NB Assessment Checklist – RED Article 3.4g (common charger)

In early 2023, NIST developed an assessment checklist for RED Article 3.4 (common charger). 

Accreditation Bodies shall use the NIST NB Assessment Checklist - RED Article 3.4 (common 

charger) to document the compliance information obtained during the on-site assessment.
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Section 6: RED and NIST Requirements for Notified Bodies

The articles and annexes of the Radio Equipment Directive that are specific to Notified Bodies 

have been reproduced (presented in order in which these appear in the RED16). In some cases, it 

has been necessary for NIST to specify an additional requirement or to clarify an article. These 

requirements are reproduced in the NIST NB Assessment Checklist. 

=====================================================================

RED ARTICLE 3 

Essential Requirements 

NIST Requirement: The CAB shall demonstrate appropriate knowledge of all essential 

requirements in Article 3 – for those essential requirements that are activated.

1. Radio equipment shall be constructed so as to ensure:

(a) the protection of health and safety of persons and of domestic animals and the protection of 

property, including the objectives with respect to safety requirements set out in Directive 

2014/35/EU, but with no voltage limit applying; 

(b) an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU. 

2. Radio equipment shall be so constructed that it both effectively uses and supports the 

efficient use of radio spectrum in order to avoid harmful interference. 

3. Radio equipment within certain categories or classes shall be so constructed that it complies 

with the following essential requirements: 

(a) Radio equipment interworks with accessories other than the charging devices for the 

categories or classes of radio equipment, specified in Part I of Annex Ia, which are specifically 

referred to in paragraph 4 of this Article;

(b) radio equipment interworks via networks with other radio equipment; 

(c) radio equipment can be connected to interfaces of the appropriate type throughout the 

Union; 

(d) radio equipment does not harm the network or its functioning nor misuse network resources, 

thereby causing an unacceptable degradation of service; 

(e) radio equipment incorporates safeguards to ensure that the personal data and privacy of the 

user and of the subscriber are protected; 

16 As amended by Directive (EU) 2022/2380 of the European Parliament and of the Council of 23 November 2022; 
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(f) radio equipment supports certain features ensuring protection from fraud; 

(g) radio equipment supports certain features ensuring access to emergency services;

(h) radio equipment supports certain features in order to facilitate its use by users with a 

disability; 

(i) radio equipment supports certain features in order to ensure that software can only be 

loaded into the radio equipment where the compliance of the combination of the radio

equipment and software has been demonstrated. 

The Commission shall be empowered to adopt delegated acts in accordance with Article 44 

specifying which categories or classes of radio equipment are concerned by each of the 

requirements set out in points (a) to (i) of the first subparagraph of this paragraph.

3.4. Radio equipment falling within the categories or classes specified in Part I of Annex Ia shall 

be so constructed that it complies with the specifications relating to charging capabilities set out 

in that Annex for the relevant category or class of radio equipment.

With respect to radio equipment capable of being recharged by means of wired charging, the 

Commission is empowered to adopt delegated acts in accordance with Article 44 to amend Part I 

of Annex Ia in the light of scientific and technological progress or market developments in order 

to ensure a minimum common interoperability between radio equipment and its charging 

devices, as well as to improve consumer convenience, to reduce environmental waste and to 

avoid market fragmentation, by:

(a) modifying, adding or removing categories or classes of radio equipment;

(b) modifying, adding or removing technical specifications, including references and 

descriptions, in relation to the charging receptacle(s) and charging communication 

protocol(s), for each category or class of radio equipment concerned.

The Commission shall continuously assess market developments, market fragmentation and 

technological progress with a view to identifying categories or classes of radio equipment 

capable of being recharged by means of wired charging for which the inclusion in Part I of Annex 

Ia would lead to significant consumer convenience and reduction of environmental waste.

The Commission shall submit a report on the assessment referred to in the third subparagraph 

to the European Parliament and to the Council, for the first time by 28 December 2025 and 

every 5 years thereafter, and shall adopt delegated acts pursuant to the second subparagraph, 

point (a), accordingly.
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With respect to radio equipment capable of being recharged by means other than wired 

charging, the Commission is empowered to adopt delegated acts in accordance with Article 44 in 

order to amend Part I of Annex Ia in the light of scientific and technological progress or market 

developments in order to ensure a minimum common interoperability between radio equipment 

and its charging devices, as well as to improve consumer convenience, to reduce environmental 

waste and to avoid market fragmentation, by:

(a) introducing, modifying, adding or removing categories or classes of radio equipment;

(b) introducing, modifying, adding or removing technical specifications, including references 

and descriptions, in relation to charging interface(s) and charging communication 

protocol(s), for each category or class of radio equipment concerned.

The Commission shall, in accordance with Article 10(1) of Regulation (EU) No 1025/2012, and by 

28 December 2024, request one or more European standardization organizations to draft 

harmonized standards laying down technical specifications for the charging interface(s) and 

charging communication protocol(s) for radio equipment capable of being recharged by means 

other than wired charging. In accordance with the procedure laid down in Article 10(2) of 

Regulation (EU) No 1025/2012, the Commission shall consult the committee set up under Article 

45(1) of this Directive. The requirements as to the content of the requested harmonized 

standards shall be based on an assessment carried out by the Commission of the current state of 

wireless charging technologies for radio equipment, covering in particular market developments, 

market penetration, market fragmentation, technological performance, interoperability, energy 

efficiency and charging performance.

When preparing the delegated acts referred to in this Article with respect to radio equipment 

capable of being recharged by means of wired charging, as well as with respect to radio 

equipment capable of being recharged by means other than wired charging, the Commission 

shall take into account the degree of market acceptance of the technical specifications under 

consideration, the resulting consumer convenience and the extent of the reduction of 

environmental waste and market fragmentation that can be expected from such technical 

specifications. Technical specifications that are based on relevant available European or 

international standards shall be deemed to meet the objectives set out in the previous sentence. 

However, where such European or international standards do not exist, or where the 

Commission determines, based on its technical assessment, that they do not meet those 

objectives in an optimal manner, the Commission may set out other technical specifications 

which better meet those objectives.
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3.a. - Possibility for consumers and other end-users to acquire certain categories or classes of 

radio equipment without a charging device

1. Where an economic operator offers to consumers and other end-users the possibility to 

acquire the radio equipment referred to in Article 3(4) together with a charging device, 

the economic operator shall also offer the consumers and other end-users the possibility 

of acquiring that radio equipment without any charging device.

2. Economic operators shall ensure that the information on whether or not a charging 

device is included with the radio equipment referred to in Article 3(4) is displayed in a 

graphic form using a user-friendly and easily accessible pictogram as set out in Part III of 

Annex Ia when such radio equipment is made available to consumers and other endusers. The pictogram shall be printed on the packaging or affixed to the packaging as a 

sticker. When the radio equipment is made available to consumers and other end-users, 

the pictogram shall be displayed in a visible and legible manner and, in the case of 

distance selling, close to the price indication.

The Commission is empowered to adopt delegated acts in accordance with Article 44 in order to 

amend Part III of Annex Ia as a consequence of amendments to Parts I and II of that Annex, or as 

a consequence of future amendments to labelling requirements, or in the light of technological 

progress, by introducing, modifying, adding or removing any graphic or textual elements.

 

RED ARTICLE 10 

(Excerpt from list of OBLIGATIONS OF MANUFACTURERS) 

NIST Requirement: The CAB shall demonstrate their understanding of the following 

manufacturer obligations. 

.....

2. Manufacturers shall ensure that radio equipment shall be so constructed that it can be 

operated in at least one Member State without infringing applicable requirements on the use of 

radio spectrum.

....

8. Manufacturers shall ensure that the radio equipment is accompanied by instructions and 

safety information. Instructions shall include the information required to use radio equipment in 

accordance with its intended use. Such information shall include, 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.
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The following information shall also be included in the instructions in the case of radio 

equipment intentionally emitting radio waves:

(a) frequency band(s) in which the radio equipment operates;

(b) maximum radio-frequency power transmitted in the frequency band(s) in which the radio 

equipment operates.

In the case of radio equipment referred to in Article 3(4), the instructions shall contain 

information on the specifications relating to the radio equipment’s charging capabilities and the 

compatible charging devices, as set out in Part II of Annex Ia. In addition to being included in the 

instructions, when the manufacturers make such radio equipment available to consumers and 

other end-users, the information shall be also displayed on a label, as set out in Part IV of Annex 

Ia. The label shall be printed in the instructions and on the packaging or affixed to the packaging 

as a sticker. In the absence of packaging, the sticker with the label shall be affixed to the radio 

equipment. When the radio equipment is made available to consumers and other end-users, the 

label shall be displayed in a visible and legible manner and, in the case of distance selling, close 

to the price indication. Where the size or nature of the radio equipment does not allow 

otherwise, the label may be printed as a separate document accompanying the radio equipment.

The instructions and safety information referred to in the first, second and third subparagraphs 

of this paragraph shall be in a language which can be easily understood by consumers and other 

end-users, as determined by the Member State concerned.

The Commission is empowered to adopt delegated acts in accordance with Article 44 in order to 

amend Parts II and IV of Annex Ia, as a consequence of amendments to Part I of that Annex, or as 

a consequence of future amendments to labelling requirements, or in the light of technological 

progress, by introducing, modifying, adding or removing any details in relation to the 

information, graphic or textual elements, as set out in this Article.

.....

10. In cases of restrictions on putting into service or of requirements for authorization of use, 

information available on the packaging shall allow the identification of the Member States or the 

geographical area within a Member State where restrictions on putting into service or 

requirements for authorization of use exist. Such information shall be completed in the 

instructions accompanying the radio equipment. 

.....

 

 

 
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RED ARTICLE 20 

(Excerpt from CE Marking Requirements) 

......

3.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.

NIST Requirements: The CAB shall be aware of when the NB number should be applied 

to the label. The NB number shall not be applied to the label under Module B.

RED ARTICLE 26 

Requirements Relating to Notified Bodies 

1. For the purposes of notification, a conformity assessment body shall meet the requirements 

laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under national law of a Member State and 

have legal personality.

NIST Requirement: U.S. CAB seeking notification as an NB shall be a legal entity in the 

United States. 

3. A conformity assessment body shall be a third-party body independent of the organization or 

the radio equipment it assesses. A body belonging to a business association or professional 

federation representing undertakings involved in the design, manufacturing, provision, assembly, 

use or maintenance of radio equipment which it assesses may, on condition that its 

independence and the absence of any conflict of interest are demonstrated, be considered such 

a body. 

4. A conformity assessment body, its top level management and the personnel responsible for 

carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, 

installer, purchaser, owner, user or maintainer of the radio equipment which they assess, nor the 

representative of any of those parties. This shall not preclude the use of assessed radio 

equipment that is necessary for the operations of the conformity assessment body or the use of 

such radio equipment for personal purposes. 

A conformity assessment body, its top level management and the personnel responsible for 

carrying out the conformity assessment tasks shall not be directly involved in the design, 

manufacture or construction, the marketing, installation, use or maintenance of that radio 

equipment, or represent the parties engaged in those activities. They shall not engage in any 

activity that may conflict with their independence of judgment or integrity in relation to 
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conformity assessment activities for which they are notified. This shall in particular apply to 

consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or 

subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity 

assessment activities. 

5. Conformity assessment bodies and their personnel shall carry out the conformity assessment 

activities with the highest degree of professional integrity and the requisite technical 

competence in the specific field and shall be free from all pressures and inducements, 

particularly financial, which might influence their judgment or the results of their conformity 

assessment activities, especially as regards persons or groups of persons with an interest in the 

results of those activities.

6. A conformity assessment body shall be capable of carrying out all the conformity assessment 

tasks assigned to it by Annexes III and IV in relation to which it has been notified, whether those 

tasks are carried out by the conformity assessment body itself or on its behalf and under its 

responsibility. At all times and for each conformity assessment procedure and each kind or 

category of radio equipment in relation to which it has been notified, a conformity assessment 

body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the 

conformity assessment tasks; 

(b) descriptions of procedures in accordance with which conformity assessment is carried out, 

ensuring the transparency and the ability of reproduction of those procedures. It shall have 

appropriate policies and procedures in place that distinguish between tasks it carries out as a 

notified body and other activities; 

(c) procedures for the performance of activities which take due account of the size of an 

undertaking, the sector in which it operates, its structure, the degree of complexity of radio 

equipment technology in question and the mass or serial nature of the production process. 

A conformity assessment body shall have the means necessary to perform the technical and 

administrative tasks connected with the conformity assessment activities in an appropriate 

manner. 

7. The personnel responsible for carrying out conformity assessment tasks shall have the 

following: 

(a) sound technical and vocational training covering all the conformity assessment activities in 

relation to which the conformity assessment body has been notified; 

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate 

authority to carry out those assessments; 
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(c) appropriate knowledge and understanding of the essential requirements set out in Article 3, 

of the applicable harmonized standards and of the relevant provisions of Union harmonization

legislation and of national legislation; 

(d) the ability to draw up EU-type examination certificates or quality system approvals, records 

and reports demonstrating that assessments have been carried out. 

8. The impartiality of the conformity assessment bodies, their top level management and of the 

personnel responsible for carrying out the conformity assessment tasks shall be guaranteed. The 

remuneration of the top level management and personnel responsible for carrying out the 

conformity assessment tasks of a conformity assessment body shall not depend on the number 

of assessments carried out or on the results of those assessments. 

9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by 

the State in accordance with national law, or the Member State itself is directly responsible for 

the conformity assessment. 

NIST Requirement: The Notified Body shall have professional liability insurance or errors 

and omissions insurance in an amount that is sufficient in coverage to protect the NB 

from lawsuits arising from its activities and shall provide NIST with continued objective 

evidence that this insurance is maintained.

10. The personnel of a conformity assessment body shall observe professional secrecy with 

regard to all information obtained in carrying out their tasks under Annexes III and IV or any 

provision of national law giving effect to them, except in relation to the competent authorities of 

the Member State in which its activities are carried out. Proprietary rights shall be protected. 

11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible 

for carrying out the conformity assessment tasks are informed of, the relevant standardization

activities, the regulatory activities in the area of radio equipment and frequency planning, and 

the activities of the notified body coordination group established under the relevant Union 

harmonization legislation and shall apply as general guidance the administrative decisions and 

documents produced as a result of the work of that group.

NIST Requirement: The CAB (or one of its related bodies located in the United States) 

shall maintain membership in the Radio Equipment Compliance Association (RED CA). 

RED ARTICLE 28 

Subsidiaries of and subcontracting by notified bodies 

1. Where a notified body subcontracts specific tasks connected with conformity assessment or 

has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the 

requirements set out in Article 26 and shall inform the notifying authority accordingly. 
Version 6.0 (01/30/2023) RED Page 19 of 38

2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or 

subsidiaries wherever these are established. 

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the

client.

4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents 

concerning the assessment of the qualifications of the subcontractor or the subsidiary and the 

work carried out by them under Annexes III and IV.

 

RED ARTICLE 34 

Operational obligations of notified bodies 

1. Notified bodies shall carry out conformity assessments in accordance with the conformity 

assessment procedures provided for in Annexes III and IV.

2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary 

burdens for economic operators. Conformity assessment bodies shall perform their activities 

taking due account of the size of an undertaking, the sector in which it operates, its structure, 

the degree of complexity of the radio equipment technology in question and the mass or serial 

nature of the production process. In so doing they shall nevertheless respect the degree of rigor 

and the level of protection required for the compliance of the radio equipment with this 

Directive. 

3. Where a notified body finds that the essential requirements set out in Article 3 or 

corresponding harmonized standards or other technical specifications have not been met by a 

manufacturer, it shall require that manufacturer to take appropriate corrective measures and 

shall not issue an EU-type examination certificate or a quality system approval. 

4. Where, in the course of the monitoring of conformity following the issue of an EU-type 

examination certificate or a quality system approval, a notified body finds that radio equipment 

no longer complies, it shall require the manufacturer to take appropriate corrective measures 

and shall suspend or withdraw the EU-type examination certificate or the quality system 

approval if necessary. 

5. Where corrective measures are not taken or do not have the required effect, the notified 

body shall restrict, suspend or withdraw any EU-type examination certificates or quality system 

approvals, as appropriate.

 

 

 
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RED ARTICLE 36 

Information obligation on notified bodies 

1. Notified bodies shall inform the notifying authority of the following: 

(a) any refusal, restriction, suspension or withdrawal of an EU-type examination certificate or a 

quality system approval in accordance with the requirements of Annexes III and IV; 

(b) any circumstances affecting the scope of or conditions for notification; 

(c) any request for information which they have received from market surveillance authorities 

regarding conformity assessment activities; 

(d) on request, conformity assessment activities performed within the scope of their notification 

and any other activity performed, including cross-border activities and subcontracting.

2. Notified bodies shall, in accordance with the requirements of Annexes III and IV, provide the 

other bodies notified under this Directive carrying out similar conformity assessment activities 

covering the same categories of radio equipment with relevant information on issues relating to 

negative and, on request, positive conformity assessment results. 

3. Notified bodies shall fulfil information obligations under Annexes III and IV. 

RED ARTICLE 38 

Coordination of notified bodies 

The Commission shall ensure that appropriate coordination and cooperation between bodies 

notified under this Directive are put in place and properly operated in the form of a sectoral 

group of notified bodies. 

Member States shall ensure that the bodies notified by them participate in the work of that 

group, directly or by means of designated representatives. 

NIST Comment: Refer to additional NIST Requirement under Article 26.11 – membership 

in the REDCA is required.

RED ANNEX Ia17 

SPECIFICATIONS AND INFORMATION RELATING TO CHARGING APPLICABLE TO CERTAIN CATEGORIES OR 

CLASSES OF RADIO EQUIPMENT

NIST Requirement: NBs must be knowledgeable about the specific content of Annex Ia if 

providing NB services for RED Article 3.4 (common charger).

17 As introduced with by Directive (EU) 2022/2380 of the European Parliament and of the Council of 23 November 

2022 and new RED Article 3.4 (common charger)
Version 6.0 (01/30/2023) RED Page 21 of 38

RED Annex III 

Module B: EU-type examination 

1. EU-type examination is the part of a conformity assessment procedure in which a notified 

body examines the technical design of the radio equipment and verifies and attests that the 

technical design of the radio equipment meets the essential requirements set out in Article 3. 

2. EU-type examination shall be carried out by assessment of the adequacy of the technical 

design of the radio equipment through examination of the technical documentation and 

supporting evidence referred to in point 3, without examination of a specimen (design type). 

3. The manufacturer shall lodge an application for EU-type examination with a single notified 

body of his choice. The application shall include: 

(a) the name and address of the manufacturer and, if the application is lodged by the authorized 

representative, his name and address as well; 

(b) a written declaration that the same application has not been lodged with any other notified 

body; 

(c) the technical documentation. The technical documentation shall make it possible to assess 

the radio equipment's conformity with the applicable requirements of this Directive and shall 

include an adequate analysis and assessment of the risk(s). The technical documentation shall 

specify the applicable requirements and cover, as far as relevant for the assessment, the design, 

manufacture and operation of the radio equipment. The technical documentation shall contain, 

wherever applicable, the elements set out in Annex V;

(d) the supporting evidence for the adequacy of the technical design solution. That supporting 

evidence shall mention any documents that have been used, in particular where the relevant 

harmonized standards have not been applied or have not been fully applied. The supporting 

evidence shall include, where necessary, the results of tests carried out in accordance with other 

relevant technical specifications by the appropriate laboratory of the manufacturer, or by 

another testing laboratory on his behalf and under his responsibility. 

4. The notified body shall examine the technical documentation and supporting evidence to 

assess the adequacy of the technical design of the radio equipment. 

5. The notified body shall draw up an evaluation report that records the activities undertaken in 

accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in 

point 8, the notified body shall release the content of that report, in full or in part, only with the 

agreement of the manufacturer. 

6. Where the type meets the requirements of this Directive that apply to the radio equipment 

concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. 

That certificate shall contain the name and address of the manufacturer, the conclusions of the 
Version 6.0 (01/30/2023) RED Page 22 of 38

examination, the aspects of the essential requirements covered by the examination, the 

conditions (if any) for its validity and the necessary data for identification of the assessed type. 

The EU-type examination certificate may have one or more annexes attached. 

The EU-type examination certificate and its annexes shall contain all relevant information to 

allow the conformity of manufactured radio equipment with the examined type to be evaluated 

and to allow for in-service control. Where the type does not satisfy the applicable requirements 

of this Directive, the notified body shall refuse to issue an EU-type examination certificate and 

shall inform the applicant accordingly, giving detailed reasons for its refusal. 

7. The notified body shall keep itself apprised of any changes in the generally acknowledged 

state of the art which indicate that the approved type may no longer comply with the applicable 

requirements of this Directive, and shall determine whether such changes require further 

investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating 

to the EU-type examination certificate of all modifications to the approved type that may affect 

the conformity of the radio equipment with the essential requirements of this Directive or the 

conditions for validity of that certificate. 

Such modifications shall require additional approval in the form of an addition to the original EUtype examination certificate. 

8. Each notified body shall inform its notifying authority concerning the EU-type examination 

certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically 

or upon request, make available to its notifying authority the list of such certificates and/or any 

additions thereto refused, suspended or otherwise restricted. 

Each notified body shall inform the other notified bodies concerning the EU-type examination 

certificates and/or any additions thereto which it has refused, withdrawn, suspended or 

otherwise restricted, and, upon request, concerning such certificates and/or additions thereto 

which it has issued. 

Each notified body shall inform the Member States of EU-type examination certificates it has 

issued and/or additions thereto in those cases where harmonized standards the references of 

which have been published in the Official Journal of the European Union have not been applied 

or not been fully applied. 

The Member States, the Commission and the other notified bodies may, on request, obtain a 

copy of the EU-type examination certificates and/or additions thereto. 

On request, the Member States and the Commission may obtain a copy of the technical 

documentation and the results of the examinations carried out by the notified body. 
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The notified body shall keep a copy of the EU-type examination certificate, its annexes and 

additions, as well as the technical file including the documentation submitted by the 

manufacturer for 10 years after the radio equipment has been assessed or until the expiry of the 

validity of that certificate.

9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and 

additions 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. 

10. The manufacturer's authorized representative may lodge the application referred to in point 

3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the 

mandate. 

RED ANNEX V 

Content of Technical Documentation 

The technical documentation shall, wherever applicable, contain at least the following elements: 

(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 compliance with 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 harmonized standards applied in full or in part the references of which have been 

published in the Official Journal of the European Union, and, where those harmonized standards 

have not been applied, descriptions of the solutions adopted to meet the essential requirements 

set out in Article 3, including a list of other relevant technical specifications applied. In the event 

of partly applied harmonized standards, the technical documentation shall specify the parts 

which have been applied; 

(e) copy of the EU declaration of conformity; 

(f) where the conformity assessment module in Annex III has been applied, copy of the EU-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 of Article 10(2) and of the inclusion or not of 

information on the packaging in accordance with Article 10(10).
Version 6.0 (01/30/2023) RED Page 24 of 38

RED ANNEX VI 

EU DECLARATION OF CONFORMITY (No XXX) 

NIST Requirement: The CAB shall demonstrate knowledge of the required content of the 

EU Declaration of Conformity (DoC) as follows:

1. Radio equipment (product, type, batch or serial number): 

2. Name and address of the manufacturer or his authorized representative: 

3. This declaration of conformity is issued under the sole responsibility of the manufacturer. 

4. Object of the declaration (identification of the radio equipment allowing traceability; it may 

include a color image of sufficient clarity where necessary for the identification of the radio 

equipment): 

5. The object of the declaration described above is in conformity with the relevant Union 

harmonization legislation: Directive 2014/53/EU Other Union harmonization legislation where 

applicable

6. References to the relevant harmonized standards used or references to the other technical 

specifications in relation to which conformity is declared. References must be listed with their 

identification number and version and, where applicable, date of issue: 

7. Where applicable, the notified body ... (name, number) ... performed ... (description of 

intervention) ... and issued the EU-type examination certificate: ... 

8. Where applicable, description of accessories and components, including software, which allow 

the radio equipment to operate as intended and covered by the EU declaration of conformity: 

9. Additional information: Signed for and on behalf of: ... 

(place and date of issue): (name, function) (signature):

RED ANNEX VII 

SIMPLIFIED EU DECLARATION OF CONFORMITY 

NIST Requirement: The CAB shall demonstrate knowledge of the required content of the 

simplified EU Declaration of Conformity (DoC) as follows:

The simplified EU declaration of conformity referred to in Article 10(9) shall be provided as 

follows: 

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 declaration of conformity is available at the following internet address:
Version 6.0 (01/30/2023) RED Page 25 of 38

Section 7: Technical Competency Requirements

The CAB personnel shall demonstrate technical competency during the on-site assessment 

conducted by the accreditation body. The areas of knowledge covered during the on-site 

assessment are described in more detail in the RED Assessment Guide prepared by the Radio 

Equipment Compliance Association and UKAS. The information in the RED Assessment Guide

forms the basis for the technical competency assessment. The areas of knowledge assessed will 

include (but are not limited to) the topics listed in the table below: 

Area of Knowledge 

A correct understanding of the Radio Equipment Directive 

A correct understanding of the Scope of the Radio Equipment Directive

A correct understanding of the role of the Notified Body

A working knowledge of the ETSI18 standards system 

A working knowledge of the ECO frequency allocation system (EFIS19) in the EU 

An understanding of the Essential Requirements in Article 3 of the Directive 

A working knowledge of RF exposure requirements 

A working knowledge of Low Voltage requirements 

A working knowledge of Electromagnetic Compatibility requirements 

Correct understanding of the harmonized standards listed in the Official Journal of the 

European Union (OJEU20) 

Understanding of the meaning of and use of the Date of cessation of presumption of 

conformity

Understanding of what the manufacturer obligations are under the Radio Equipment 

Directive – Article 10 – all.

Understanding of what an EU Declaration of Conformity must include (including simplified 

version) 

Knowledge of how to conduct a review of the technical construction file information

Knowledge of what information is to be included in the NB report that supports the EU Type 

Examination Certificate

Knowledge of how to prepare an EU Type Examination Certificate (contents)

Familiarity with the Technical Guidance Notes and REFDOCs published by the Radio 

Equipment Directive Compliance Association

Other related technical issues may be assessed as deemed appropriate by the assessor(s).

18 ETSI - http://www.etsi.org/standards

19 http://www.efis.dk/

20 http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/red_en (Link to the RED 

HS list.) 
Version 6.0 (01/30/2023) RED Page 26 of 38

Section 8: Notifying Authority Obligations

NIST, as the notifying authority of U.S. CABs, must meet the requirements set out in Articles 23, 

24, and 25 of the Radio Equipment Directive. 

The relevant articles of the Radio Equipment Directive that are specific to the notifying authority 

have been reproduced in this Section. In some cases, NIST has provided additional information. 

RED ARTICLE 23 

Notifying authorities 

1. Member States shall designate a notifying authority that shall be responsible for setting up 

and carrying out the necessary procedures for the assessment and notification of conformity 

assessment bodies and the monitoring of notified bodies, including compliance with Article 28. 

NIST: NIST fulfills the role as the notifying authority under the terms of the relevant 

mutual recognition agreements. Refer to Section 1, Introduction.

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 

shall be carried out by a national accreditation body within the meaning of and in accordance 

with Regulation (EC) No 765/2008. 

NIST: The assessment of the CABs seeking Notified Body status shall be carried out by 

U.S. accreditation bodies that have been deemed competent to assess the notified 

bodies. The monitoring of notified bodies is carried out by both the accreditation bodies 

and NIST. 

3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or 

monitoring referred to in paragraph 1 to a body which is not a governmental entity; that body 

shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in 

Article 24. In addition, it shall have arrangements to cover liabilities arising out of its activities. 

NIST: Refer to Section 10 (c). 

4. The notifying authority shall take full responsibility for the tasks performed by the body 

referred to in paragraph 3.
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RED ARTICLE 24 

Requirements relating to notifying authorities 

1. A notifying authority shall be established in such a way that no conflict of interest with 

conformity assessment bodies occurs. 

2. A notifying authority shall be organized and operated so as to safeguard the objectivity and 

impartiality of its activities. 

3. A notifying authority shall be organized in such a way that each decision relating to 

notification of a conformity assessment body is taken by competent persons different from 

those who carried out the assessment. 

NIST: The assessment shall be carried out by the accreditation bodies and the 

notification shall be carried out by NIST. 

4. A notifying authority shall not offer or provide any activities that conformity assessment 

bodies perform or consultancy services on a commercial or competitive basis. 

5. A notifying authority shall safeguard the confidentiality of the information it obtains. 

6. A notifying authority shall have a sufficient number of competent personnel at its disposal for 

the proper performance of its tasks. 

RED ARTICLE 25 

Information obligation on notifying authorities 

Member States shall inform the Commission of their procedures for the assessment and 

notification of conformity assessment bodies and the monitoring of notified bodies, and of any 

changes thereto. 

The Commission shall make that information publicly available.

NIST: This NIST document reflects the NIST procedures for the assessment, notification, 

and monitoring of Notified Bodies. This document is available to the public. 

 

 

 

 

 
Version 6.0 (01/30/2023) RED Page 28 of 38

RED ARTICLE 32 

Changes to notifications 

1. Where a notifying authority has ascertained or has been informed that a notified body no 

longer meets the requirements laid down in Article 26, or that it is failing to fulfil its obligations, 

the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending 

on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall 

immediately inform the Commission and the other Member States accordingly. 

2. In the event of restriction, suspension or withdrawal of notification, or where the notified 

body has ceased its activity, the notifying Member State shall take appropriate steps to ensure 

that the files of that body are either processed by another notified body or kept available for the 

responsible notifying and market surveillance authorities at their request.

 
Version 6.0 (01/30/2023) RED Page 29 of 38

Section 9: Maintaining Notified Body Status

Notified Bodies are subjected to on-going monitoring and surveillance by the responsible 

accreditation body and NIST to ensure continued compliance with these requirements. 

To maintain Notified Body status, the Notified Body shall:

- Maintain accreditation for Notified Body activities

- Comply with reporting requirements to the notifying authority (NIST) and all other parties 

as specified in the directive

- Cooperate with other Notified Bodies in accordance with the directive requirements

- Notify NIST of any contact from the market surveillance authorities in the Member States

within 30 days

- Cooperate with market surveillance authorities in the Member States 

- Maintain membership in and stay up-to-date with the Radio Equipment Directive 

Compliance Association

- Stay up-to-date with standardization activities and monitor the state of the art 

- Maintain technical competence of staff for Notified Body activities

- Renew the Notified Body status as required

Notified Bodies in the United States shall renew their Notified Body status through re-application 

to NIST. This includes submittal of the renewed Scope and Certificate of Accreditation. 

The renewal process will be initiated by NIST in advance of the notification expiration identified 

in New Approach Notified and Designated Organizations (NANDO) database.

NIST will provide the Notified Body with instructions for the renewal. 

This information requested by NIST in support of re-notification will not exceed the 

requirements noted in this document unless additional issues have been brought to NIST’s 

attention. These additional issues will also need to be addressed by the Notified Body. 
Version 6.0 (01/30/2023) RED Page 30 of 38

Section 10: Accreditation Body Requirements

List of Accreditation Bodies 

NIST maintains a list of U.S. accreditation bodies (ABs) that have been evaluated to ensure that 

the assessment and accreditation process meets requirements to support the accreditation of 

Notified Bodies for the purposes of notification. 

Accreditation Body Qualifications

To be eligible for inclusion on the NIST list of accreditation bodies (AB) acceptable for Notified 

Body accreditation for the purposes of notification, the following qualifications shall be

demonstrated and met: 

(a) The AB shall be NIST NVCASE recognized or NIST Listed.

These ABs are located in the United States, are signatories in good standing to an

accreditation body peer organization mutual recognition arrangement and have met the 

requirements specified in the referenced NIST programs. 

(b) The AB shall ensure that the assessment of the Notified Bodies is conducted in 

accordance with the requirements of the Radio Equipment Directive, EA 2/17 M (2020)

and this document.

(c) Per Article 23 (3) of the Radio Equipment Directive, the AB shall have arrangements to 

cover liabilities arising out of its activities. 

(d) The AB assessors shall be technical competent to assess Notified Bodies and shall 

participate in available training on conducting Notified Body assessments.

The AB assessors shall be knowledgeable about the RED Assessment Guide 

interpretations and consider these interpretations during the on-site assessment as part 

of the technical requirements competency assessment (Refer to Section 7, Technical 

Competency Requirements).

The AB assessors shall be knowledgeable about the requirements contained in the NIST 

NB Assessment Checklist for RED Article 3.3g (mobile phones) and the assessor technical 

guidance provided for this essential requirement and shall maintain their understanding 

of the latest technical and administrative requirements related to this essential 

requirement. 

The AB assessors shall be knowledgeable about the requirements contained in the NIST 

NB Assessment Checklist for RED Article 3.4 (common charger) and shall maintain their 
Version 6.0 (01/30/2023) RED Page 31 of 38

understanding of the latest technical and administrative requirements related to this 

essential requirements.

(e) The AB shall ensure that the AB assessors are aware of and informed of the decisions and 

documents issued by the REDCA and distribute related information to assessors. 

[Reference EA 2/17 M:2020 – Section 3.5]

[To facilitate this process, NIST provides the information to the NIST Listed NB ABs. The 

ABs shall distribute the information to the NB assessors.]

Submittal of Documents to NIST 

The AB shall submit relevant documents to NIST (mra@nist.gov) as evidence that the 

qualifications above are met. 

The AB shall identify the names, qualifications, and training records of the assessors that will be 

used to conduct the assessments of Notified Bodies.

The AB shall address and resolve any issues raised by NIST regarding the AB’s qualifications prior 

to being included on the NIST list.

The AB shall provide updated documents and assessor information to NIST upon request.
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Section 11: Document Control

The revision history of this document is maintained below.

Version Date Issued Status Details

V1.0 11/15/2015 FINAL Initial Release

V2.0 07/03/2018 REVISION Updated references to the latest 

versions of the Blue Guide, RED 

Guide, EA-2/17 M and inserted new 

hyperlinks

Clarified that the EC decision process 

for all new NBs is 60 days

Added several clarifications to the 

application checklist

Made minor modifications to the 

wording of several sections

V3.0 09/18/2019 REVISION Updated references to the latest 

versions of the RED Guide and the 

EMCD Guide: 

December 2018

V4.0 05/12/2021 REVISIONS Updated reference: EA 2/17 M:2020

Added sunset date for acceptance of 

ISO/IEC 17020 accreditation (April 

17, 2023)

Removed the option of seeking 

notification under RED 30.4.

Clarified sequential notifications for 

prospective new NBs if applying for 
Version 6.0 (01/30/2023) RED Page 33 of 38

notification for more than one 

Directive

Specified that NBs must provide 

objective evidence of continued 

liability insurance.

Added requirement that AB 

assessors must be aware of REDCA 

documents and decisions per Section 

3.5 of EA 2/17 M:2020.

V5.0 12/14/2022 REVISIONS Updated reference: Blue Guide 2022

Page 8 - Added new requirement 

that the Scope of Accreditation must 

include the essential requirements 

for which the NB has been found 

competent. 

Page 9: Clarified that the Scope of 

Accreditation can include a general 

statement that the NB covers all 

equipment in the RED in lieu of 

including a list of 

products/categories.

 

V6.0 01/30/2023 REVISIONS Page 3 – Clarify conditions when NB 

use is voluntary, including for the 

new RED Article 3.4 (common 

charger)

Section 2 – Added reference and a 

link to Directive (EU) 2022/2380

Section 4 – Added references to the 

new NIST NB Checklists for RED 

Article 3.3g (mobile phones/Galileo) 

and Article 3.4 (common charger)

Section 4 – Added reference to the 

new NIST EU UK Scope of 
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Accreditation document (mandatory 

and optional content)

Section 5 – added references to the 

new NB Checklists for RED Article 

3.3g (mobile phones/Galileo) and 

RED Article 3.4 (common charger)

Section 6 – presented the modified 

RED text (as a result of Directive (EU) 

2022/2380), including the modified 

/new Article 3.3(a), 3.4, and 3a, 10.8 

and the new Annex Ia.

Section 10 (d) – added AB assessor 

requirements for competency for 

RED Articles 3.3g (mobile 

phones/Galileo) and 3.4 (common 

charger)

Appendix I – Application: added all 

RED activated essential requirements 

to the application; added instructions 

for scope expansions (for existing 

NBs); added reference to the new 

NIST Scope document (footnote 23).
Version 6.0 (01/30/2023) RED Page 35 of 38

Appendix I: NB Application Form - RED

Instructions for New NB applicants: Please complete the NB Application Form Parts I, II (all items) and III 

and submit the completed Form along with all supporting documents to NIST via mra@nist.gov

Instructions for RED NBs requesting a Scope Expansion: Please complete the NB Application Form Parts I, 

II (Items 2 and 4 only), and Part III and submit the completed Form along with the two supporting 

documents to NIST via mra@nist.gov.

Part I: General Information 

Name of CAB

Status of CAB 

____ New Applicant; or

 

____ Existing RED NB Seeking a Scope Expansion

Address of main location applying for 

Notification

Select Applicable Essential Requirements (RED Articles) for this application: 

__3.1(a) __3.1(b) __3.2 __3.3g (legacy RTTE&D) __3.3g (mobile phones) __3.4 (common charger)

Primary Contact21 Name

Primary Contact E-mail

Primary Contact Phone Number

Alternate Contact22 Name

Alternate Contact E-mail

Name of Person Completing the Application 

Form 

Signature of Person Completing the 

Application Form and Date

Other comments: 

21 Primary Contact: This person must sign the separate NIST CAB Declaration Form noted in Part II (1) below

22 Alternate Contact: This person must sign the separate the NIST CAB Declaration Form noted in Part II (1) below.
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Part II: Supporting Documents

Please submit the following documents electronically. 

Document/Element CAB Document Name

Include section/page references

New Applicants: All Items

Scope Expansions: 2 and 4 only 

 

1 NIST CAB Declaration Form signed by the Primary and 

Alternate Contacts.

2 Section 4

Scope and Certificate of Accreditation23

3 RED Article 26.4

Organizational chart that includes all other related 

bodies/legal entities, along with a description of all types 

of activities undertaken by the CAB and each other 

related body (such as a testing laboratory or other legal 

entity) and a written explanation of how the CAB 

complies with all three paragraphs of 26.4

4 RED Article 26.6 & RED Annex III – Module B 

Procedures to distinguish the CAB’s NB tasks from all 

other types of activities. The procedures shall address

the full process followed by the CAB for Module B (EUType Examination) for the relevant essential 

requirements for which the CAB is seeking RED NB 

status. 

Note: The procedure must, at a minimum, describe the 

process of accepting an application, conducting a review 

of the technical documentation, preparing the evaluation

report and issuing EU Type Examination Certificate in 

accordance with the requirements of the RED. The text 

should be tailored to the NB process and should not be 

generically copied from the RED. 

5 RED Article 26.6 (a) and 26.7 

List of all personnel performing NB conformity 

assessment tasks, a description of their NB experience, 

23 Please refer to the NIST document titled: NIST Scopes of the EU and UK Regulatory Schemes Covered under the 

TEL MRAs - The CAB’s ISO/IEC 17065 Scope of Accreditation – Mandatory and Optional Content. 
Version 6.0 (01/30/2023) RED Page 37 of 38

and a description or records of each person’s training for 

RED NB competency (include dates of training)

Note: Please address specifically Articles 26.6 (a) and 

26.7 for all essential requirements contained in Article 3.

6 RED Article 26.7 and 26.11

Procedure describing how the CAB will maintain NB 

personnel competence for the elements noted in Article 

26.7 and maintains knowledge of the activities noted in 

26.11.

7 RED Article 26.9 

Valid copy of the current insurance policy as evidence 

that the CAB has obtained Professional Liability 

Insurance or Errors and Omissions Insurance. 

Note: NIST maintains a database of CAB (NB) insurance 

policy validity dates and requires submittal of an 

updated, valid copy of the insurance policy when the 

previous policy has expired.

8 RED Article 36 

Procedure addressing Article 36 information obligations 

(1 to 3) and Annex III information obligations (See also 

Annex III, Module B, 8) 

9 RED Annex III – Module B - 5

Example evaluation report 

10 RED Annex III – Module B - 6

Example EU Type Examination Certificate 

11 Example of contract signed by the CAB’s client(s) for NB 

services. 

Note: Please disclose to clients (and include in the 

contract) all elements requiring release of relevant 

information to NIST, other NBs, Member States, and 

Market Surveillance Authorities as specified in the 

directive and all information requirements that the NB is 

imposing on the manufacturer (reporting of 

modifications, for example)

In accordance with Article 24.5 of the Radio Equipment Directive, NIST will maintain the 

confidentiality of all information received. 
Version 6.0 (01/30/2023) RED Page 38 of 38

Part III: Attestation and Signature of Primary Contact

The CAB’s Primary Contact is responsible for ensuring that the CAB complies at all times with the 

conditions and requirements to apply for and maintain NB status.

I agree with the conditions and requirements specified in Radio Equipment Directive, the NIST CAB 

Declaration and the NIST document titled Requirements and Application for U.S. Conformity 

Assessment Bodies Seeking EU Radio Equipment Directive 2014/53/EU Notified Body Status.

If NIST requires access to additional accreditation documents or information (such as the 

Assessment Report, Deficiency Report, corrective action responses, and assessment checklists 

utilized), my organization will authorize the release of such information. 

I agree that all the statements made in the supporting documents submitted with this NB 

Application Form are correct to the best of my knowledge and are made in good faith.

Date 

Name of CAB 

Signature of Primary Contact 

Printed name of Primary Contact