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Requirements & Application

for

U.S. Conformity Assessment Bodies

Seeking

 Electromagnetic Compatibility (EMC)

Directive 2014/30/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: EMC DIRECTIVE AND NIST REQUIREMENTS FOR NOTIFIED BODIES 10

SECTION 7: TECHNICAL COMPETENCY REQUIREMENTS 19

SECTION 8: NOTIFYING AUTHORITY OBLIGATIONS 20

SECTION 9: MAINTAINING NOTIFIED BODY STATUS 23

SECTION 10: ACCREDITATION BODY REQUIREMENTS 24

SECTION 11: DOCUMENT CONTROL 26

APPENDIX I: NB APPLICATION FORM – EMC DIRECTIVE 28
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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 EMC Directive 2014/30/EU - Annex III – Part A (Module B: EUType Examination). 

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

the EMC Directive, the applicant CAB shall demonstrate compliance with the requirements 

specified in the EMC Directive and 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. 

For the EMC Directive, the Notified Body examines the technical design of an apparatus and 

verifies and attests that the technical design of the apparatus meets the essential requirements 

set out in Annex I (1) of the EMC Directive as follows:

Equipment shall be so designed and manufactured, having regard to the state of the art, 

as to ensure that:

(a) the electromagnetic disturbance generated does not exceed the level above which 

radio and telecommunications equipment or other equipment cannot operate as 

intended;

(b) it has a level of immunity to the electromagnetic disturbance to be expected in its 

intended use which allows it to operate without unacceptable degradation of its intended 

use.

The Notified Body then writes an evaluation report (that may be released only upon agreement 

with the manufacturer) and issues an EU-Type Examination Certificate. 

The manufacturer maintains the EU-Type Examination in the technical documentation that 

supports its Declaration of Conformity. 

Under the EMC Directive, use of a Notified Body is voluntary. [Article 14 of the EMC Directive 

does not identify any circumstances where an EU-Type Examination Certificate is mandatory.]

In the role as Notified Body, the CAB does not test the apparatus (equipment/device). 

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 for monitoring on-going compliance of these Notified Bodies. 

Exclusions 

The following topics are not addressed in this document:

EMC Directive Module C – EMC Directive Annex III Part B refers to 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. 

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

the European Union’s Radio Equipment Directive (2014/53/EU). The requirements and 

application for RED 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 EMC

Directive 2014/30/EU, the EMC Directive 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 EMC Directive as 

issued by the European Commission, the European Union Association of Notified Bodies (EUANB 

– Group of Notified Bodies for the EMC Directive), 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 (2016) – July 26, 2016

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

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

Electromagnetic Compatibility Directive6 2014/30/EU

Guide for the EMC Directive 2014/30/EU7 (December 2018)

Technical Guidance Notes issued by the EUANB 8(Hosted on the RED CA website)

List of Harmonized Standards applicable for the EMC Directive9 as published in the Official 

Journal of the European Union. View the links at bottom of the webpage under “Publications in 

the Official Journal”. 

Low Voltage Directive10 2014/35/EU

5 https://ec.europa.eu/growth/content/%E2%80%98blue-guide%E2%80%99-implementation-eu-product-rules_en

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

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

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

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

10 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 submit the NB Application Form (refer to Appendix I on page 27) 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 EMC 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 organizations that have 

demonstrated that all requirements have been met. The European Commission conducts a review 

of all notifications. 

A CAB becomes a 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=153681

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

the EMC 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 will maintain 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 1702011 that wish to seek NB status can apply to 

NIST under the process covered in EMCD Article 27.2. 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 European Commission, 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 EMCD).

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

When a CAB is applying as a NB for the first time (and does not yet have a NB number assigned 

by the European Commission), the first notification to the European Commission can only 

include 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 of least 120 days to obtain NB status for both the EMCD and the RED).

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

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

assessment standard used. The technical assessment will include use of the NIST NB 

Assessment Checklist (EMC Directive). 

Scope of Accreditation

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

Scope of Accreditation shall include at least the following information: 

(a) The basic conformity assessment standard [ISO/IEC 17065 or ISO/IEC 17020 (until April 17, 

2023)] which is used as reference and applied in full for the accreditation of the CAB

(b) A reference to EA-2/17 M: 2020 (or most current version) to confirm that the NB complies 

with the additional requirements stated therein, and to confirm that the accreditation may be 

considered suitable for notification purposes

(c) Identification of the directive (EMC Directive 2014/30/EU)

(d) Identification of the conformity assessment procedure used (Module B) 

(e) products/category – family – homogeneous groups of products [refer to Article 24.6]

Examples of categories of apparatus include:

Telecom Terminal Equipment; Power supplies; Micro-controllers; PC cards

Important Notes: 

While fixed installations are covered by the EMDC, evaluation of fixed installations is outside the 

scope of the NB. 

Equipment types regulated by other EU Directives that cover EMC (such as the Radio Equipment 

Directive) do not also fall under the EMC Directive and should not be listed in the 

products/category section of the Scope of Accreditation.
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Section 5: Assessment Tools

NIST NB Assessment Checklist (EMC Directive)

NIST NB Assessment Checklist

NIST has developed a NB Assessment Checklist - EMC Directive that contains (1) the EMC 

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

Notified Bodies. 

Accreditation Bodies shall use the NIST NB Assessment Checklist – EMC Directive to document 

the compliance information obtained during the on-site assessment.
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Section 6: EMC Directive and NIST Requirements for Notified Bodies

The articles and annexes of the EMC Directive that are specific to Notified Bodies have been 

reproduced (presented in order in which these appear in the EMC Directive). 

In some cases, it has been necessary for NIST to specify an additional requirement or to clarify an 

article. (This information is highlighted in green in this Section.)

These requirements are also reproduced in the NIST NB Assessment Checklist – EMC Directive. 

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

EMC Directive - ARTICLE 6 

Essential Requirements 

The equipment shall meet the essential requirements set out in Annex I.

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

requirements in Annex I.

EMC Directive ANNEX I 

1. General requirements

Equipment shall be so designed and manufactured, having regard to the state of the art, as to 

ensure that:

(a) the electromagnetic disturbance generated does not exceed the level above which radio and 

telecommunications equipment or other equipment cannot operate as intended;

(b) it has a level of immunity to the electromagnetic disturbance to be expected in its intended 

use which allows it to operate without unacceptable degradation of its intended use.

2. Specific requirements for fixed installations [NIST Note: Fixed Installations are outside the 

Scope of the NB]

Installation and intended use of components

A fixed installation shall be installed applying good engineering practices and respecting the 

information on the intended use of its components, with a view to meeting the essential 

requirements set out in point 1.

 
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EMC Directive - ARTICLE 24 

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: A 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 apparatus 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 apparatus 

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 apparatus which they assess, nor the 

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

are necessary for the operations of the conformity assessment body or the use of such 

apparatus 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 those 

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

activity that may conflict with their independence of judgement or integrity in relation to 

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

tasks assigned to it by Annex III and 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 

apparatus 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 the 

apparatus 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 and shall have access to all necessary equipment or facilities.

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;

(c) appropriate knowledge and understanding of the essential requirements set out in Annex I, of 

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

legislation and of national legislation;

(d) the ability to draw up certificates, 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.
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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: A Notified Body shall have Civil Liability Insurance (in the United 

States, this is also known as professional liability insurance or errors and omissions 

insurance), in an amount that is sufficient in coverage to protect itself 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 Annex III or any 

provision of national law giving effect to it, 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 standardisation 

activities 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 EUANB. 

EMC Directive - ARTICLE 26 

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 24 and shall inform the notifying authority accordingly.

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 Annex III.
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EMC Directive –ARTICLE 32 

Operational obligations of notified bodies 

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

assessment procedures provided for in Annex III.

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 

apparatus 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 apparatus with this Directive.

3. Where a notified body finds that the essential requirements set out in Annex I 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 a certificate.

4. Where, in the course of the monitoring of conformity following the issue of a certificate, a 

notified body finds that an apparatus no longer complies, it shall require the manufacturer to 

take appropriate corrective measures and shall suspend or withdraw the certificate 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 certificates, as appropriate.

 

EMC Directive - ARTICLE 34 

Information obligation on notified bodies 

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

(a) any refusal, restriction, suspension or withdrawal of a certificate;

(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.
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2. Notified bodies shall provide the other bodies notified under this Directive carrying out similar 

conformity assessment activities covering the same apparatus with relevant information on 

issues relating to negative and, on request, positive conformity assessment results.

EMC Directive - ARTICLE 36 

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 EMC Directive Article 24.11 

– membership in the EUANB is required.

EMC Directive - Annex III – Part A 

Module B: EU-type examination 

ANNEX III

PART A

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 an apparatus and verifies and attests that the technical 

design of the apparatus meets the essential requirements set out in point 1 of Annex I.

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

design of the apparatus through examination of the technical documentation referred to in point 

3, without examination of a specimen (design type). It may be restricted to some aspects of the 

essential requirements as specified by the manufacturer or his authorised representative.

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

body of his choice.

The application shall specify the aspects of the essential requirements for which examination is 

requested and shall include:

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

representative, his name and address as well;
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(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 apparatus 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 apparatus. The technical documentation shall contain, 

wherever applicable, at least the following elements:

(i) a general description of the apparatus;

(ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, 

circuits, etc.;

(iii) descriptions and explanations necessary for the understanding of those drawings and 

schemes and the operation of the apparatus;

(iv) 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 

of this Directive, 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;

(v) results of design calculations made, examinations carried out, etc.;

(vi) test reports.

4. The notified body shall examine the technical documentation to assess the adequacy of the 

technical design of the apparatus in relation to the aspects of the essential requirements for 

which examination is requested.

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 vis-à-vis the 

notifying authorities, 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 apparatus 

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 

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 approved type. 

The EU-type examination certificate may have one or more annexes attached.
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The EU-type examination certificate and its annexes shall contain all relevant information to 

allow the conformity of manufactured apparatus 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 apparatus 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 EU-type 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.

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

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

Commission and the Member States may obtain a copy of the technical documentation and the 

results of the examinations carried out by the notified body. 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, 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 apparatus 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.
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EMC Directive - ANNEX IV 

EU DECLARATION OF CONFORMITY (No Xxxx) 

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

EU Declaration of Conformity (DoC) 

1. Apparatus model/Product (product, type, batch or serial number):

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

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

4. Object of the declaration (identification of apparatus allowing traceability; it may include a 

colour image of sufficient clarity where necessary for the identification of the apparatus):

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

harmonisation legislation:

6. References to the relevant harmonised standards used, including the date of the standard, or 

references to the other technical specifications, including the date of the specification, in 

relation to which conformity is declared:

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

intervention) and issued the certificate:

8. Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):
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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 assessed will include (but are not 

limited to) the topics listed in the table below: 

Area of Knowledge 

A correct understanding of the EMC Directive 

A correct understanding of the Scope of the EMC Directive and exclusions

A correct understanding of the role of the Notified Body

A working knowledge of the CENELEC12 standards system 

An understanding of the Essential Requirements in Annex I of the Directive 

A working knowledge of Electromagnetic Compatibility requirements 

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

European Union (OJEU13) 

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 EMC Directive – Article 

7 – all

Understanding of what an EU Declaration of Conformity must include 

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 EUANB

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

12 CENELEC: http://www.cenelec.eu/

13 https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/electromagneticcompatibility_en 
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Section 8: Notifying Authority Obligations

NIST, as the notifying authority of U.S. CABs, must meet the requirements set out in Articles 21, 

22, 23 and 30 of the EMC Directive. 

The relevant articles of the EMC Directive that are specific to the notifying authority have been 

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

EMCD ARTICLE 21 

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 26. 

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 22. 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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EMCD ARTICLE 22 

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. 

EMCD ARTICLE 23 

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. 

 

 

 

 

 
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EMCD ARTICLE 30 

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 24, 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.

 
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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)

- 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 EUANB.

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

- Maintain technical competence of staff for Notified Body activities

- Maintain required liability insurance per EMCD Article 24.9

- Renew the Notified Body status as required

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

to NIST. 

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

the NB and identified in the New Approach Notified and Designated Organizations (NANDO)

website. 

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. 
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Section 10: Accreditation Body Requirements

List of Accreditation Bodies 

NIST will maintain 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 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 EMC Directive, EA 2/17 and this document.

(c) Per Article 21 (3) of the EMC 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 EMC Directive interpretations issued by 

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

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

Competency Requirements).

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

documents issued by the EUANB 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.]
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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 07/18/2018 REVISION Updated references to the latest 

versions of the Blue Guide, EMCD 

Guide, EA-2/17 M and inserted new 

hyperlinks

Clarified that the EC decision process 

for all new NBs is 60 days

Clarified that fixed installations are 

outside the scope of the NB

Made minor modifications to the 

wording of several sections

Added several clarifications to the 

application checklist

V3.0 09/18/2019 REVISION Updated reference to the most 

recent version of the EMCD Guide 

(December 2018)

V4.0 06/01/2021 REVISION Updated reference: EA 2/17 M:2020

Added sunset date for acceptance of 

ISO/IEC 17020 accreditation (April 

17, 2023)
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Removed the option of seeking 

notification under EMCD 28.4.

Clarified sequential notifications for 

prospective new NBs if applying for 

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 EUANB 

documents and decisions per Section 

3.5 of EA 2/17 M:2020.
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Appendix I: NB Application Form – EMC Directive 

Instructions: Please complete the NB Application Form and submit it along with all supporting 

documents to NIST via mra@nist.gov.

Part I: General Information 

Name of CAB

Address of main location applying for 

Notification

Primary Contact14 Name

Primary Contact E-mail

Primary Contact Phone Number

Alternate Contact15 Name

Alternate Contact E-mail

Name of Person Completing the 

Application Form

Signature of Person Completing the 

Application Form 

Date Completed

Reserved for CAB comments/other information: 

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

15 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 CAB Document Name and page (or 

other) references 

1 NIST CAB Declaration Form signed by the Primary and 

Alternate Contacts

2 Section 4

Scope and Certificate of Accreditation 

3 EMCD Article 24.4

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 24.4

4 EMCD Article 24.6 (b) & EMCD Annex III – Module B 

Procedure to distinguish the CAB’s NB tasks and all 

other types of activities. The procedures shall address 

the full process followed by the CAB for Module B (EUType Examination. 

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 

EMCD. The text should be tailored to the NB process 

and should not be generically copied from the EMCD. 

5 EMCD Article 24.6 (a) and 24.7 

List of all personnel performing NB conformity 

assessment tasks, a description of their experience, and 

a description or records of each person’s training for 

EMCD NB competency (include dates of training).

Note: Please address specifically Articles 24.6 (a) and 

24.7 for the essential requirements contained in Annex I.

6 EMCD Article 24.7 and 24.11

Procedure describing how the CAB will maintain NB 

personnel competence for the elements noted in Article 
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24.7 and maintains knowledge of the activities noted in 

24.11.

7 EMCD Article 24.9 

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 EMCD Article 34 

Procedure addressing Article 34 information obligations 

(1 to 2) and Annex III information obligations (See 

Annex III, Module B, 8) 

9 EMCD Annex III – Module B - 5

Example evaluation report 

10 EMCD 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 22.5 of the EMCD, NIST will maintain the confidentiality of all 

information received.
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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 NIST CAB Declaration and the NIST 

document titled Requirements and Application for U.S. Conformity Assessment Bodies Seeking EU 

EMC Directive 2014/30/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