NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 1 of 33

NIST Notified Body (NB) Assessment Checklist – EMC Directive (EMCD)

November 15, 2015 (Version 1.0)

Checklist to Assess U.S Conformity Assessment Bodies (CABs) for Compliance 

to the EU Electromagnetic Compatibility (EMC) Directive 2014/30/EU Notified Body Requirements

Annex III (Part A - Module B) – EU Type Examination

1. For the complete list of requirements that must be met in order to be designation (notified) to the EU by NIST, please refer to the 

following document: NIST Requirements and Application Instructions for U.S. Conformity Assessment Bodies – Notified Body 

Status for the EU EMC Directive (Version 1.0).

2. The first column of this checklist identifies the EMC Directive requirements (specific to NBs) and additional NIST requirements

(where needed). The first column also identifies the reference to the relevant clause of the EA 2/17 INF: 2014 cross reference 

table of the requirements on Decision (EC) 768/2008 and the applicable conformity assessment standards. 

3. The second column of this checklist provides a place for the CAB to identify the relevant document reference within its quality 

system (policies, procedures, or other documents as required) that demonstrates compliance. 

4. The 3rd, 4th, 5th columns of this checklist are used to indicate whether the CAB meets the particular clause (YES, N/A, NO). 

5. The 6th column of this checklist should be used by the Accreditation Body (AB) assessor(s) to record comments. 

6. If the CAB is being assessed to both the Radio Equipment Directive and EMC Directive, the assessor must first complete the 

NIST NB Assessment Checklist for the Radio Equipment Directive in full and then complete, at a minimum, the relevant 

requirements on this checklist identified with an “*” in the first column. 
NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 2 of 33

Abbreviations: 

ADCO The Administrative Co-operation Working Group

CENELEC European Committee for Electrotechnical Standardization

CEPT European Committee for Post and Telecommunications

EMCD Electromagnetic Compatibility Directive 2014/30/EU

EMC WP EMC Working Party

ETSI European Telecommunications Standards Institute

LVD Low Voltage Directive 2014/35/EU

OJEU Official Journal of the European Union

REFDOCS Reference Documents issued by the EUANB

SRDOCS ETSI System Reference Documents 

TCAM Telecommunications Conformity Assessment and Market Surveillance Committee

TGNs Technical Guidance Notes
NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 3 of 33

Table of Contents

NB ASSESSMENT CHECKLIST – CAB INFORMATION .............................................................................................................................................................5

GENERAL REQUIREMENTS...........................................................................................................................................................................................................6

5.1 LEGAL & CONTRACTUAL........................................................................................................................................................................................................6

5.2 IMPARTIALITY ...........................................................................................................................................................................................................................6

5.3 LIABILITY & FINANCING.........................................................................................................................................................................................................9

STRUCTURAL REQUIREMENTS .................................................................................................................................................................................................10

6.1 ROLE AS NOTIFIED BODY .....................................................................................................................................................................................................10

6.2 COOPERATION ....................................................................................................................................................................................................................11

RESOURCES ....................................................................................................................................................................................................................................13

7.1 PERSONNEL ..............................................................................................................................................................................................................................13

7.2 EQUIPMENT ..............................................................................................................................................................................................................................16

7.3 OUTSOURCING.........................................................................................................................................................................................................................17

INFORMATION REQUIREMENTS & CONFIDENTIALITY.......................................................................................................................................................18

8.1 INFORMATION REQUIREMENTS..........................................................................................................................................................................................18

8.2 CONFIDENTIALITY..................................................................................................................................................................................................................19
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PROCESS REQUIRMENTS.............................................................................................................................................................................................................20

9.1 GENERAL...................................................................................................................................................................................................................................20

9.2 SCOPE OF ACTIVITIES............................................................................................................................................................................................................21

9.3 OPERATIONAL OBLIGATIONS..............................................................................................................................................................................................21

9.4 CONFORMITY ASSESSMENT CRITERIA.............................................................................................................................................................................23

9.5 PREPARATION FOR ASSESSMENT AND CONTRACT REVIEW......................................................................................................................................23

9.6 ASSESSMENT OF APPARATUS CONFORMITY.............................................................................................................................................................24

*ANNEX III: PART A: MODULE B ...............................................................................................................................................................................................24

ANNEX IV: EU DECLARATION OF CONFORMITY..................................................................................................................................................................31
NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 5 of 33

NB ASSESSMENT CHECKLIST – CAB INFORMATION

CAB Name

CAB Location 

Identify Applicable Directives

Select one of the options and complete the 

appropriate checklist(s) as noted in the 

instructions. 

____ EMC Directive Only 

Instructions: Complete this checklist in full. 

 

____ Radio Equipment Directive and EMC Directive 

Instructions:

- Complete the NIST NB Assessment Checklist for the Radio Equipment Directive in full; and 

- Complete, at a minimum, the selected portions of this checklist marked with an * in the first 

column.

Date(s) of the Assessment 

Assessment Type (New or Renewal) 

Assessment Location (On-Site or Remote)

Name of Assessor (s) 

Assessor Signature(s)
NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 6 of 33

NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

GENERAL REQUIREMENTS

5.1 LEGAL & CONTRACTUAL

EMCD Art. 24.2

A conformity assessment body (CAB) 

shall be established under the national 

law of 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. 

(EA 2/17, 5.1.1)

5.2 IMPARTIALITY

EMCD Art. 24.3 (1st Para)

A CAB shall be a third-party body 

independent of the organisation or the 

apparatus it assesses. 

(EA2/17 5.2.1)
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

EMCD Art. 24.4 (1st Para)

A CAB, 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 operation of the 

conformity assessment body or the use of 

such apparatus for personal purposes. 

(EA 2/17 5.2.2)

EMCD Art. 24.4 (2nd Para)

A CAB, 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. 
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

This shall in particular apply to 

consultancy services. 

(EA 2/17 5.2.2)

EMCD Art. 24.4 (3rd Para)

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. 

(EA 2/17 5.2.4)

EMCD Art. 24.5 *

CABs 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. 

(EA2/17 5.2.5)
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

EMCD Art. 24.8

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. 

(EA2/17 5.2.5)

5.3 LIABILITY & FINANCING

EMCD Art. 24.9

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. 
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

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. A body shall be able to 

demonstrate evidence that it has such 

insurance and the coverage limits.

(EA2/17 5.2.5)

STRUCTURAL REQUIREMENTS

6.1 ROLE AS NOTIFIED BODY

EMCD Art. 24.6 (1st para + b)

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. The CAB shall have at its 

disposal the necessary:
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

(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. 

(EA 2/17 6.1.1)

6.2 COOPERATION

*EMCD Article 24.11 *

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 harmonisation 

legislation and shall apply as general 

guidance the administrative decisions 

and documents produced as a result of 

the work of that group.
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

NIST Requirement: The CAB (or one of 

its related bodies located in the United 

States) shall maintain membership in the 

EUANB.

(EA 2/17 6.2.1)

EMCD Art. 36

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 the additional 

NIST Requirement under Article 24.11 –

membership in the EUANB is required by 

NIST. 
NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 13 of 33

NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

RESOURCES

7.1 PERSONNEL

The depth of knowledge of the CAB’s technical personnel shall be assessed based on the technical elements listed in the NIST Requirements and 

Application for U.S. CABs Seeking EMC Directive 2014/30/EU Notified Body Status (Version 1.0).

*EMCD Art. 24.6 (1st para + a) *

A conformity assessment body shall be 

capable of carrying out all the conformity 

assessment tasks assigned to it by 

Annexes 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. The CAB shall have at its 

disposal the necessary:

(a) Personnel with technical knowledge 

and sufficient and appropriate experience 

to perform the conformity assessment 

tasks. 

(EA 2/17 7.1.1)

*
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

*EMCD Art. 24.7 (a-d) *

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 harmonised standards and of 

the relevant provisions of Union 

harmonisation legislation and of national 

legislation; 

[NIST Comment: Annex I is included 

below.]

(d) the ability to draw up certificates, 

records and reports demonstrating that 

assessments have been carried out. 

(EA 2/17 7.1.2)
NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 15 of 33

NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

EMCD Annex I

NIST Requirement: The CAB shall 

demonstrate appropriate knowledge of 

the essential requirements in Annex I

(see below):

*EMCD 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. 

*EMCD Annex I *
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

2. Specific requirements for fixed 

installations - 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 (of Annex 

I). 

7.2 EQUIPMENT

EMCD Art. 24.6 (1st para + last para)

A conformity assessment body shall be 

capable of carrying out all the conformity 

assessment tasks assigned to it by 

Annexes 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.

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 
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

manner and shall have access to all 

necessary equipment or facilities. 

(EA 2/17 7.2.1)

7.3 OUTSOURCING

EMCD Art. 26.1

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. 

(EA 2/17 7.3.1)

EMCD Art. 26.2

Notified bodies shall take full 

responsibility for the tasks performed by 

subcontractors or subsidiaries wherever 

these are established. 

(EA 2/17 7.3.2)

EMCD Art. 26.3
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

Activities may be subcontracted or 

carried out by a subsidiary only with the 

agreement of the client. 

(EA 2/17 7.3.3)

EMCD Art. 26.4

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. 

(EA 2/17 7.3.4)

INFORMATION REQUIREMENTS & CONFIDENTIALITY

8.1 INFORMATION REQUIREMENTS

EMCD Art. 34.1

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;
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

(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. 

(EA 2/17 8.1.1)

EMCD Art. 34.2

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. 

(EA 2/17 8.1.2)

8.2 CONFIDENTIALITY

EMCD Art. 24.10
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

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 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.

(EA 2/17 8.2.1)

PROCESS REQUIRMENTS

9.1 GENERAL

EMCD Art. 24.6 (1st para + para c)

A conformity assessment body shall be 

capable of carrying out all the conformity 

assessment tasks assigned to it by 

Annexes 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. 
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

(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. 

(EA 2/17 9.1.2)

9.2 SCOPE OF ACTIVITIES – Intentionally left blank in EA 2/17

9.3 OPERATIONAL OBLIGATIONS

EMCD Art. 32.1 *

Notified bodies shall carry out 

conformity assessments in accordance 

with the conformity assessment 

procedures provided for in Annex III.

(EA 2/17 9.3.1)

EMCD Art. 32.2 

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 
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A

N Assessor Notes

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 rigour and the level 

of protection required for the compliance 

of the apparatus with this Directive. 

(EA 2/17 9.3.2)

EMCD Art. 32.3

Where a notified body finds that the 

essential requirements set out in Annex I

or corresponding harmonised 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. 

(EA 2/17 9.3.3)

EMCD Art. 32.4

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 
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

suspend or withdraw the certificate if 

necessary. 

(EA 2/17 9.3.4)

EMCD Art. 32.5

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. 

(EA 2/17 9.3.5)

9.4 CONFORMITY ASSESSMENT CRITERIA Intentionally left blank in EA 2/17 

9.5 PREPARATION FOR ASSESSMENT AND CONTRACT REVIEW Intentionally left blank in EA 2/17
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Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

9.6 ASSESSMENT OF APPARATUS CONFORMITY

*ANNEX III: PART A: MODULE B

EU Type Examination 

B.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.

B.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 and supporting evidence 

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 authorized 

representative. 

Annex III Module 
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A

N Assessor Notes

B.3 The manufacturer shall lodge an 

application for EU-type examination with 

a single notified body of its choice. The 

application 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; 

(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.;
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Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

(iii) description and explanations 

necessary for the understanding of those 

drawings and schemes and the operation 

of the apparatus;

(iv) a list of harmonized standards 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, description 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 

which parts have been applied;

(v) results of design calculations made, 

examination carried out, etc.;

(vi) test reports. 

Annex III Module B*

B.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. 
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A

N Assessor Notes

Annex III Module B

B.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. 

Annex III Module B.6

B.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.
NIST NB Assessment Checklist – EMCD (11/15/2015 – Version 1.0) Page 28 of 33

NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

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. 

Annex III Module B *

B.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.
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NB Assessment Checklist – EMC Directive

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

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. 

Annex III Module B *

B.8.Each notified body shall inform its 

notifying authority concerning the EUtype 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. 
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A

N Assessor Notes

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. 

Annex III Module B
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B.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. 

Annex III Module B

B.10. The manufacturer's authorised 

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. 

ANNEX IV: EU DECLARATION OF 

CONFORMITY 

* 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:
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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): 
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(name, function) (signature):

Important Notes: 

- There is no option for a Simplified EU Declaration of Conformity for the EMC Directive. This option is only available for the RED.