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

NIST Notified Body (NB) Assessment Checklist – Radio Equipment Directive (RED)

November 15, 2015 (Version 1.0)

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

to the EU Radio Equipment Directive (RED) 2014/53/EU Notified Body Requirements 

Annex III (Module B) – EU Type Examination

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

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

EU Radio Equipment Directive (Version 1.0)

2. This NIST NB Assessment Checklist for the Radio Equipment Directive should be utilized in conjunction with the Assessment 

Guide1

, which contains technical competency guidance. 

3. The first column of this checklist identifies the Radio Equipment 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 basic conformity assessment standards. 

4. 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. 

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

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

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

checklist in full and the relevant portions of the NIST NB Assessment Checklist for the EMC Directive marked with an “*” in 

the first column. 

 1 RED Notified Body Accreditation/Notification Assessment Guide Document (V1.0c)
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Abbreviations: 

ADCO The Administrative Co-operation Working Group

CENELEC European Committee for Electrotechnical standardization

CEPT European Committee for Post and Telecommunications

ECO European Communications Office 

EFIS ECO Frequency Information System

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 RTTA CA

SRDOCS ETSI System Reference Documents 

TCAM Telecommunications Conformity Assessment and Market Surveillance Committee

TGNs Technical Guidance Notes
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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

5.4 IDENTIFICATION OF NOTIFIED BODY..................................................................................................................................................................................9

STRUCTURAL REQUIRMENTS....................................................................................................................................................................................................10

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

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

RESOURCES ....................................................................................................................................................................................................................................12

7.1 PERSONNEL ..............................................................................................................................................................................................................................12

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.............................................................................................................................................................................................................19

9.1 GENERAL...................................................................................................................................................................................................................................19

9.2 SCOPE OF ACTIVITIES............................................................................................................................................................................................................20

9.3 OPERATIONAL OBLIGATIONS..............................................................................................................................................................................................20

9.4 CONFORMITY ASSESSMENT CRITERIA.............................................................................................................................................................................22

9.5 PREPARATION FOR ASSESSMENT AND CONTRACT REVIEW......................................................................................................................................22

9.6 ASSESSMENT OF RADIO EQUIPMENT CONFORMITY.....................................................................................................................................................23

ANNEX III: MODULE B..................................................................................................................................................................................................................24

ANNEX V: CONTENTS OF TECHNICAL DOCUMENTATION.................................................................................................................................................29

ANNEX VI: EU DECLARATION OF CONFORMITY..................................................................................................................................................................31

ANNEX VII: SIMPLIFIED EU DECLARATION OF CONFORMITY..........................................................................................................................................32
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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. 

____ Radio Equipment Directive Only 

Instructions: Complete this checklist in full. 

 

____ Radio Equipment Directive and EMC Directive 

Instructions:

- Complete this checklist in full; and 

- Complete selected portions of the NIST NB Assessment Checklist for the EMC 

Directive 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 the Assessor(s) 

Assessor Signature (s)
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NB Assessment Checklist – Radio Equipment Directive 

Knowledge Area / Requirement NB Reference Document Y N

A

N Assessor Notes

GENERAL REQUIREMENTS

5.1 LEGAL & CONTRACTUAL

RED Art. 26.2

A conformity assessment body (CAB) 

shall be established under the national 

law of Member State and have legal 

personality in the United States. 

NIST Requirement: 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

RED Art. 26.3 

A CAB shall be a third-party body 

independent of the organisation or the 

radio equipment it assesses. 

(EA2/17 5.2.1)
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RED Art. 26.4 (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 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 

operation of the conformity assessment 

body or the use of such radio equipment 

for personal purposes. (EA 2/17 5.2.2)

RED Art. 26.4 (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 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 judgement or integrity 

in relation to conformity assessment 

activities for which they are notified. 

This shall in particular apply to 

consultancy services. 

(EA 2/17 5.2.2)
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RED Art. 26.4 (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)

RED Art. 26.5

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)

RED Art. 26.8

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 
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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

RED Art. 26.9

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. 

(EA2/17 5.2.5)

Just added – add to requirements 

document also 

5.4 IDENTIFICATION OF NOTIFIED BODY

RED Art. 20.3

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.
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The identification number of the notified 

body shall have the same height as the 

CE marking. 

The identification number of the notified 

body shall be affixed by the notified 

body itself or, under its instructions, by 

the manufacturer or his authorised 

representative. 

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. (EA 2/17 5.4.1)

STRUCTURAL REQUIRMENTS

6.1 ROLE AS NOTIFIED BODY

RED Art. 26.6 (1st para + b)

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. The CAB shall have at its 

disposal the necessary:

(b) descriptions of procedures in 

accordance with which conformity 
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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

RED Article 26.11

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, 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 

harmonisation 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 Directive Compliance 

Association (RED CA). 
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(EA 2/17 6.2.1)

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 Program Requirements 

(Section XXXX) and the Assessment Guide – Section 7.1

RED Art. 26.6 (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 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. 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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RED Art. 26.7 (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 Article 3, of the 

applicable harmonised standards and of 

the relevant provisions of Union 

harmonisation legislation and of national 

legislation; 

[NIST Comment– See Article 3 below.]

(d) the ability to draw up EU-type 

examination certificates or quality 

system approvals, records and reports 

demonstrating that assessments have 

been carried out. 

(EA 2/17 7.1.2)

RED Article3

NIST Requirement: The CAB shall 

demonstrate appropriate knowledge of 
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all essential requirements in Article 3 as 

follows:

RED Art. 3.1

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. 

RED Art. 3.2

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. 

RED Art. 3.3

Radio equipment within certain 

categories or classes shall be so 

constructed that it complies with the 

following essential requirements:
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a) radio equipment interworks with 

accessories, in particular with 

common chargers;

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;

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 
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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. 

7.2 EQUIPMENT

RED Art. 26.6 (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 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.

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. 

(EA 2/17 7.2.1)
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7.3 OUTSOURCING

RED Art. 28.1

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. 

(EA 2/17 7.3.1)

RED Art. 28.2

Notified bodies shall take full 

responsibility for the tasks performed by 

subcontractors or subsidiaries wherever 

these are established. 

(EA 2/17 7.3.2)

RED Art. 28.3

Activities may be subcontracted or 

carried out by a subsidiary only with the 

agreement of the client. 

(EA 2/17 7.3.3)

RED Art. 28.4

Notified bodies shall keep at the disposal 

of the notifying authority the relevant 

documents concerning the assessment of 

the qualifications of the subcontractor or 
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the subsidiary and the work carried out 

by them under Annexes III and IV. 

(EA 2/17 7.3.4)

INFORMATION REQUIREMENTS & CONFIDENTIALITY

8.1 INFORMATION REQUIREMENTS

RED Art. 36.1

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. 

(EA 2/17 8.1.1)

RED Art. 36.2
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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. 

(EA 2/17 8.1.2)

8.2 CONFIDENTIALITY

RED Art. 26.10

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.

(EA 2/17 8.2.1)

PROCESS REQUIRMENTS

9.1 GENERAL
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RED Art. 26.6 (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 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. 

(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. 

(EA 2/17 9.1.2)

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

9.3 OPERATIONAL OBLIGATIONS

RED Art. 34.1

Notified bodies shall carry out 

conformity assessments in accordance 

with the conformity assessment 

procedures provided for in Annexes III 

and IV.

(EA 2/17 9.3.1)

RED Art. 34.2 
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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 rigour and the level 

of protection required for the compliance 

of the radio equipment with this 

Directive. (EA 2/17 9.3.2)

RED Art. 34.3

Where a notified body finds that the 

essential requirements set out in Article 3 

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 an EU-type examination 

certificate or a quality system approval. 

(EA 2/17 9.3.3)

RED Art. 34.4

Where, in the course of the monitoring of 

conformity following the issue of an EU-

type examination certificate or a quality 
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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. 

(EA 2/17 9.3.4)

RED Art. 34.5

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. 

(EA 2/17 9.3.5)

RED Art. 36.3

Notified bodies shall fulfil information 

obligations under Annexes III and IV. 

[NIST Comment: As applicable only –

not all NBs will seek Annex IV 

notification.]

(EA 2/17 9.3.1)

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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9.6 ASSESSMENT OF RADIO EQUIPMENT CONFORMITY

RED Art. 10.2

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. 

NIST Requirement: The CAB shall demonstrate 

their understanding of this requirement.

RED Art. 10.8

Manufacturers shall ensure that the radio 

equipment is accompanied by instructions and 

safety information in a language which can be 

easily understood by consumers and other endusers, as determined by the Member State 

concerned. 

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.

NIST Requirement: The CAB shall demonstrate 

their understanding of this requirement.
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RED Art. 10.10

In cases of restrictions on putting into service or of 

requirements for authorisation 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 authorisation of use exist. Such information 

shall be completed in the instructions 

accompanying the radio equipment. 

NIST Requirement: The CAB shall demonstrate 

their understanding of this requirement.

ANNEX III: MODULE B

Annex III, Module B.1 and B.2

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). 

Annex III Module B.3

The application shall include: 
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(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 

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 

harmonised 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. 

Annex III Module B.4
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The notified body shall examine the technical 

documentation and supporting evidence to assess 

the adequacy of the technical design of the radio 

equipment. 

Annex III Module 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 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. 

Annex III Module B.6

Where the type meets the requirements of this 

Directive that apply to the radio equipment 

concerned, the notified body shall issue an EUtype examination certificate to the manufacturer. 

That certificate shall contain:

1. the name and address of the manufacturer

2. the conclusions of the examination 

3. the aspects of the essential requirements 

covered by the examination 

4. the conditions (if any) for its validity and

5. the necessary data for identification of the 

assessed type. 

The EU-type examination certificate may have one 

or more annexes attached.
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6. 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. 

Annex III Module 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.

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 EU-type 

examination certificate. 

Annex III Module B.8
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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 harmonised 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 EUtype 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. 

Annex III Module B.9

The manufacturer shall keep a copy of the EUtype 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. 

Annex III Module 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 

[above], provided that they are specified in the 

mandate. 

ANNEX V: CONTENTS 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; 
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(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 harmonised 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 harmonised 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 harmonised 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;
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(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). 

ANNEX VI: EU DECLARATION OF 

CONFORMITY 

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 

authorised 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 colour 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 

harmonisation legislation: 

Directive 2014/53/EU

Other Union harmonisation legislation where 

applicable
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6. References to the relevant harmonised 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):

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: 
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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: