V1.0c December 2014

RED Notified Body Accreditation/Notification assessment Guide Document

(V1.0c)

Introduction

This is the first issue of the accreditation/notification assessment guide for Notified Bodies under the Radio Equipment Directive (for year 2015).

The Radio Equipment Directive Article 3.1(a) and Article 3.1(b) do not require a manufacturer to involve a Notified Body even where the 

equipment has not followed the harmonised standards. However they (the manufacturer) are completely free to do so. 

A formal question has been asked if a Notified Body can ask for an Article 3.2 assessment only, a formal answer has being received from the 

TCAM Chairman who emphasised that the NB/CAB should meet Article 34.3 of the RED which clearly mentions the Essential requirements of 

Article 3. 

It is further noted that Article 29.2 which clearly indicates:

The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module 

or modules and the radio equipment for which that body claims to be competent, as well as by an accreditation certificate, where one exists, 

issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 26.) 

The view is that Art 26 only allows module choice and equipment choice, not the essential requirement choice.

Therefore the accreditation/notification should demonstrate meeting the requirements of the Annex, which includes the option to assess all 

relevant articles under the Directive. There is a presumption of conformity where a product has followed all relevant harmonised standards as 

listed in the Official Journal of Europe (OJEU) at the time the product is placed on the market.

The manufacturer does not need to ask a NB for an assessment if all relevant HS have been applied for Article 3.2 but MUST require an 

assessment where harmonised standards for Article 3.2 have not been followed in full, in order to receive an EU Type Examination Certificate 

from a NB in order to enter the market.

By being listed in NANDO an NB must accept any request from a manufacturer to assess a product even in cases where the Harmonised 

standards have all been applied by the manufacturer. This requires a certain level of technical knowledge, not just of standards, or those skills 

of an experienced test engineer. The Radio equipment Directive does not detail the expected technical knowledge. This Guide was produced in 

co-operation of UKAS (the UK accreditation Body) and the R&TTE CA committee to suggest a baseline skills level assessment to the EU and 

MRA Accreditation Bodies. This document will be reviewed annually.

The Notified Body has the role of technical evaluation, which can require a skill set with a mix of spectrum knowledge, co-existence studies, 

system reference document (SRDoc) and ESO (ETSI / CENELEC) standards body activity including some means of access to drafting groups. 
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These skills are rarely obtained from just testing products, and this document aims to guide the assessors as to a typical skill set expected for a 

Radio Equipment Directive Notified Body.

The Radio Equipment Directive Notified Body skill set is fairly unique around the world. It is different to some other certification and inspection 

skills, such as the Telecommunication Certification Body (TCB) for FCC, where the FCC makes the technical rules, and the TCB ensure the FCC 

technical rules are followed. The TCB cannot interpret areas where rules (standards) have not been followed; they have to ask the FCC for their 

agreement via the KDB process. A Radio Equipment Directive Notified Body does not have to ask permission from a National Authority before

accepting a deviation; however they take on the liability themselves (one of the reasons for the requirement for professional indemnity and public 

liability insurance). Due to this high level technical decision making, there is a requirement to ensure the general technical competence of the 

Radio Equipment Directive Notified Bodies is at a sufficient level.

This document is a guide; alternative answers and explanations shall be considered by assessors and recorded as acceptable, or not, in the 

assessment report. As normal, further evidence may be requested for any area. It is not required for each member of the NB to meet this 

guidance, but across the NB team (if more than one person), the skills should be met.

Note: for all the “Whereas” statements (recitals) referred to within this document. They (the “Whereas” statements) are typically not directly legal requirements and hence may not be included 

in the National legislation. However it is considered important that the RED NB understand this “Whereas” information.

Checklist

Knowledge Area / Requirement Question(s) Y N

A

N Expected content within answers

GENERAL REQUIREMENTS

5.1 LEGAL & CONTRACTUAL

Article 26.2 

A conformity assessment body shall 

be established under national law of 

a Member State and have legal 

personality.

(768/2008 Article R17.2 & draft 

EA2/17 5.1.1)

How does the NB demonstrate 

legal personality?

An example would be a Companies House 

listing in the UK.

5.2 IMPARTIALITY
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Article 26.3 

A conformity assessment body shall 

be a third-party body independent of 

the organisation or the radio 

equipment it assesses.

(768/2008 Article R17.3 & draft 

EA2/17 5.2.1)

How does the NB demonstrate 

independence?

Does the NB identify risks to its 

impartiality?

[Look for guidance in 17020 / 17065 and 

ILAC P15?]

Article 26.4

A conformity assessment body, its 

top level management and the 

personnel responsible for carrying 

out the conformity assessment tasks 

shall not be the designer, 

manufacturer, supplier, installer, 

purchaser, owner, user or maintainer 

of the radio equipment which they 

assess, nor the representative of any 

of those parties.

(768/2008 Article R17.4 & draft 

EA2/17 5.2.2)

How does the NB demonstrate 

they meet this requirement?

Does their web site etc. suggest 

they offer consultancy?, how do 

they ensure their subsidiaries or 

subcontractors do not offer 

consultancy”?

This precludes involvement in the generation 

of any documentation or any justification for 

the technical construction files.

Article 26.5

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 

What is “requisite technical 

competence”, how is this 

interpreted, justified and 

documented?

What are the knowledge, 

experience and qualification 

requirements expected for a 

member of the NB?

How does the structure and 

policy demonstrate that the staff 

are free from financial 

inducements?

An example could be an electronic / 

telecommunications related engineering 

degree and 3 years relevant experience or 7

years relevant experience.

Knowledge of ETSI Standards process; EFIS; 

SRDocs; sharing studies; co-existence.

Professional membership; FEANI, Eur Ing; 

CEng (UK) Dipl. Ing (Germany), PE and 

equivalents may indicate a high level of 

technical knowledge, provided this is in a 

relevant field.

They should also demonstrate their subject 
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groups of persons with an interest in 

the results of those activities” 

(768/2008 Article R17.5 & draft 

EA2/17 5.2.5)

related Continuing Professional Development 

(CPD) in topics related to the Radio 

equipment Directive, (Membership of the 

R&TTE CA / RED CA counts towards this).

Article 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 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.

(768/2008 Article R17.5 & draft 

EA2/17 5.2.5)

How is this demonstrated?

ISO 17020 / ISO 17065 –

typically via an impartiality 

committee, the NB must not have 

a controlling interest in the voting 

of this committee.

Review of contract of 

employment, including 

subcontractors as applicable?

Do they have a NDA with the 

external impartiality committee 

members, including their 

declaration of competitive 

interests?

Minimum size for an impartiality committee is 

expected to be three (for small NB 

operations) the NB member, a 17020 / 17065 

knowledgeable person, and a customer, all 

with equal voting rights.

They should have a NDA signed with each 

external party, and consider adding a clause 

for the case where the NB disagrees with the 

findings, the NB can ask for a review from the 

Accreditation Body or Member State 

Authority.

5.3 LIABILITY & FINANCING

Article 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.

The NB shall produce a (time) 

valid certificate of liability 

insurance. Record what the value 

of the insurance is, is this 

appropriate for the work of the NB 

if they were to be sued?

NB should be able to provide a justification of 

the level obtained. They should also be able 

to demonstrate the insurer understands the 

NB’s activities. Typically this activity needs

Professional Indemnity and Public Liability, 

appropriate to their and their customer 

location(s). 
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(768/2008 Article R17.9 & draft 

EA2/17 5.2.5)

5.4 IDENTIFICATION OF NOTIFIED BODY

Article 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.

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.

(768/2008 Article R12.3 & draft 

EA2/17 5.4.1)

Ask when NB number is applied 

to label.

What is the size requirement of 

an NB number on a device?

Where is it recorded that this is 

checked against the requirements 

of Annex VII, (including the 

simplified version)?

RED Annex IV is the old R&TTE CA Annex 5, 

Full quality Assurance.

Size of NB number shall be the same size as 

CE mark.

STRUCTURAL REQUIRMENTS

6.1 ROLE AS NOTIFIED BODY

Article 26.6 

A conformity assessment body shall 

be capable of carrying out all the 

conformity assessment tasks 

assigned to it by Annexes III and IV 

in relation to which it has been 

notified, whether those tasks are 

carried out by the conformity 

Review procedures to see if this 

requirement is met.
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assessment body itself or on its 

behalf and under its responsibility:

(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.

(768/2008 Article R17.6(b) & draft 

EA2/17 6.1.1)

6.2 COOPERATION

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 

Relevant standardisation 

activities – ETSI (possibly 

CENELEC as well).

CEPT and ECC (frequency 

planning).

NB Co-ordination group R&TTE 

CA or the successor – must be 

members as many documents 

are restricted to members only, 

members are listed on web site at 

http://www.rtteca.com/html/notifie

d_bodies.htm.
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the work of that group.

(768/2008 Article R17.11 & draft 

EA2/17 6.2.1)

RESOURCES

7.1 PERSONNEL

Demonstrates a general

understanding of the RED and 

associated documents and 

references.

EU Blue Guide [2014] Access and knowledge of the guide.

RE Directive Knowledge of Directives relevant to NB, shall 

have a copy of the Directive and explain the 

general requirements. 

http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=OJ:JOL_2014_153

_R_0002&from=EN%20

For the RE Directive this should include the 

“effective and efficient” use of the spectrum.

Understands and has a working 

knowledge of the harmonised 

standards as listed in the OJEU.

They should be able to direct you to the RED 

OJEU web page:

If the RED OJEU is not available at the time 

of the assessment then ask for the R&TTE 

OJEU web page which is at:

http://ec.europa.eu/enterprise/policies/europe

an-standards/harmonisedstandards/rtte/index_en.htm

Can correctly explain the date of After the date of cessation of presumption of 
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cessation of presumption of 

conformity in the OJEU listings, 

including equipment in serial 

production?

conformity, all products placed on the market 

shall meet the requirements of the new 

standard, and the DoC must be updated (by 

batch / serial number) to reflect the change.

Can a product be placed on the 

market after the date of cessation 

of presumption of conformity of 

an applied standard?

No, unless / until a comparison of the “old” 

superseded and new standards has been 

performed, and any new / updated 

requirement in the new standard has been 

completed. TCF and DoC will also need to be 

updated.

Which equipment should fall 

within the scope of this Directive?

Whereas (6), Article 1.1, Article 2.1(1).

Which equipment should NOT fall 

within the scope of this Directive?

The equipment detailed in Article 1.3 and 

Annex I

Does Directive 2014/35/EU apply 

to radio equipment?

Whereas (7).

Does Directive 2014/30/EU apply 

to radio equipment?

Whereas (8).

Is there a requirement to “notify 

products” under the RED?

No.

Where do you find individual 

country frequency allocation 

tables?

Referred to in Whereas (24)

Ask to see the frequency allocation for a 

specific country of your choice.

Are domestic animals and / or 

property included in this 

directive?

Yes, Whereas (26) and Article 3.1(a).

What information on intended use 

needs to be supplied?

“Sufficient” – Whereas 30 has more 

guidance.
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What requirements can be used 

to give a presumption of 

conformity?

OJEU listed harmonised standards, see 

whereas (38).

What is the minimum size of the 

CE mark, what is the “general” 

guide?

Whereas (44).

Does CE marking have to appear 

on the packaging, where is this 

requirement given?

Whereas (45).

How did the EU parliament 

express their concern about the 

level of performance of RTTE 

(RED) NBs?

Whereas (49).

Regulation (EC) No 765/2008 Accreditation whereas (52).

Non accredited (53).

Sub Contract (ISO and RED) Whereas (54).

Are public safety (state security) 

radio included in this directive?

No, Art 1.3.

Does equipment under the RED 

also fall under 2014/35/EU?

Only to the level in Article 3.1(a).

Are antenna included in the 

Directive?

Article 2.1(1) definition of radio equipment 

includes antenna.

Article 2.1(7) harmful interference 2002/21/EC clause 2 (r) Harmful interference' 

means interference which endangers the 

functioning of a radio navigation service or of 

other safety services or which otherwise 

seriously degrades, obstructs or repeatedly 

interrupts a radiocommunications service 
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operating in accordance with the applicable 

international, Community or national 

regulations.

Who has responsibility for 

compliance of radio equipment 

with this Directive?

Economic operators: manufacturers, 

importers and distributers.

What checks do you perform 

when assessing a Technical 

construction File?

More than just test reports being presented, 

there must be checks for consistency in 

frequency and radiated power etc. between 

test reports and all the other manufacturer 

supplied documentation, such as user 

manual and technical specifications.

Correct schematics (minimum of Radio 

circuitry from baseband to antenna [port] 

especially reference oscillators, voltage 

regulatory circuits and any shielding for the 

RF areas). 

The TCF must detail how they have dealt with 

tested and untested variants.

TCF content checklist (or actual documentary 

surveillance of a submitted file) must meet 

the requirements of Article 21 and Annex V of 

the RE Directive.

If the TCF is updated to show compliance to 

updated standards, and the product has not 

been re-tested, has a justification been added 

to the TCF.

What checks do you perform 

when assessing a Technical 

construction File?

Ask what process they use to ensure the 

equipment in the report was at the normal 

operating power and compared with the 

manufacturers declared power.

Was it tested in a “typical” operating mode, 
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who chose it (lab, manufacturer?) does it 

seem reasonable?

Do the Schematics include component values 

(at least for the baseband to RF chain) or a 

Bill of materials?

How were untested or partiality test variants 

of the main product assessed. Does the NB 

have enough technical knowledge to assess 

if the variants have been realistically 

assessed as untested or partially tested, and 

other results being acceptable from the main 

fully tested product?

A comparison of the old and new version of 

the standards should be included, explaining 

why no further testing was performed, or why 

only partial testing was performed:

- No further testing if no technical 

changes and the product has not 

changed

Partial testing where a limit has changed, or a 

new test or test method is required, but no 

changes to the hardware.

What checks do you perform when 

assessing an EU Declaration of 

Conformity?

EU Declaration of Conformity [DoC] NB 

should refer to Annex VI or a detailed 

checklist based on Annex VI.

The DoC with must include the correct 

standards (including date of standard or 

version number).

Understands and has a working 

knowledge of the ETSI standards 

system.

1. Demonstrate access to the 

ETSI published standards?

2. How do they access 

information/standard for new 

1. Via http://www.etsi.org/ should be able to 

check the requirements of the [ETSI] 

standard against the test reports.

2. Via http://portal.etsi.org/home.aspx and 
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equipment and technology?

3. Explain the difference between 

ETSI Standards, ETSI 

harmonised standards and the 

standards listed in the OJEU?

demonstrate their ETSI log on. This access 

is needed when assessing product(s) that 

have not followed harmonised “OJEU” 

standards, such as ETSI draft versions that 

are still with the drafting group.

If access is not possible, ask how they 

demonstrate access for any draft updates of 

standards to see if they include new 

technologies they may be assessing (this can 

be one of the reasons for a NB to be 

involved, testing to a draft standard which is 

not yet public domain).

3. Presumption of conformity comes from 

OJEU listed standards only. ETSI 

harmonised standards not listed in the OJEU 

do not give a presumption of conformity.

Understands and has a working 

knowledge of the ECO frequency 

allocation system for EU countries.

Demonstrate access to the EFIS 

web site, (http://www.efis.dk).

Demonstrate access to the EFIS web site. 

Chose a frequency and ask then to explain 

which technology / technologies can use it?

Understands and has a working 

knowledge of Class 1 and class 2 

requirements?

Can go to EU web site, and 

explain the differences. Review 

at least on subclass and explain 

the limitations, can these be 

exceeded by a NB?

Ensure no alert symbol for RED, however 

frequency and power to be listed (Article 10 

clause 8).

RED Article 3.1(a)

Understands and has a working 

knowledge of RF Exposure 

requirements

Explain which standards could be

applied.

Explain SAR, head, body and 

extremity requirements.

Refer to OJEU listing for Article 3.1(a) – if the 

RED OJEU listing is not available, use the 

RTTE one for the assessment – the listing is 

likely to be the same.
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Explain measured and calculated 

requirements.

RED Article 3.1(a)

Understands and has a working 

knowledge of LVD requirements

(very basic explanations in this initial 

document)

Explain the difference to the 

“standard” LVD requirements.

Explain creepage and clearance.

Explain creepage and clearance 

with reference a module 

integration.

Explain creepage and clearance 

with reference module 

integration.

Explain temperature limitations 

when incorporating a module into 

a final host (measured and 

component ratings).

Explain critical components list.

No lower voltage limit. Removes the 

exclusion from assessment for most low 

voltage devices, ask if this change is checked 

and recorded when reviewing LVD test 

reports.

Although a module can be assessed in itself, 

it needs a further assessment when 

integrated into the host as clearance 

distances may be reduced etc.

All components have a maximum 

temperature rating. Need to review the 

temperature when the overall equipment is at 

the maximum and minimum temperature 

range. 

A Module installed will probably be affected 

by heat from other components within the 

final enclosure.

Typical safety critical components are, but not 

limited to, – Power supplies, transformers, Xcaps, Y-Caps, resistors that bridge insulation, 

optocouplers, surge suppression devices, 

mains filters, mains switches, mains inlets/ 

outlets, fuses, thermal cut-outs, safety 

interlocks, mains lead etc.
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The R&TTE CA have had some 

recent discussions on safety, and the 

following documents should be 

available to the NB

“R&TTECA (14)52a German Ad Hoc 

Working Group on Safety 

Assessment Result Table 2014-12-

08”

And 

“R&TTECA (14)52b Safety 

Assessment German Notified Bodies 

RTTE CA Munich 2014-12-08rev01”

The NB should be able to 

produce these documents 

(downloaded from the CIRCABC 

web site or via alternative means) 

and discuss how they apply the 

content

RED Article 3.1(b)

Understands and has a working 

knowledge of EMC requirements

Explain the most common EMC 

standards for wireless devices.

What is an “ancillary device” as 

stated in EN 301 489-1?

Explain performance criteria and 

how it is monitored for wireless 

devices. Is this checked for 

applicability in the reports?

Ask what standards need to be 

applied when a wireless device is 

added to another product, such 

as a TV or Fridge.

Must be able to refer to ETSI 301 489-X

series

Reference: ETSI EN 301 489-1 Annex C

RED Article 3.2

Understands the efficient and 

effective use requirement

Explain the general requirements 

for efficient and effective use. 

Can demonstrate a working 

knowledge of co-existence issues 

and considerations when dealing 

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 will require receiver performance 

assessment as well as the transmit 
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with products using new 

technologies that are not covered 

by harmonised standards.

Can demonstrate technical 

knowledge to assess product 

variants (such as RF path) 

changes.

Understands and has a working 

knowledge of equipment types 

requiring DFS and the DFS test 

requirements.

Review at least one recent NB 

Opinion

characteristics. This is one of the changes 

from the RED compared to the R&TTE 

Directive.

Should know where to find and be able to 

explain SRDocs, the function of CEPT and 

the interaction with ETSI and, for extreme 

cases, SEAMCAT.

RF circuit knowledge sufficient to evaluate 

design and design changes, effects of tracks 

and component changes in RF path.

Standards requiring DFS functionality. What 

do they expect to see to demonstrate that it 

cannot be disabled; how to demonstrate new 

firmware cannot disable DFS or expand 

frequency range outside the limits for EU.

For 2015, a recent TCF should be evaluated. 

a) Do the recent (2015) R&TTE NB Opinion 

include an expiry date (latest should be 13th

June 2017) 

b) do they have a process to remind their 

customers to update their TCFs and 

associated and NB documents if applicable 

(not compulsory)

RED Article 3.3.i Understands and has a working 

knowledge of the software 

requirements, in and for, radio 

equipment?

Requirement to ask what features the 

manufacturer is expected to have 

implemented to enforce this statement. 

Article 26.6

A conformity assessment body shall 

Appropriate experience to 

perform the conformity 
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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) personnel with technical 

knowledge and sufficient and 

appropriate experience to perform 

the conformity assessment tasks.

(768/2008 Article R17.6(a) & draft 

EA2/17 7.1.1)

assessment tasks?

What technical knowledge do 

they require of staff to perform 

the conformity assessment 

tasks? How does this 

demonstrate that the required 

level is sufficient?

What do they consider is 

appropriate experience to 

perform the conformity 

assessment tasks?

Where are the details of the 

above recorded for each NB team 

member?
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Article 26.7 “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 Article 3, of 

the applicable harmonised standards 

and of the relevant provisions of 

Union harmonisation legislation and 

of national legislation; 

(d) the ability to draw up EU-type 

examination certificates or quality 

system approvals, records and 

reports demonstrating that 

assessments have been carried out.” 

(768/2008 Article R17.7 & draft 

EA2/17 7.1.2)

What do they require as “sound 

technical and vocational 

training”?

What do they require for staff 

dealing with the “rubber stamp” 

jobs (use of harmonised 

standards only)?

What do they require for staff 

dealing with jobs that involve the 

assessment where harmonised 

standards have not been used, or 

only used on part?

What is their requirement to 

assess a satisfactory level of 

knowledge?

When must a manufacturer use a 

NB?

A1) Degree + 3 years relevant experience or 

7 years relevant experience (what is relevant 

experience, testing, compliance engineer?) A 

test engineer or compliance engineer may not 

have the knowledge of standards 

development, spectrum sharing studies, or a 

basic knowledge of RF circuitry in order to 

evaluate designs, if needed.

A2) as A1) + knowledge of RF circuit design 

[filters, impedance matching, VSWR etc.], 

ETSI working group activities (via ETSI 

portal), CEPT and ERO, SRDocs, Coexistence studies and typical ETSI standards 

requirements including those for receiver 

parameters.

Only if the manufacturer has not used 

harmonised standards (in full) for article 3.2. 

A NB opinion is not required for Article 3.1(a) 

or Article 3.1(b) regards if the manufacturer 

has used harmonised standards or not. 

Does the EU Type Examination Certificate 

cover the details required under the Directive.

7.2 EQUIPMENT
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Article 26.6

A conformity assessment body shall 

be capable of carrying out all the 

conformity assessment tasks 

assigned to it by Annexes III and IV 

in relation to which it has been 

notified, whether those tasks are 

carried out by the conformity 

assessment body itself or on its 

behalf and under its responsibility.

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.

(768/2008 Article R17.6 & draft 

EA2/17 7.2.1)

Review to see if this requirement 

is met?

7.3 OUTSOURCING

Article 28 

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.

(768/2008 Article R20.1 & draft 

Does the NB subcontract any 

portion of the work for this 

Directive?

Does the NB have a subsidiary 

that performs any part of the 

assessment?

If yes to either, how do they ensure the 

subsidiary / subcontractor meet the 

requirements set out in article 26 and those 

under the relevant ISO 17020 / 17065 

accreditation. They shall produce the 

documentary evidence to support this.
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EA2/17 7.3.1)

Article 28 

Notified bodies shall take full 

responsibility for the tasks performed 

by subcontractors or subsidiaries 

wherever these are established.

(768/2008 Article R20.2 & draft 

EA2/17 7.3.2)

Article 28 

Activities may be subcontracted or 

carried out by a subsidiary only with 

the agreement of the client.

(768/2008 Article R20.3 & draft 

EA2/17 7.3.3)

Article 28 

Notified bodies shall keep at the 

disposal of the notifying authority the 

relevant documents concerning the 

assessment of the qualifications of 

the subcontractor or the subsidiary 

and the work carried out by them 

under Annexes III and IV

(768/2008 Article R20.4 & draft 

EA2/17 7.3.4)

INFORMATION REQUIREMENTS & CONFIDENTIALITY

8.1 INFORMATION REQUIREMENTS

Article 36.1 Review process / procedure and 
V1.0c December 2014

Notified bodies shall inform the 

notifying authority of the following:

(a) any refusal, restriction, 

suspension or withdrawal of an EUtype 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.

(768/2008 Article R28.1 & draft 

EA2/17 8.1.1)

Contract as applicable

Article 36.2

Notified bodies shall, in accordance 

with the requirements of Annexes III 

and IV, provide the other bodies 

notified under this Directive carrying 

out similar conformity assessment 

activities covering the same 

categories of radio equipment with 

relevant information on issues 

relating to negative and, on request, 

positive conformity assessment 

A process is under development 

of the RTTE CA (RED CA) and 

will be available to all members. 

Member of the RTTE CA (RED 

CA) will provide a presumption of 

meeting this requirement.

Documented alternatives for nonmembers shall be required. 

What data is sent for the “request 

positive conformity assessment 

results”

Typically technical parameters of the 

evaluated equipment. (Typically noncommercial information).
V1.0c December 2014

results.

(768/2008 Article R28.2 & draft 

EA2/17 8.1.2)

How do they check the request is 

from another Notified Body?

Refer to NANDO database for email address 

of NB.

8.2 CONFIDENTIALITY

Article 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.

(768/2008 Article R17.10 & draft 

EA2/17 8.2.1)

Is this part of their contract of 

employment (review contract) or 

a supplementary contract for the 

specific role (review)?

Do they have a specific contract 

with the manufacturer stating the 

requirement to supply documents 

to the National Authority on 

reasoned request?

PROCESS REQUIRMENTS

9.1 GENERAL

Acceptance of test data Is there a mechanism or 

procedure in place to accept test 

data from an external testing 

laboratory?

What rules are in place for the 

acceptance of test data? What is 

the basis upon which the rules 

It should be considered acceptable to perform 

a reduced level of checking on a 17025 

accredited report from a country under ILAC. 

The reduced level still needs to include 

checking the product details and the correct 

test cases have been applied, and noting any 

parameters which are passes within 
V1.0c December 2014

give confidence in the test data?

Are these rules applied 

consistently? Is there a 

differentiation between ISO 

17025 accredited reports and 

non-accredited reports? If so 

what is the process?

measurement uncertainty as this may affect 

the future compliance of the product. The 

Certificate should comment on parameters 

within measurement uncertainties.

Where the reports are NOT 17025 then a far 

more detailed review of them should be 

performed, including checks of the equipment 

calibration (copies of calibration certificates), 

estimates of measurement uncertainties (if 

measurements are close to the limits) and a 

review of the CV of the person performing the 

testing (to assess if they are likely to be 

competent to perform the test).

Article 26.6

A conformity assessment body shall 

be capable of carrying out all the 

conformity assessment tasks 

assigned to it by Annexes III and IV 

in relation to which it has been 

notified, whether those tasks are 

carried out by the conformity 

assessment body itself or on its 

behalf and under its responsibility.

(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;

Review procedures to see if this 

requirement is met.
V1.0c December 2014

(768/2008 Article R17.6(b) & draft 

EA2/17 9.1.2)

Article 26.6

A conformity assessment body shall 

be capable of carrying out all the 

conformity assessment tasks 

assigned to it by Annexes III and IV 

in relation to which it has been 

notified, whether those tasks are 

carried out by the conformity 

assessment body itself or on its 

behalf and under its responsibility.

(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.

(768/2008 Article R17.6(c) & draft 

EA2/17 9.1.2)

Review procedures to see if this 

requirement is met.

9.2 SCOPE
V1.0c December 2014

9.3 OPERATIONAL OBLIGATIONS

Article 34.1

Notified bodies shall carry out 

conformity assessments in 

accordance with the conformity 

assessment procedures provided for 

in Annexes III and IV.

(768/2008 Article R17.1 & draft 

EA2/17 9.3.1)

Request to see procedures and 

review against Annexes III and/or 

Annex IV depending on the scope 

of the NB.

Article 34.2 

Conformity assessments shall be 

carried out in a proportionate 

manner, avoiding unnecessary 

burdens for economic operators. 

Conformity assessment bodies shall 

perform their activities taking due 

account of the size of an undertaking, 

the sector in which it operates, its 

structure, the degree of complexity of 

the radio equipment technology in 

question and the mass or serial 

nature of the production process. 

In so doing they shall nevertheless 

respect the degree of rigour and the 

level of protection required for the 

compliance of the radio equipment 

with this Directive.”

(768/2008 Article R27.2 & draft 

EA2/17 9.3.2)

Review procedure to ensure 

additional requirements above 

those in the Directive (or their 

country National Legislation) is 

not being imposed on the 

customers. 

Article 34.3

Where a notified body finds that the 

Review process / procedure and 

contract as applicable.

Any new product, even from the same series 

of production, shall be assessed against the 

newer version of the Standard. This may 
V1.0c December 2014

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.

(768/2008 Article R27.3 & draft 

EA2/17 9.3.3)

only need a paperwork exercise to compare 

the standards if there are no hardware / 

software changes to the product. There may 

be a need for partial testing or on some cases 

full testing. The TCF and DoC must also be 

updated.

If Annex IV, must be reviewed. What about 

“normal” where NB issues certificate???

Article 34.4

Where, in the course of the 

monitoring of conformity following the 

issue of an EU-type examination 

certificate or a quality system 

approval, a notified body finds that 

radio equipment no longer complies; 

it shall require the manufacturer to 

take appropriate corrective measures 

and shall suspend or withdraw the 

EU-type examination certificate or the 

quality system approval if necessary.

(768/2008 Article R27.4 & draft 

EA2/17 9.3.4)

Review process / procedure and 

Contract as applicable.

What does monitoring mean in practice?

Article 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.
V1.0c December 2014

(768/2008 Article R27.5 & draft 

EA2/17 9.3.5)

Article 36.3

Notified bodies shall fulfil information 

obligations under Annexes III and IV.

(768/2008 Article R28.3 & draft 

EA2/17 9.3.1)

As applicable – not all NB will be 

Annex IV

9.4 CONFORMITY ASSESSMENT CRITERIA

9.5 PREPARATION FOR ASSESSMENT AND CONTRACT REVIEW

9.6 ASSESSMENT

Article 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.

How does the NB plan to 

check the equipment can be 

used in at least one country 

when new technology is in the 

equipment?

If product complies, in full, with Article 3.2 

harmonised standards, with no deviations.

Checks on the EFIS database.

Possible to contact with at least one National 

Authority, within the EU, who agree it can be 

placed on the market on their country.

Article 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 

The NB shall show where they 

record these have been (or will 

be) checked. 

Where there is a restriction this 

should be noted on the EU 

type examination certificate.
V1.0c December 2014

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...”

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).

What does the NB actually do 

when performing an 

assessment, (the wording 

infers more than reviewing 

reports)?

How is the NB process 

described within the 

management system?

Is there a procedure describing 

the process in sufficient detail 

to ensure consistency of 

application?

No requirement to examine a physical 

sample, review of technical document and 

supporting evidence.

Annex III Module B.3

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 

The NB shall demonstrate how 

they record that these specific 

application requirements have 

been met. 

How is the assessment of the 

application recorded? The NB 

shall demonstrate how they 

record that these specific 

application requirements have 

been met.

Note the reference to Annex V, the 

requirements to check this should be part of 

their checklist or procedure.
V1.0c December 2014

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

The notified body shall examine the 

technical documentation and supporting 

evidence to assess the adequacy of the 

technical design of the radio equipment

What skills do they check to 

assess adequacy (may refer to 

earlier items in this guide)?
V1.0c December 2014

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.

Review NB Procedure(s).

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 EU-type examination 

certificate to the manufacturer. 

1. That certificate shall contain the 

name and address of the 

manufacturer, the conclusions of 

the examination, 

2. the aspects of the essential 

requirements covered by the 

examination, 

3. the conditions (if any) for its 

validity and the necessary data 

for identification of the assessed 

type. 

The EU-type examination certificate 

may have one or more annexes 

attached.

4. The EU-type examination 

certificate and its annexes shall 

contain all relevant information to 

The Certificate (or template 

Certificate) shall be checked 

for points 1 to 4.

Standards by version number
V1.0c December 2014

allow the conformity of 

manufactured radio equipment 

with the examined type to be 

evaluated and to allow for inservice 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.

or date

In-service control 

(measurements within 

uncertainties?).

Where is this documented?

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 

Such as OJEU list and notes, 

R&TTE CA and replacement, 

CEPT, ECO, ETSI Standards, 

ETSI WG activities....ADCO

(and continuing education 

records relevant for the role)

Where is this in their

procedure?

This requirement needs to be 

demonstrated, (Contract?).
V1.0c December 2014

addition to the original EU-type 

examination certificate.

Annex III Module B.8

Each notified body shall inform its notifying authority 

concerning the EU-type examination certificates 

and/or any additions thereto which it has issued or 

withdrawn, and shall, periodically or upon request, 

make available to its notifying authority the list of 

such certificates and/or any additions thereto 

refused, suspended or otherwise restricted. 

Each notified body shall inform the other notified 

bodies concerning the EU-type examination 

certificates and/or any additions thereto which it has 

refused, withdrawn, suspended or otherwise 

restricted, and, upon request, concerning such 

certificates and/or additions thereto which it has 

issued. 

Each notified body shall inform the Member States of 

EU-type examination certificates it has issued and/or 

additions thereto in those cases where 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. 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 

Procedure?

Records?

How?

(could be a list of NBs 

with email 

addresses?)

What should be 

included in the email

(Standards and failing 

parameters only?)

Email list of member 

states? Via ADCO? 

EU Commission?

Contract with 

customer to state this 
V1.0c December 2014

by the manufacturer for 10 years after the radio 

equipment has been assessed or until the expiry of 

the validity of that certificate.

is a legal 

requirement??

How does the NB 

ensure the files will 

be available for 10 

years??

Annex III Module 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 radio equipment has been placed on the market.

How has the NB 

made sure the 

Manufacturer is 

aware of the 

requirement?

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.

If applicable, how 

is this recorded?

Add in Annex IV module H checks ONLY FOR Annex 4, FQA. This will typically 

require a site visit to a current R&TTE Annex 

5 customer for the assessment, or an initial 

assessment with a new customer for Annex 4 

of the Radio equipment Directive.

1. Conformity based on full quality assurance is the 

conformity assessment procedure whereby the 

manufacturer fulfils the obligations laid down in points 

2 and 5, and ensures and declares on his sole 

responsibility that the radio equipment concerned 

satisfies the requirements of this Directive that apply 
V1.0c December 2014

to it

2. Manufacturing 

The manufacturer shall operate an approved quality 

system for design, manufacture, final radio 

equipment inspection and testing of the radio 

equipment concerned as specified in point 3 and 

shall be subject to surveillance as specified in point 4.

3. Quality system 

3.1. The manufacturer shall lodge an application for 

assessment of his quality system with the notified 

body of his choice, for the radio equipment 

concerned. 

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) the technical documentation for each radio 

equipment type intended to be manufactured. The 

technical documentation shall contain, wherever 

applicable, the elements set out in Annex V; 

(c) the documentation concerning the quality system; 

and 

(d) a written declaration that the same application 

has not been lodged with any other notified body.

3.2. The quality system shall ensure compliance of 

the radio equipment with the requirements of this 

Directive that apply to it. 

All the elements, requirements and provisions 
V1.0c December 2014

adopted by the manufacturer shall be documented in 

a systematic and orderly manner in the form of 

written policies, procedures and instructions. That 

quality system documentation shall permit a 

consistent interpretation of the quality programmes, 

plans, manuals and records. 

It shall, in particular, contain an adequate description 

of: 

(a) the quality objectives and the organisational 

structure, responsibilities and powers of the 

management with regard to design and product 

quality; 

(b) the technical design specifications, including 

standards, that will be applied and, where the 

relevant harmonised standards will not be applied in 

full, the means that will be used to ensure that the 

essential requirements of this Directive that apply to 

the radio equipment will be met; 

(c) the design control and design verification 

techniques, processes and systematic actions that 

will be used when designing radio equipment 

pertaining to the radio equipment type covered; 

(d) the corresponding manufacturing, quality control 

and quality assurance techniques, processes and 

systematic actions that will be used; 

(e) the examinations and tests that will be carried out 

before, during and after manufacture, and the 

frequency with which they will be carried out; 

(f) the quality records, such as inspection reports and 

test data, calibration data, reports concerning the 

qualifications of the personnel, etc.; 

(g) the means of monitoring the achievement of the 

required design and product quality and the effective 
V1.0c December 2014

operation of the quality system.

3.3. The notified body shall assess the quality 

system to determine whether it satisfies the 

requirements referred to in point 3.2. 

It shall presume conformity with those requirements 

in respect of the elements of the quality system that 

comply with the corresponding specifications of the 

relevant harmonised standard. 

In addition to experience in quality management 

systems, the auditing team shall have at least one 

member experienced as an assessor in the relevant 

radio equipment field and radio equipment 

technology concerned, and knowledge of the 

applicable requirements of this Directive. The audit 

shall include an assessment visit to the 

manufacturer's premises. The auditing team shall 

review the technical documentation referred to in 

point 3.1(b) to verify the manufacturer's ability to 

identify the applicable requirements of this Directive 

and to carry out the necessary examinations with a 

view to ensuring compliance of the radio equipment 

with those requirements. 

The manufacturer or his authorised representative 

shall be notified of the decision. 

The notification shall contain the conclusions of the 

audit and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the 

obligations arising out of the quality system as 

approved and to maintain it so that it remains 

adequate and efficient.

3.5. The manufacturer shall keep the notified body 

that has approved the quality system informed of any 
V1.0c December 2014

intended 

change to the quality system. 

The notified body shall evaluate any proposed 

changes and decide whether the modified quality 

system will continue to satisfy the requirements 

referred to in point 3.2 or whether a reassessment is 

necessary. 

It shall notify the manufacturer of its decision. The 

notification shall contain the conclusions of the 

examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified 

body 

4.1. The purpose of surveillance is to make sure that 

the manufacturer duly fulfils the obligations arising 

out of the approved quality system.

4.2. The manufacturer shall, for assessment 

purposes, allow the notified body access to the 

design, manufacture, 

inspection, testing and storage sites, and shall 

provide it with all necessary information, in particular: 

(a) the quality system documentation; 

(b) the quality records as provided for by the design 

part of the quality system, such as results of 

analyses, calculations, tests, etc.; 

(c) the quality records as provided for by the 

manufacturing part of the quality system, such as 

inspection reports and test data, calibration data, 

reports concerning the qualifications of the personnel, 

etc.

4.3. The notified body shall carry out periodic audits 

to make sure that the manufacturer maintains and 
V1.0c December 2014

applies the quality system and shall provide the 

manufacturer with an audit report.

4.4. In addition, the notified body may pay 

unexpected visits to the manufacturer. During such 

visits, the notified body may, if necessary, carry out 

radio equipment tests, or have them carried out, in 

order to check the proper functioning of the quality 

system. It shall provide the manufacturer with a visit 

report and, if tests have been carried out, with a test 

report.

5. CE marking and EU declaration of conformity 

5.1. The manufacturer shall affix the CE marking in 

accordance with Articles 19 and 20 and, under the 

responsibility of the notified body referred to in point 

3.1, the latter's identification number to each item of 

radio equipment that satisfies the applicable 

requirements set out in Article 3.

5.2. The manufacturer shall draw up a written EU 

declaration of conformity for each radio equipment 

type and keep it at the disposal of the national 

authorities for 10 years after the radio equipment has 

been placed on the market. The EU declaration of 

conformity shall identify the radio equipment type for 

which it has been drawn up. 

A copy of the EU declaration of conformity shall be 

made available to the relevant authorities upon 

request.

6. The manufacturer shall, for a period ending 10 

years after the radio equipment has been placed on 

the market, keep at the disposal of the national 

authorities: 

(a) the technical documentation referred to in point 
V1.0c December 2014

3.1; 

(b) the documentation concerning the quality system 

referred to in point 3.1; 

(c) the change referred to in point 3.5, as approved; 

(d) the decisions and reports of the notified body 

referred to in points 3.5, 4.3 and 4.4.

7. Each notified body shall inform its notifying 

authority of quality system approvals issued or 

withdrawn, and shall, periodically or upon request, 

make available to its notifying authority the list of 

quality system approvals refused, suspended or 

otherwise restricted. 

Each notified body shall inform the other notified 

bodies of quality system approvals which it has 

refused, suspended or withdrawn, and, upon request, 

of quality system approvals which it has issued.

8. Authorised representative 

The manufacturer's obligations set out in points 3.1, 

3.5, 5 and 6 may be fulfilled by his authorised 

representative, on his behalf and under his 

responsibility, 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:

Check procedures , process for the “Annex V 

checklist” checks.
V1.0c December 2014

(a) a general description of the radio equipment 

including: 

(i) photographs or illustrations showing external 

features, marking and internal layout; 

(ii) versions of software or firmware affecting 

compliance with essential requirements; 

(iii) user information and installation instructions;

(b) conceptual design and manufacturing drawings 

and schemes of components, sub-assemblies, 

circuits and other relevant similar elements;

(c) descriptions and explanations necessary for the 

understanding of those drawings and schemes and 

the operation of the radio equipment;

(d) a list of the 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 
V1.0c December 2014

elements;

(h) test reports;

(i) an explanation of the compliance with the 

requirement of Article 10(2) and of the inclusion or 

not of information on the packaging in accordance 

with Article 10(10).

Annex VI EU DECLARATION OF CONFORMITY (No 

XXX) [DoC}

Check procedures , process for the “DoC ”

content checks.

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

6. References to the relevant harmonised standards 

used or references to the other technical 
V1.0c December 2014

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 checks

SIMPLIFIED EU DECLARATION OF CONFORMITY

Check procedures , process for the 

“Simplified DoC” checks.

The simplified EU declaration of conformity referred 

to in Article 10(9) shall be provided as follows: 

Hereby, [Name of manufacturer] declares that the 

radio equipment type [designation of type of radio 

equipment] is in compliance with Directive 

2014/53/EU. 

The full text of the EU declaration of conformity is 

available at the following internet address: