Conformity Assessment

Conformity assessment
Maureen Logghe
FPS Economie, SME, Self-employed and
Energie
International Strategy
Content
 Legal base and requirements

 Modules
 Notified body
 Notifying authority
 Notification process
http://economie.fgov.be
Legal requirements
Legislation prescribes that the manufacturer needs to

demonstrate that specified requirements related to a
product are fulfilled
= CONFORMITY ASSESSMENT
Legal requirements
 Conformity assessment is a responsibility of the

manufacturer.
 A product is subjected to conformity assessment

both during the design and production phase.
 Should a manufacturer subcontract design or

production, he still remains responsible for the
execution of conformity assessment.
Legal base
 Decision 768/2008
lays down the "horizontal menu" of conformity
assessment modules and the ways procedures are
built of modules
 Legislator
The legislator selects the most appropriate modules in
order to address the specific needs of the concerned
sector . This selection is done taking into account the
type of products and hazards involved, the economic
infrastructures of the given sector, the methods of
production etc
 There are eight modules (named with the letters
from A to H)
 They lay down the responsibilities of the

manufacturer and the degree of involvement of the
in-house accredited or notified conformity
assessment body
Different possibilities of procedures
Notified Body
 Notified Body is a Conformity Assessment Body

(CAB) designated by Member State under a NA
legislation
 Procedure to notify is made publicly available

http://ec.europa.eu/enterprise/newapproach/nando/in
dex.cfm?fuseaction=na.detail&na_id=215945
Notified Body
 A notified body examines the technical design of a

type and verifies and attests that it meets the
requirements of the legislative instrument that apply
to it by issuing an EU-type examination certificate.
 There are 3 ways to carry out EU-type examination:

1)production type,
2) combination of production type and design
type and
3) design type
Notified Body
 Notified bodies are free to offer their conformity

assessment services, within their scope of
notification, to any economic operator established
either inside or outside the Union. They may carry
out these activities also on the territory of other
Member States or of third countries.
 Although the notified body must be established on

the territory of the notifying Member States, it may
have activities or personnel outside the Member
State, or even outside the Union
Notified Body
 Notified bodies must operate in a competent, non-

discriminatory, transparent, neutral, independent
and impartial manner
 Notified bodies must provide relevant information to

their notifying authority, the market surveillance
authorities and other notified bodies
Notified Body
 In no circumstances should the notified body issue

a test report carrying its notified body number in
relation to tests that are not specified in the
legislation, whether those tests were carried out by
the body itself or by another body.
 Moreover, a notified body may only use its number

in relation to conformity assessment activities
carried out under the specific conformity
assessment module that requires the intervention of
a notified body, and for which it has been notified
Notified Body
 They assess according to the requirements of the

NA legislation
 They can not deliver a partial certificate
 Certificate needs to be reevaluated
Notifying Authority
• A notifying authority is the governmental or public

body that is tasked with designating and notifying
conformity assessment bodies under Union
harmonisation legislation
• Each Member State must designate a notifying
authority to be responsible for the assessment,
notification and monitoring of conformity
assessment body
 The notifying authority assumes full responsibility
for the competence of the bodies it notifies
Notifying Authority
• no conflict of interest with CAB

• safeguard the objectivity and impartiality of their
activities
• must not offer or provide any activities that CAB
perform, or consultancy services on a commercial
or competitive basis.
• must safeguard the confidentiality of the
information it obtains
Notification process
 Notification is the act of the NA informing the

Commission and the other Member States that a
CAB has been designated to carry out conformity
assessment according to a Union harmonisation
act, and fulfils the requirements relating to notified
bodies set out in that Union harmonisation act
 Accreditation is the preferred way to assess the
technical competence of notified bodies (mandatory
in Belgium)
 Sent via NANDO
http://ec.europa.eu/growth/single-
market/goods/index_en.htm
Conformity assessment key elements
 Modules
 Notified Bodies
 Quality assurance
 Technical file
 EC Declaration of conformity
 CE marking
 Free movement of goods in Single Market
LATVIJAS REPUBLIKAS EKONOMIKAS MINISTRIJA

MINISTRY OF ECONOMICS OF THE REPUBLIC OF LATVIA
Technical file (technical documentation)
 Prepared and kept by manufacturer
 Provides information on the design, manufacture
and operation of the product
 The detailed requirements are defined in each
directive
 Must be available to authorities and Notified Bodies

EC Declaration of conformity
 Drawn up and signed by the manufacturer or
the authorised
 must contain all relevant information to
identify the Union harmonisation legislation
according to which it is issued, as well as the
manufacturer, the authorised representative,
the notified body if applicable, the product,
and where appropriate a reference to
harmonised standards or other technical
specifications. LATVIJAS REPUBLIKAS EKONOMIKAS MINISTRIJA
EC Declaration of conformity
 A single declaration of conformity is required
whenever a product is covered by several
pieces of Union harmonisation legislation
requiring an EU Declaration of Conformity
 The single declaration of conformity can be
made up of a dossier containing all relevant
individual declarations of conformity

EC Declaration of conformity model
1. A number identifying the product. This number does not need to be unique to each product. It could
refer to a product, batch, type or a serial number. This is left to the discretion of the manufacturer.
2. The name and address of the manufacturer or the authorised representative issuing the declaration.
3. A statement that the declaration is issued under the sole responsibility of the manufacturer.
4. The identification of the product allowing traceability. This is basically any relevant information
supplementary to point 1 describing the product and allowing for its traceability. It may where relevant
for the identification of the product contain an image, but unless specified as a requirement in the
Union harmonisation legislation this is left to the discretion of the manufacturer.
5. All relevant Union harmonisation legislation complied with; the referenced standards or other
technical specifications (such as national technical standards and specifications) in a precise,
complete and clearly defined way; this implies that the version and/or date of the relevant standard is
specified.
6. The name and identification number of the notified body when it has been involved in the conformity
assessment procedure211 212 and the reference to the relevant certificate, if applicable.
7. All supplementary information that may be required (for example grade, category), if applicable.
8. The date of issue of the declaration; signature and title or an equivalent marking of authorised
person; this could be any date after the completion of the conformity assessment

CE marking
Affixed by the manufacturer (or his authorised
representative) on own responsibility:
 indicates the conformity of the product with the
Union legislation applying to the product and
providing for CE marking
 The CE marking is affixed on products that will be
placed on the EEA and Turkish market, whether
they are manufactured in the EEA, in Turkey or in
another country.
CE marking
 Regulation (EC) No 765/2008 lays down the
general principles governing the CE marking
while Decision No 768/2008/EC provides for
rules governing its affixing.
 Sectoral Union harmonisation texts providing
for CE marking are based on Regulation (EC)
No 765/2008 and Decision No 768/2008/EC.

THE MANUFACTURER’S
RESPONSIBILITIES UNDER THE NEW
AND GLOBAL APPROACH ARE TO...
 Ensure compliance with essential requirements of
the Directive(s)
 Use appropriate conformity assessment modules
 Choose appropriate notified Body
 Establish a technical file
 Draw up EC declaration of conformity
 Affix the CE marking as the final sign of conformity
Abbreviations
 EU = European Union
 FPS = Federal Public Service
 DG = Directorate General
 CAB = Conformity assessment body
 NA = New approach
 NA = Notifying authority
Interesting link
economie.fgov.be/veiligheid
 Consolidated legislation
 Interpretation on legislation
 Reports on market surveillance campaigns
 Interesting documents
Maureen Logghe
Office of the President
International strategy
City Atrium C
Vooruitgangstraat 50
1210 Brussel
T +32 (0) 2 277 87 96

maureen.logghe@economie.fgov.be
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Conformity assessment

 Legal base and requirements

Legislation prescribes that the manufacturer needs to

 Conformity assessment is a responsibility of the

 A product is subjected to conformity assessment

 Should a manufacturer subcontract design or

 They lay down the responsibilities of the

 Notified Body is a Conformity Assessment Body

 Procedure to notify is made publicly available

 A notified body examines the technical design of a

 There are 3 ways to carry out EU-type examination:

 Notified bodies are free to offer their conformity

 Although the notified body must be established on

 Notified bodies must operate in a competent, non-

 Notified bodies must provide relevant information to

 In no circumstances should the notified body issue

 Moreover, a notified body may only use its number

 They assess according to the requirements of the

• A notifying authority is the governmental or public

• no conflict of interest with CAB

 Notification is the act of the NA informing the

LATVIJAS REPUBLIKAS EKONOMIKAS MINISTRIJA

LATVIJAS REPUBLIKAS EKONOMIKAS MINISTRIJA

LATVIJAS REPUBLIKAS EKONOMIKAS MINISTRIJA

LATVIJAS REPUBLIKAS EKONOMIKAS MINISTRIJA

LATVIJAS REPUBLIKAS EKONOMIKAS MINISTRIJA

T +32 (0) 2 277 87 96

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