Guide to the implementation of directives based on the New ...

❝ Notified bodies ❞
Notified bodies are designated <strong>to</strong> assess
<strong>the</strong> conformity with <strong>the</strong> essential requirements,
and <strong>to</strong> ensure consistent technical
● The primary task <strong>of</strong> a notified body is <strong>to</strong> provide services
application <strong>of</strong> <strong>the</strong>se requirements according
for conformity assessment on <strong>the</strong> conditions set out in <strong>the</strong>
<strong>to</strong> <strong>the</strong> relevant procedures in <strong>the</strong> <strong>directives</strong>
concerned. The notified bodies must have <strong>directives</strong>. This is a service <strong>to</strong> <strong>the</strong> manufacturers in an area
appropriate facilities that enable <strong>the</strong>m <strong>to</strong> <strong>of</strong> public interest.
carry out technical and administrative tasks ● Notified bodies are free <strong>to</strong> <strong>of</strong>fer <strong>the</strong>ir conformity assessment
related <strong>to</strong> conformity assessment. They services, within <strong>the</strong>ir scope <strong>of</strong> notification, <strong>to</strong> any economic
must also apply appropriate procedures <strong>of</strong> opera<strong>to</strong>r established ei<strong>the</strong>r inside or outside <strong>the</strong> Community.
quality control in relation <strong>to</strong> such services
They may carry out <strong>the</strong>se activities also on <strong>the</strong> terri<strong>to</strong>ry <strong>of</strong>
provided.
o<strong>the</strong>r Member States or <strong>of</strong> third countries.
The conformity assessment procedures
have been divided in<strong>to</strong> a set <strong>of</strong> sep-
● Manufacturers are free <strong>to</strong> choose any notified body that has
arate modules, which cannot be fur<strong>the</strong>r been designated <strong>to</strong> carry out <strong>the</strong> conformity assessment procedure
in question according <strong>to</strong> <strong>the</strong> applicable directive.
subdivided without putting in<strong>to</strong> question <strong>the</strong>
coherence <strong>of</strong> <strong>the</strong> system and <strong>the</strong> responsibilities
which should lie with <strong>the</strong> manufacturer
and, where applicable, <strong>the</strong> notified bodies. This authorised representative regarding <strong>the</strong> directive in question,
apply <strong>the</strong> conformity assessment procedure without
means that a notified body must be capable <strong>of</strong> taking <strong>the</strong>
responsibility and have <strong>the</strong> competence <strong>to</strong> carry out <strong>the</strong> unnecessary burdens for <strong>the</strong> economic opera<strong>to</strong>rs, and
conformity assessment according <strong>to</strong> a complete module refrain from proposing additional certification or marking
or for several complete modules. Consequently, <strong>the</strong> body that has no added value ( 116 ).
cannot be notified for part <strong>of</strong> a module. For instance, as To avoid unnecessary burdens for economic opera<strong>to</strong>rs,
<strong>the</strong> technical documentation provided <strong>to</strong> notified bod-
regards <strong>the</strong> module Hbis a body may not be notified <strong>to</strong>
deal with <strong>the</strong> design phase only. Fur<strong>the</strong>r, a body notified ies has <strong>to</strong> be limited <strong>to</strong> that which is required solely for <strong>the</strong>
for modules D, E, H or <strong>the</strong>ir variants must be capable <strong>of</strong> purpose <strong>of</strong> assessing conformity <strong>to</strong> <strong>the</strong> <strong>directives</strong>. Fur<strong>the</strong>r,
taking <strong>the</strong> responsibility not only for <strong>the</strong> aspects <strong>of</strong> <strong>the</strong> a quality system approved by a notified body or an accredited
certification body should be taken in<strong>to</strong> account
quality systems involved but also for product-related
requirements. In ei<strong>the</strong>r case <strong>the</strong> notified body may subcontract
some <strong>of</strong> <strong>the</strong> operations ( 115 ).
when <strong>the</strong> same or any o<strong>the</strong>r notified body is carrying out
conformity assessment according <strong>to</strong> modules D, E, H, or
A notified body wishing <strong>to</strong> <strong>of</strong>fer services according <strong>to</strong>
<strong>the</strong>ir variants, ei<strong>the</strong>r for <strong>the</strong> same or ano<strong>the</strong>r product category.
In such cases, however, <strong>the</strong> notified body should
several conformity assessment procedures must fulfil <strong>the</strong>
relevant requirements for <strong>the</strong> respective tasks, and this has
check that <strong>the</strong> certificate covers <strong>the</strong> applicable provisions
<strong>to</strong> be assessed according <strong>to</strong> <strong>the</strong> requirements for each
<strong>of</strong> <strong>the</strong> directive. It should also consider whe<strong>the</strong>r or not it
different procedure in question. However, since <strong>the</strong> scope
is necessary <strong>to</strong> require appropriate supplementary audits
<strong>of</strong> most New Approach <strong>directives</strong> can be relatively wide
specifically relating <strong>to</strong> <strong>the</strong> (new) product category, although
<strong>the</strong>re is <strong>of</strong>ten no need <strong>to</strong> fully duplicate <strong>the</strong> quality
and heterogeneous, a notified body need not be qualified
<strong>to</strong> cover all products falling within its scope, just a
system approval as such.
defined range <strong>of</strong> products within its scope.
Although <strong>the</strong> notified body must be established on <strong>the</strong>
Notified bodies shall have appropriate structures and
procedures <strong>to</strong> ensure that <strong>the</strong> conduct <strong>of</strong> conformity
terri<strong>to</strong>ry <strong>of</strong> <strong>the</strong> notifying Member States, it may have activities
or personnel outside <strong>the</strong> Member State, or even outside
assessment and <strong>the</strong> issuing <strong>of</strong> certificates are subject <strong>to</strong> a
review process. Relevant procedures must, in particular, <strong>the</strong> Community. Certificates are, however, always issued by
cover obligations and responsibilities in relation <strong>to</strong> suspension
and withdrawal <strong>of</strong> certificates, requests addressed <strong>to</strong> always has <strong>to</strong> carry out its assessment functions within <strong>the</strong>
and in <strong>the</strong> name <strong>of</strong> <strong>the</strong> notified body. Since <strong>the</strong> notified body
<strong>the</strong> manufacturer <strong>to</strong> take corrective measures, and reporting
<strong>to</strong> <strong>the</strong> competent authority.
<strong>the</strong> notifying authority, which must be capable <strong>of</strong> ensuring
jurisdiction <strong>of</strong> <strong>the</strong> designating Member State, it shall inform
Apart from carrying out certain responsibilities in <strong>the</strong> <strong>the</strong> moni<strong>to</strong>ring <strong>of</strong> <strong>the</strong> <strong>to</strong>tal body as it has <strong>to</strong> take <strong>the</strong> responsibility
for its operations. If moni<strong>to</strong>ring is not considered
field <strong>of</strong> public interest, notified bodies must regard <strong>the</strong>mselves
as rendering services <strong>to</strong> industry. Thus, <strong>the</strong>y should possible, <strong>the</strong> notifying authority should withdraw or limit <strong>the</strong>
provide relevant information <strong>to</strong> <strong>the</strong> manufacturer and <strong>the</strong> scope <strong>of</strong> <strong>the</strong> notification as deemed necessary.
6.4. Notified bodies and conformity assessment
( 115 ) For <strong>the</strong> modules,
see Section 5.1; for
subcontracting, see
Section 6.5; and for
notified bodies’ tasks
according <strong>to</strong> <strong>the</strong>
conformity assessment
procedures, see
Annex 7.
( 116 ) For <strong>the</strong> added
value in relation with
<strong>the</strong> CE marking, see
Section 7.4.
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