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

❝ <strong>Guide</strong> <strong>to</strong> <strong>the</strong> <strong>implementation</strong> <strong>of</strong> <strong>directives</strong> <strong>based</strong> on <strong>the</strong> New Approach and <strong>the</strong> Global Approach ❞
<strong>to</strong> enforce conformity. As regards personnel resources, <strong>the</strong>
authority needs <strong>to</strong> have, or have access <strong>to</strong>, a sufficient
number <strong>of</strong> suitably qualified and experienced staff, with <strong>the</strong>
necessary pr<strong>of</strong>essional integrity. To guarantee <strong>the</strong> quality <strong>of</strong>
<strong>the</strong> test data, <strong>the</strong> testing facility used by <strong>the</strong> authority should
comply with <strong>the</strong> relevant criteria <strong>of</strong> <strong>the</strong> EN 45001 standard.
The authority should also be independent, and carry out its
operations in an impartial and non-discrimina<strong>to</strong>ry way. Fur<strong>the</strong>r,
<strong>the</strong> authority should carry out market surveillance respecting
<strong>the</strong> principle <strong>of</strong> proportionality, for example action
must be in accordance with <strong>the</strong> degree <strong>of</strong> risk or noncompliance
and <strong>the</strong> impact on <strong>the</strong> free circulation <strong>of</strong>
products may not be more than is necessary for achieving
<strong>the</strong> objectives <strong>of</strong> market surveillance.
The surveillance authority may subcontract technical
tasks (such as testing or inspection) <strong>to</strong> ano<strong>the</strong>r body, provided
that it retains <strong>the</strong> responsibility for its decisions, and provided
<strong>the</strong>re is no conflict <strong>of</strong> interest between <strong>the</strong> o<strong>the</strong>r body’s
conformity assessment activities and its surveillance tasks.
In doing so <strong>the</strong> authority should exercise great care <strong>to</strong> ensure
that <strong>the</strong> impartiality <strong>of</strong> <strong>the</strong> advice it receives is beyond reproach.
The responsibility for any decision <strong>to</strong> be taken on <strong>the</strong>
basis <strong>of</strong> such advice shall reside in <strong>the</strong> surveillance authority.
As a general rule, it is inappropriate for notified bodies
<strong>to</strong> be responsible for market surveillance. In order <strong>to</strong> avoid
a conflict <strong>of</strong> interest it is necessary <strong>to</strong> make a clear distinction
between conformity assessment (which takes place
before <strong>the</strong> product is placed on <strong>the</strong> market) and market surveillance
(which takes place after <strong>the</strong> product has been
placed on <strong>the</strong> market). As an exception, where a notified
body and a market surveillance authority come under <strong>the</strong>
same superior authority in a Member State, <strong>the</strong> lines <strong>of</strong>
responsibility should be so organised that <strong>the</strong>re is no
conflict <strong>of</strong> interest between <strong>the</strong>se activities.
New Approach <strong>directives</strong> include certain provisions that
require Member States <strong>to</strong> inform <strong>the</strong> Commission or <strong>the</strong>
o<strong>the</strong>r Member States, but <strong>the</strong>y usually say nothing on <strong>the</strong>
confidentiality or transparency <strong>of</strong> information obtained
during market surveillance operations ( 137 ). Consequently,
rules on confidentiality are <strong>based</strong> on <strong>the</strong> national legal
systems, and <strong>the</strong>refore vary between Member States.
However, information on activities underway that concern
individual economic opera<strong>to</strong>rs should generally be considered
as confidential. An exception <strong>to</strong> this may be justified
where <strong>the</strong> health and safety <strong>of</strong> consumers is subject <strong>to</strong> serious
and immediate danger.
( 137 ) Directives relating
<strong>to</strong> active implantable
medical devices,
potentially explosive
atmospheres, medical
devices and in vitro
diagnostic medical
devices have
provisions on
confidentiality.
( 138 ) For placing on <strong>the</strong>
market and putting in<strong>to</strong>
service, see
Section 2.3.
( 139 ) See also
Section 8.2.3.
( 140 ) This is usually not
necessary for
consumer products
that are made available
in shops or o<strong>the</strong>rwise
on <strong>the</strong> market. It is
more important for
products (for example
machinery and
pressure equipment)
that are directly, after
being manufactured,
installed and put in<strong>to</strong>
service at <strong>the</strong> premises
<strong>of</strong> <strong>the</strong> client.
( 141 ) For <strong>the</strong>
responsibility <strong>to</strong> provide
information, see
Sections 3.1. – 3.4
and 6.3.
8.2. Market surveillance activities
● Market surveillance involves two main stages:
* national surveillance authorities shall moni<strong>to</strong>r that products
placed on <strong>the</strong> market comply with <strong>the</strong> provisions <strong>of</strong> <strong>the</strong>
applicable national legislation transposing <strong>the</strong> New Approach
<strong>directives</strong>;
* subsequently, when necessary, <strong>the</strong>y shall take action <strong>to</strong>
establish conformity.
● Although market surveillance operations cannot take place
during <strong>the</strong> design and product stages, efficient enforcement
usually requires that surveillance authorities act in collaboration
with manufacturers and suppliers in order <strong>to</strong> prevent <strong>the</strong>
placing on <strong>the</strong> market <strong>of</strong> non-compliant products.
8.2.1. Moni<strong>to</strong>ring <strong>of</strong> products placed on <strong>the</strong> market
● The objective <strong>of</strong> moni<strong>to</strong>ring products placed on <strong>the</strong> market is
<strong>to</strong> verify that <strong>the</strong>y comply with applicable <strong>directives</strong> at <strong>the</strong> moment
when placed on <strong>the</strong> market and, if relevant, when put in<strong>to</strong>
service.
● The EC declaration <strong>of</strong> conformity and <strong>the</strong> technical documentation
provide <strong>the</strong> surveillance authority with necessary
information about <strong>the</strong> product.
Market surveillance authorities must moni<strong>to</strong>r products
placed on <strong>the</strong> market. The aim is <strong>to</strong> find out whe<strong>the</strong>r or not
a product complies with <strong>the</strong> applicable provisions at <strong>the</strong>
moment when placed on <strong>the</strong> market and, if
relevant, when put in<strong>to</strong> service ( 138 ). Basically,
market surveillance cannot take place
during <strong>the</strong> design and production stages,
that is before <strong>the</strong> manufacturer has taken
formal responsibility for <strong>the</strong> conformity <strong>of</strong>
<strong>the</strong> products, usually by affixing <strong>the</strong> CE
marking. However, this does not exclude
collaboration between <strong>the</strong> surveillance
authority and <strong>the</strong> manufacturers and suppliers
( 139 ).
For market surveillance <strong>to</strong> be efficient,
resources should be concentrated where
risks are likely <strong>to</strong> be higher or non-compliance
more frequent, or where a particular
interest can be identified. Statistics and risk
assessment procedures can be used for
this purpose. To be able <strong>to</strong> moni<strong>to</strong>r products
placed on <strong>the</strong> market, surveillance
authorities shall have <strong>the</strong> power, competence
and resources:
● <strong>to</strong> regularly visit commercial, industrial
and s<strong>to</strong>rage premises;
● <strong>to</strong> regularly visit, if appropriate, work
places and o<strong>the</strong>r premises where products
are put in<strong>to</strong> service ( 140 );
● <strong>to</strong> organise random and spot checks;
● <strong>to</strong> take samples <strong>of</strong> products, and <strong>to</strong> subject <strong>the</strong>m <strong>to</strong>
examination and testing; and
● <strong>to</strong> require all necessary information ( 141 ).
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