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

❝ Market surveillance ❞
Although market surveillance cannot, basically, take
place during <strong>the</strong> design and production stages, <strong>the</strong> surveillance
authority may make a check on <strong>the</strong> production premises
after a non-compliance has been discovered <strong>to</strong> verify
whe<strong>the</strong>r or not a constant error can be established ( 142 ).
O<strong>the</strong>r exceptions <strong>to</strong> <strong>the</strong> principle that market surveillance
can only take place after <strong>the</strong> manufacturer has taken formal
responsibility for <strong>the</strong> products are trade fairs, exhibitions
and demonstrations. Most New Approach <strong>directives</strong> allow
<strong>the</strong> showing <strong>of</strong> non-compliant products under such circumstances,
provided that a visible sign clearly indicates that
<strong>the</strong> products may not be marketed or put in<strong>to</strong> service until
<strong>the</strong>y have been made <strong>to</strong> comply, and that adequate measures
are taken during demonstrations, where appropriate,
<strong>to</strong> ensure <strong>the</strong> protection <strong>of</strong> persons. Market surveillance
authorities must moni<strong>to</strong>r that this obligation is respected.
Market surveillance should cover all applicable provisions
<strong>of</strong> <strong>the</strong> <strong>directives</strong> in question. To a certain extent formal
checks are sufficient, for example regarding <strong>the</strong> CE
marking and its affixing, <strong>the</strong> availability <strong>of</strong> <strong>the</strong> EC declaration
<strong>of</strong> conformity, <strong>the</strong> information accompanying <strong>the</strong> product
and <strong>the</strong> correct choice <strong>of</strong> conformity assessment procedures.
More pr<strong>of</strong>ound checks are necessary <strong>to</strong> verify <strong>the</strong>
material conformity <strong>of</strong> <strong>the</strong> product, for example regarding
<strong>the</strong> correct application <strong>of</strong> <strong>the</strong> conformity assessment procedure,
<strong>the</strong> compliance with <strong>the</strong> essential requirements,
and <strong>the</strong> contents <strong>of</strong> <strong>the</strong> EC declaration <strong>of</strong> conformity. In
practice, individual market surveillance operations can
focus on certain aspects <strong>of</strong> <strong>the</strong> requirements.
Besides market surveillance operations, that have as
<strong>the</strong>ir explicit object <strong>the</strong> verification <strong>of</strong> products placed on
<strong>the</strong> market, o<strong>the</strong>r public mechanisms exist that, although
not directly designed for that aim, can never<strong>the</strong>less have as
a consequence <strong>the</strong> uncovering <strong>of</strong> non-compliance ( 143 ).
Labour inspec<strong>to</strong>rates that check safety at <strong>the</strong> workplace,
for example, can discover that <strong>the</strong> design or construction <strong>of</strong>
a machine, or personal protective equipment bearing <strong>the</strong>
CE marking, is not in conformity with <strong>the</strong> applicable requirement
( 144 ). Consequently, <strong>the</strong>y may take measures that
affect <strong>the</strong> placing on <strong>the</strong> market <strong>of</strong> a product and, thus,
carry out market surveillance, or <strong>the</strong>y may contact <strong>the</strong> market
surveillance authority that may take <strong>the</strong> necessary
measures. Information on <strong>the</strong> compliance <strong>of</strong> a product at
<strong>the</strong> moment when it was placed on <strong>the</strong> market can also be
obtained during in-use inspections, or by analysing <strong>the</strong> fac<strong>to</strong>rs
that caused an accident. Complaints from consumers
or o<strong>the</strong>r users about <strong>the</strong> product, or from manufacturers or
distribu<strong>to</strong>rs about unfair competition can also provide information
for market surveillance purposes.
Moni<strong>to</strong>ring <strong>of</strong> products placed on <strong>the</strong> market may be
divided between several authorities on <strong>the</strong> national level, for
example functionally or geographically. Where <strong>the</strong> same
products are subject <strong>to</strong> control by more than one authority
(for example cus<strong>to</strong>ms and a sec<strong>to</strong>ral authority, or local
authorities), coordination between services within a
Member State is necessary.
Voluntary initiatives, such as product certification or
application <strong>of</strong> a quality system, cannot be put on <strong>the</strong> same
footing as surveillance activities carried out by an authority.
Still, <strong>the</strong>y can contribute <strong>to</strong> <strong>the</strong> elimination <strong>of</strong> risks. However,
market surveillance authorities must be impartial, in
<strong>the</strong> light <strong>of</strong> Article 28 <strong>of</strong> <strong>the</strong> EC Treaty, regarding all voluntary
marks, labels and arrangements, and <strong>the</strong>y may only be
taken in<strong>to</strong> consideration, in a transparent and non-discrimina<strong>to</strong>ry
way, for <strong>the</strong> risk assessment. Accordingly, products
may not be excluded from market surveillance operations
even if <strong>the</strong>y have been subject <strong>to</strong> voluntary certification or
o<strong>the</strong>r voluntary initiatives.
New Approach <strong>directives</strong> provide for two different <strong>to</strong>ols
that enable surveillance authorities <strong>to</strong> receive information
on <strong>the</strong> product: <strong>the</strong> EC declaration <strong>of</strong> conformity and <strong>the</strong>
technical documentation. These must be made available by
<strong>the</strong> manufacturer, <strong>the</strong> authorised representative established
within <strong>the</strong> Community, or under certain circumstances by
<strong>the</strong> importer or person responsible for placing on <strong>the</strong> market.
O<strong>the</strong>r natural or legal persons, such as notified bodies,
distribu<strong>to</strong>rs, retailers, suppliers or subcontrac<strong>to</strong>rs, cannot
be obliged <strong>to</strong> make <strong>the</strong>se available. However, <strong>the</strong>y can
assist <strong>the</strong> surveillance authority in obtaining <strong>the</strong>m. Fur<strong>the</strong>r,
<strong>the</strong> surveillance authority may request <strong>the</strong> notified body <strong>to</strong>
provide information on <strong>the</strong> conduct <strong>of</strong> conformity assessment
for <strong>the</strong> product in question ( 145 ).
The EC declaration <strong>of</strong> conformity must be made available
for <strong>the</strong> market surveillance authority immediately upon
request. Therefore, it should be kept inside <strong>the</strong> Community.
It can be made available for surveillance purposes in each
<strong>of</strong> <strong>the</strong> Member States, for instance, by means <strong>of</strong> administrative
cooperation. A failure <strong>to</strong> present <strong>the</strong> declaration
when requested by a national surveillance authority may
constitute sufficient grounds for doubting <strong>the</strong> presumption
<strong>of</strong> conformity with <strong>the</strong> requirements <strong>of</strong> <strong>the</strong> directive ( 146 ).
The technical documentation must be made available <strong>to</strong>
<strong>the</strong> surveillance authority within a period <strong>of</strong> time commensurate
with its importance and <strong>the</strong> risk in question, but <strong>the</strong>
authority cannot request it systematically. In general, it can
be requested only during random checks made for market
surveillance purposes, or when <strong>the</strong>re are grounds for a concern
that a product does not <strong>of</strong>fer <strong>the</strong> level <strong>of</strong> protection
required in all respects. Initially <strong>the</strong> surveillance authority
may be provided with only a summary <strong>of</strong> <strong>the</strong> technical documentation
(<strong>the</strong> essential technical data), if it has been
drawn up, with reasonable time allowed for transmission.
More detailed information (for example certificates and
decisions from <strong>the</strong> notified body) can, never<strong>the</strong>less, be
requested in cases <strong>of</strong> serious doubt about <strong>the</strong> conformity <strong>of</strong>
<strong>the</strong> product <strong>to</strong> <strong>the</strong> Community regulations. The full technical
documentation should be requested only where clearly necessary,
and not, for example, when only a detail has <strong>to</strong> be
checked. This request has <strong>to</strong> be evaluated in accordance
with <strong>the</strong> principle <strong>of</strong> proportionality and, thus, taking in<strong>to</strong>
( 142 ) An explicit
provision has been
included in <strong>the</strong>
Directive relating <strong>to</strong>
<strong>to</strong>ys (Article 12).
However, such a
provision is difficult <strong>to</strong>
apply where <strong>the</strong>
manufacturing process
takes place outside <strong>the</strong>
Community.
( 143 ) According <strong>to</strong> <strong>the</strong>
Directive on highspeed
rail systems,
each Member State
authorises <strong>the</strong> putting
in<strong>to</strong> service <strong>of</strong> <strong>the</strong>
structural subsystems
in <strong>the</strong>ir terri<strong>to</strong>ry. This is
a systematic
mechanism <strong>to</strong> moni<strong>to</strong>r
<strong>the</strong> compliance <strong>of</strong>
subsystems and <strong>the</strong>ir
inter-operability
constituents.
( 144 ) Member States are
obliged, according <strong>to</strong>
<strong>the</strong> Directive on <strong>the</strong>
introduction <strong>of</strong>
measures <strong>to</strong> encourage
improvements in <strong>the</strong>
safety and health <strong>of</strong>
workers at work
(89/391/EEC), <strong>to</strong> ensure
adequate controls and
supervision.
( 145 ) For responsibilities,
see Chapter 3; for EC
declaration <strong>of</strong>
conformity, see Section
5.4; for technical
documentation, see
Section 5.3; for notified
bodies’ general
responsibilities, see
Section 6.3.
( 146 ) This does not
apply <strong>to</strong> products
covered by <strong>directives</strong>
that do not provide for
<strong>the</strong> EC declaration <strong>of</strong>
conformity, such as <strong>the</strong>
Directive relating <strong>to</strong>
<strong>to</strong>ys.
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