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

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❝ Notified bodies ❞<br />

The coordinati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Member States is carried<br />

out through <str<strong>on</strong>g>the</str<strong>on</strong>g> sec<str<strong>on</strong>g>to</str<strong>on</strong>g>ral working<br />

groups <str<strong>on</strong>g>of</str<strong>on</strong>g> governmental experts established<br />

under <str<strong>on</strong>g>the</str<strong>on</strong>g> <str<strong>on</strong>g>directives</str<strong>on</strong>g> ( 118 ). The cooperati<strong>on</strong><br />

<str<strong>on</strong>g>of</str<strong>on</strong>g> notified bodies takes place under<br />

<str<strong>on</strong>g>the</str<strong>on</strong>g> authority <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> relevant working groups.<br />

Cooperati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> notified bodies is established<br />

for each <strong>New</strong> Approach directive, by<br />

usually making use <str<strong>on</strong>g>of</str<strong>on</strong>g> existing structures.<br />

Each group has a technical secretariat and<br />

a president. The cooperati<strong>on</strong> is limited <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

technical problems relating <str<strong>on</strong>g>to</str<strong>on</strong>g> c<strong>on</strong>formity<br />

assessment in order <str<strong>on</strong>g>to</str<strong>on</strong>g> ensure a uniform<br />

applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> technical provisi<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g><br />

<strong>New</strong> Approach <str<strong>on</strong>g>directives</str<strong>on</strong>g>.<br />

In recogniti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> fact that notified<br />

bodies fulfil tasks delegated <str<strong>on</strong>g>to</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g>m by public authorities<br />

<str<strong>on</strong>g>the</str<strong>on</strong>g>y must take part in coordinati<strong>on</strong> activities organised by<br />

<str<strong>on</strong>g>the</str<strong>on</strong>g> Commissi<strong>on</strong>. If a body refuses <str<strong>on</strong>g>to</str<strong>on</strong>g> cooperate, <str<strong>on</strong>g>the</str<strong>on</strong>g> notificati<strong>on</strong><br />

may be withdrawn. However, <str<strong>on</strong>g>the</str<strong>on</strong>g> notified bodies are<br />

not obliged <str<strong>on</strong>g>to</str<strong>on</strong>g> participate in meetings at European level, if<br />

<str<strong>on</strong>g>the</str<strong>on</strong>g>y keep <str<strong>on</strong>g>the</str<strong>on</strong>g>mselves informed <str<strong>on</strong>g>of</str<strong>on</strong>g>, and apply as general<br />

guidance, <str<strong>on</strong>g>the</str<strong>on</strong>g> administrative decisi<strong>on</strong>s and documents produced<br />

by <str<strong>on</strong>g>the</str<strong>on</strong>g>ir group. The relevant working documents,<br />

meeting reports, recommendati<strong>on</strong>s and guidelines elaborated<br />

by <str<strong>on</strong>g>the</str<strong>on</strong>g> sec<str<strong>on</strong>g>to</str<strong>on</strong>g>ral and intersec<str<strong>on</strong>g>to</str<strong>on</strong>g>ral groups <str<strong>on</strong>g>of</str<strong>on</strong>g> notified<br />

bodies or <str<strong>on</strong>g>the</str<strong>on</strong>g>ir subgroups will be circulated <str<strong>on</strong>g>to</str<strong>on</strong>g> all notified<br />

bodies forming part <str<strong>on</strong>g>of</str<strong>on</strong>g> those groups, whe<str<strong>on</strong>g>the</str<strong>on</strong>g>r <str<strong>on</strong>g>the</str<strong>on</strong>g>y have<br />

taken part in <str<strong>on</strong>g>the</str<strong>on</strong>g> meetings or not.<br />

The groups <str<strong>on</strong>g>of</str<strong>on</strong>g> notified bodies are composed <str<strong>on</strong>g>of</str<strong>on</strong>g> repre-<br />

6.6. Coordinati<strong>on</strong> and cooperati<strong>on</strong><br />

● A coherent applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> c<strong>on</strong>formity assessment procedures<br />

requires close cooperati<strong>on</strong> between <str<strong>on</strong>g>the</str<strong>on</strong>g> notified bodies,<br />

<str<strong>on</strong>g>the</str<strong>on</strong>g> Member States and <str<strong>on</strong>g>the</str<strong>on</strong>g> European Commissi<strong>on</strong>.<br />

● The Commissi<strong>on</strong> supports <str<strong>on</strong>g>the</str<strong>on</strong>g> Member States in <str<strong>on</strong>g>the</str<strong>on</strong>g>ir efforts<br />

<str<strong>on</strong>g>to</str<strong>on</strong>g> establish coherence between <str<strong>on</strong>g>the</str<strong>on</strong>g> notifying authorities<br />

regarding, in particular, <str<strong>on</strong>g>the</str<strong>on</strong>g> assessment <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> competence <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

<str<strong>on</strong>g>the</str<strong>on</strong>g> bodies <str<strong>on</strong>g>to</str<strong>on</strong>g> be notified, <str<strong>on</strong>g>the</str<strong>on</strong>g> applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> notificati<strong>on</strong> procedures<br />

and <str<strong>on</strong>g>the</str<strong>on</strong>g> surveillance <str<strong>on</strong>g>of</str<strong>on</strong>g> notified bodies.<br />

● The Commissi<strong>on</strong>, in coordinati<strong>on</strong> with Member States, also<br />

ensures that cooperati<strong>on</strong> is organised between <str<strong>on</strong>g>the</str<strong>on</strong>g> notified<br />

bodies.<br />

sentatives <str<strong>on</strong>g>of</str<strong>on</strong>g> notified bodies ( 119 ). To achieve a higher degree<br />

<str<strong>on</strong>g>of</str<strong>on</strong>g> efficiency in <str<strong>on</strong>g>the</str<strong>on</strong>g>ir work <str<strong>on</strong>g>the</str<strong>on</strong>g> groups can set up subgroups<br />

with a restricted number <str<strong>on</strong>g>of</str<strong>on</strong>g> participants <str<strong>on</strong>g>to</str<strong>on</strong>g> discuss specific<br />

technical questi<strong>on</strong>s. The Commissi<strong>on</strong> is represented in <str<strong>on</strong>g>the</str<strong>on</strong>g><br />

groups. Governmental experts and representatives <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> authorities<br />

directly resp<strong>on</strong>sible for <str<strong>on</strong>g>the</str<strong>on</strong>g> effective <str<strong>on</strong>g>implementati<strong>on</strong></str<strong>on</strong>g><br />

<str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> <str<strong>on</strong>g>directives</str<strong>on</strong>g> can participate as observers in <str<strong>on</strong>g>the</str<strong>on</strong>g> groups.<br />

The European standards organisati<strong>on</strong>s (CEN, Cenelec and<br />

ETSI) will be represented in <str<strong>on</strong>g>the</str<strong>on</strong>g> groups when such issues<br />

arise. The groups will also invite relevant European federati<strong>on</strong>s<br />

or representatives <str<strong>on</strong>g>of</str<strong>on</strong>g> o<str<strong>on</strong>g>the</str<strong>on</strong>g>r interested parties as observers.<br />

Where <str<strong>on</strong>g>the</str<strong>on</strong>g> groups <str<strong>on</strong>g>of</str<strong>on</strong>g> notified bodies have <str<strong>on</strong>g>to</str<strong>on</strong>g> treat<br />

subjects <str<strong>on</strong>g>of</str<strong>on</strong>g> a c<strong>on</strong>fidential nature, <str<strong>on</strong>g>the</str<strong>on</strong>g> participati<strong>on</strong> in meetings<br />

will be restricted as deemed necessary.<br />

( 118 ) See Secti<strong>on</strong> 1.2.<br />

( 119 ) Should <str<strong>on</strong>g>the</str<strong>on</strong>g> number<br />

<str<strong>on</strong>g>of</str<strong>on</strong>g> notified bodies per<br />

directive become<br />

excessive, <str<strong>on</strong>g>the</str<strong>on</strong>g><br />

Commissi<strong>on</strong> can<br />

request <str<strong>on</strong>g>the</str<strong>on</strong>g> Member<br />

States <str<strong>on</strong>g>to</str<strong>on</strong>g> put in place a<br />

proper mechanism for<br />

<str<strong>on</strong>g>the</str<strong>on</strong>g>ir representati<strong>on</strong>.<br />

43

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